Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
| Published date | 14 March 2019 |
| Record Number | 2019-04716 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 50 (Thursday, March 14, 2019)
[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9347-9352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04716]
[[Page 9347]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0242]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practices for Positron
Emission Tomography Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on FDA's regulations on current good
manufacturing practice (CGMP) for positron emission tomography (PET)
drugs.
DATES: Submit either electronic or written comments on the collection
of information by May 13, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 13, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0242 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practices for Positron Emission Tomography Drugs.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance
[[Page 9348]]
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Current Good Manufacturing Practice (CGMP) for Positron Emission
Tomography Drugs
OMB Control Number 0910-0667--Extension
PET is a medical imaging modality involving the use of a unique
type of radiopharmaceutical drug product. Our CGMP regulations at part
212 (21 CFR part 212) are intended to ensure that PET drug products
meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) regarding safety, identity, strength, quality, and purity. The
CGMP requirements for PET drugs are issued under the provisions of the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115). These CGMP requirements are designed according to the unique
characteristics of PET drugs, including their short half-lives, and the
fact that most PET drugs are produced at locations close to the
patients to whom the drugs are administered.
The CGMP regulations require the establishment of written
procedures as well as recordkeeping related to ongoing manufacturing of
individual PET drugs, testing, and product release activities,
including any third-party disclosure requirements for producing PET
drugs. To estimate time spent to comply with the requirements, we
relied on informal communications with PET producers, FDA staff visits
to PET facilities, our familiarity with PET and general pharmaceutical
manufacturing practices with application and supplement submissions,
and various reports FDA received from 2016 through 2018.
I. Investigational and Research PET Drugs
Section 212.5(b) (21 CFR 212.5(b)) provides that for
investigational PET drugs produced under an investigational new drug
application (IND) and research PET drugs produced with approval of a
Radioactive Drug Research Committee (RDRC), the requirement (FD&C Act)
to follow CGMP is met by complying with the regulations under part 212
or complying with United States Pharmacopeia (USP) 32 Chapter 823. We
believe that PET production facilities producing drugs under INDs and
RDRCs are already substantially complying with the recordkeeping
requirements of USP 32 Chapter 823 (see section 121(b) of FDAMA). Some
IND and RDRC PET facilities also produce approved NDA (new drug
application) and abbreviated new drug application (ANDA) PET drugs.
While we do not have sufficient information to estimate burdens for all
IND and RDRC PET facilities, our estimates have included those
facilities that also produce NDA and ANDA PET drugs. Those facilities
are included under academic and small firms.
II. Recordkeeping Burden
A. One-Time Burden for Corporate Firms
We estimate corporate firms will have to employ one-time and
ongoing annual recordkeeping. There are three major PET manufacturing
corporations and most of the quality, manufacturing, and testing
procedures are developed at the corporate level and then issued to the
individual sites located in various States across the country. There
are an estimated 115 such sites under three major corporations. Thus,
the burden has been calculated for 3 recordkeepers instead of 115
individual sites.
It would take approximately 8 hours for each corporate firm to
create one master batch record per drug, and an average of three PET
drugs have been taken into consideration. We also estimate that
approximately 3 firms will create and maintain approximately 27 records
associated with production and quality testing for an average of 3
drugs, with a total recordkeeping burden of approximately 216 hours.
Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) (21 CFR
212.20(c), 212.30(b), 212.50(d), and 212.60(f)) contain standard
operating procedures (SOPs) dealing with equipment operation,
maintenance, and cleaning, including maintenance of physical
facilities.
It would take approximately 5 hours for each corporate firm to
establish and maintain procedures for equipment and facility
maintenance. We estimate that the 3 corporate firms will establish and
maintain 39 procedures, with a total recordkeeping burden of
approximately 195 hours.
Sections 212.20(c) and 212.40(a) and (b) contain requirements on
SOPs regarding receiving, testing, and accepting components. We
estimate that the burden for corporate firms to create procedures for
acceptance of raw materials and components would be approximately 8
hours and that there will be approximately three corporate firms
performing these activities, with a total recordkeeping burden of
approximately 48 hours. The burden for corporate firms to create
component specification data sheets would be approximately 2 hours with
approximately 3 corporate firms performing these activities, with a
total recordkeeping burden of approximately 150 hours for approximately
25 component specification sheets for each firm.
Sections 212.20(c) and 212.71(a) and (b) require that PET drug
firms establish procedures for investigating ``deviations'' and ``out
of specifications failures'' of products during manufacturing and
testing that do not conform to specifications and to conduct these
investigations and record them as needed. We estimate that it will take
approximately 8 hours for three corporate firms to establish one
procedure, with a total recordkeeping burden of approximately 24 hours.
Sections 212.20(c) and 212.90(a) require that written procedures
regarding distribution of PET drug products be established and
maintained. We estimate that it will take approximately 8 hours for
each corporate firm to establish written procedures regarding
distribution of PET drugs with a total of approximately three records,
with a total recordkeeping burden of approximately 24 hours.
Sections 212.20(c) and 212.100(a), (b), and (c) require that PET
drug firms establish and maintain written procedures for handling
complaints and procedures for field alert reports (FARs). We estimate
that each corporate firm will create three written procedures to
establish complaints and FARs process and it will take approximately 24
hours for each corporate firm. A total of 72 hours will be required to
create 27 procedures by 3 corporate firms.
B. One-Time Burden for Academia, Small Firms, and Precursors
There is a total of 52 sites combined for academic and small
commercial firms, including some IND and RDRC sites. There are nine
starting material/precursors/sterile raw material manufacturing
entities who are required to follow selected regulations from part 212,
according to the PET drug definition under section 121(a) of FDAMA and
codified in section 201(ii)(1)(A) of the FD&C Act (21 U.S.C.
321(ii)(1)(A)). We will refer to them as high-risk component
manufacturing firms in the tables and other sections of this document.
It would take approximately 8 hours for each firm to perform the
same activities as corporate firms regarding creating master batch
records and manufacturing and quality procedures.
[[Page 9349]]
We estimate that there will be a total of approximately 488 records,
with a total recordkeeping burden of approximately 3,904 hours.
It would take approximately 8 hours for each firm to create
equipment and facility related procedures as corporate firms. We also
estimate that there will be a total of approximately 793 records, with
a total recordkeeping burden of approximately 6,344 hours.
We also estimate that the burden for each firm to create and
maintain specification sheets would be approximately 2 hours and that
there will be a total of approximately 61 firms performing these
activities, with a total recordkeeping burden of approximately 3,050
hours. Furthermore, the burden for these firms to create and maintain
procedures for acceptance of raw materials and components would be
approximately 8 hours and that there will be a total of approximately
61 firms performing these activities, with a total recordkeeping burden
of approximately 976 hours.
It would take approximately 8 hours for each firm to perform the
same activities as corporate firms. We estimate that there will be a
total of approximately 61 records, with a total recordkeeping burden of
approximately 488 hours.
We estimate that 61 academia, small firms, and high-risk component
manufacturers will create about one procedure related to deviations and
out of specifications and that each firm will expend approximately 8
hours, for a total of 488 hours. Similarly, 488 hours will be spent for
procedures on distribution of PET drugs. There will be 3 procedures
created by each firm related to customer complaints, recalls, and FARs,
with a total of 156 records from 52 sites and a total of 1,248 hours.
C. Annual Burden for Corporate Firms
In this section, we considered 115 individual corporate sites under
the 3 major corporations in our estimates. These activities will be
related to individual PET drugs manufactured at each of the sites
located across the country. We estimate that it would take 30 minutes
each to fill 144 batches (approximately 4 batches/month), for a total
of 8,280 hours. In the second row of table 3, we have also estimated
that on an annual basis, some new batch records or quality records may
have to be created for newly introduced or existing drugs. It would
take each firm approximately 24 hours for three new quality procedure/
master batch records, with a total recordkeeping burden of
approximately 216 hours for nine records from three corporate
organizations.
We estimate that 115 individual corporate sites belonging to 3
major corporate entities will create 164 records for equipment
maintenance, cleaning, calibration, and facilities maintenance records,
with a total recordkeeping burden of 9,430 hours.
Sections 212.20(c) and 212.40(a) and (b) also set out requirements
for raw material and component shipments received at the manufacturing
facility on an ongoing basis. We estimate that the burden for each firm
to create incoming raw material acceptance records for 2 shipments per
month and 30 minutes per shipment will be 1,380 hours for 2,760 records
from 115 sites.
Sections 212.60(g), 212.61(b), and 212.70(d)(2) and (3) set out
requirements for documenting laboratory testing results from each PET
drug manufactured referred to in laboratory testing, including final
release testing. Each firm must keep records of different tests for
each of their products. We estimate that approximately 115 corporate
sites will document 144 records of cumulative quality control (QC) test
results (one record with 5 to 6 tests included), with a total
recordkeeping burden of approximately 8,280 hours.
We estimate that each firm will take approximately 1 hour to record
out-of-specification (OOS) events and perform investigations for each
incident. We also estimate an average of 2 ``Out of Specification''
investigations per firm, with a total of 230 records for ``OOS''
investigations from 115 sites, which results in a burden of 460 hours.
This estimate includes any reprocessing or special release events,
which are very rare.
Section 212.100(b) and (c) requires that PET drug firms document
how each complaint is handled. We estimate that this will take
approximately 2 hours for each site to document and investigate one
complaint. We estimated 2 complaints per year per site, with a total
expended hour of 460 hours for 115 individual sites. We believe the
estimate is appropriate since not all sites receive complaints.
We also estimate annual recordkeeping for PET drug firms to perform
quality assurance (QA) and release of manufactured PET drugs from the
115 corporate sites to be 4,140 hours, for a total of 144 released
batches estimating 15 minutes per batch.
Section 212.90(b) requires that corporate firms maintain
distribution records. We estimate that it will take each firm
approximately 15 minutes to create a distribution record for each batch
of PET drug products, with a total burden of approximately 4,140 hours
for 144 released batches from 115 sites.
D. Annual Burden for Academia and Small Firms
It is estimated that each firm will expend the same amount of time
to perform the same activities as corporate firms. Approximately 52
academia and small firms will fill 1,248 batch and production records,
totaling 624 hours. For any new master batch record or quality
procedures we have estimated 156 total records (3 per site), with a
total of 1,248 hours.
For calibration and cleaning records like filling information in
log books for each piece of equipment and documenting calibration
records in each PET production firm, we estimate approximately 30
minutes on average for each piece of equipment for all firms. The
calibration efforts are once per year per equipment, with estimated 10
pieces of equipment per site. We estimate that 52 academic and small
firms will record a total of 884 hours for 34 records per site and a
total of 1,768 records.
For Sec. Sec. 212.20(c) and 212.40(a) and (b), approximately 1,768
raw material and component acceptance records will be filled on an
ongoing annual basis. We estimate that the burden for each firm to
create incoming raw material acceptance records for 12 shipments per
year and 30 minutes per shipment will be 312 hours for 624 records from
52 sites.
We also estimate that approximately 52 academia and small firms
will document 1,248 laboratory QC tests for 24 batches of drugs, with a
total recordkeeping burden of approximately 624 hours.
We estimate that each firm will take approximately 1 hour each to
record OOS and customer complaint events and perform investigations. We
also estimate that an average of two ``Out of Specification'' and
customer complaints and investigations per firm, with a total of 208
hours for each category. This estimate has included any reprocessing or
special batch release events, which have been rarely observed.
We also estimate annual recordkeeping for PET drug firms to perform
QA and release of manufactured PET drugs from 52 sites to be 312 hours,
for a total of 24 batches per site released if estimating 15 minutes
per batch.
Section 212.90(b) requires that corporate firms maintain
distribution records. We estimate that it will take approximately 15
minutes to create a distribution record for each batch of
[[Page 9350]]
PET drug products, with a total burden of approximately 312 hours for
24 batches per site.
E. Annual Burden for High-Risk Component Manufacturers
According to section 121(a) of FDAMA, the PET drug definition
includes any non-radioactive or radioactive reagents, kits, nuclidic
generators, target materials, synthesizers, and so forth. FDA performs
risk assessments of each manufacturer and inspects such manufacturers.
Sterile manufacturers and complex labels fall under this category,
including sterile raw material or reagent manufactures. We have
estimated nine such facilities based on inspections so far and have
included them in this section. These manufacturers must comply with
selected sections of part 212 since they are not final PET drug
manufacturers. We will refer to them as high-risk component
manufacturers in general in this document.
We estimate that it would take 9 high-risk component manufacturers
about 30 minutes to fill each manufacturing batch records (12 per year)
and that there will be a total of approximately 108 records, with a
total recordkeeping burden of approximately 54 hours.
We also estimate that it will take nine component manufacturers 30
minutes to fill and create equipment and facilities related records,
with a total recordkeeping burden of 72 hours.
We estimate that 9 high-risk component manufacturers will document
54 components, containers, and closures for incoming acceptance tests,
with a total recordkeeping burden of approximately 27 hours.
We estimate that 9 high-risk component manufacturers will document
12 QC records related to 12 batches, with a total recordkeeping burden
of approximately 54 hours.
We also estimate annual recordkeeping for PET drug firms to perform
QA and release manufactured PET drugs from 9 sites to be 27 hours, for
a total of 108 batches released, estimating 15 minutes per batch.
We further estimate that it would take each precursor 15 minutes to
create and maintain distribution records and that there will be
approximately 108 records, with a total recordkeeping burden of
approximately 27 hours.
III. Process Verification
Section 212.50(f)(2) requires that any process verification
activities and results be recorded. Process verification is usually
performed as a one-time activity before a product is approved or if any
major manufacturing process or equipment changes are made. This effort
to conduct process verification has been estimated under annual new
creation of master batch records and manufacturing and quality
procedures in section II of this document.
IV. Conditional Final Releases
Section 212.70(f) requires PET drug producers to document any
conditional final releases of a product. We believe that conditional
final releases will be uncommon, and we have them estimated under
annual ``OOS'' investigations and final QA release efforts for each
manufactured batch.
V. Reprocessing Procedures
Sections 212.20(c) and 212.71(d) require PET drug producers to
establish and document procedures for reprocessing PET drugs. We rarely
see any reprocessing option being submitted for application of such
drugs and, if reprocessing occurs, we have estimated such rare events
under annual QA release efforts.
VI. Third-Party Disclosure Burden
Section 212.70(e) requires that PET drug producers notify all
receiving facilities if a batch fails sterility tests. FDA receives
FARs reports based on confirmed sterility failures of released PET
drugs. Based on our experience of such reporting, we estimated a total
of 12 failures from all 167 sites (corporate, small firms, and
academia). Therefore, we have estimated that 12 PET drug producers will
file 2 reports to FDA and send a notification to the affected clinical/
receiving site per year. PET drug producers would transmit the notice
by email or Fax and submit the FARs notice to FDA electronically, with
2 hours per incident in total.
We estimate the burden of the information collection as follows:
Table 1--Estimated One-Time Recordkeeping Burden for Corporate Firms \1\
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Number of Average burden
Activity/type of respondent/21 Number of records per One-time per Total hours
CFR section recordkeepers recordkeeper records recordkeeper \2\
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Batch Production and Control 3 9 27 8 216
Records (Sec. Sec. 212.20(c)
and (e) and 212.50(a) and (b)).
Equipment and Facilities Records 3 13 39 5 195
(SOP) (Sec. Sec. 212.20(c),
212.30(b) 212.50(d), and
212.60(f)).....................
Records of Components, 3 2 6 8 48
Containers, and Closures (SOP)
(Sec. Sec. 212.20(c) and
212.40(a) and (b)).............
Records of Components, 3 25 75 2 150
Containers, and Closures
(specifications data sheets)
(Sec. Sec. 212.20(c) and
212.40(a) and (b)).............
Out-of-Specification 3 1 3 8 24
Investigations (SOP) (Sec.
Sec. 212.20(c) and 212.71(a))
Distribution Records (SOP) (Sec. 3 1 3 8 24
Sec. 212.20(c) and
212.90(a)).....................
Complaints, Recalls (Sec. Sec. 3 3 9 8 72
212.20(c) and 212.100(a)).....
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Total....................... .............. .............. .............. .............. 729
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Number rounded to the nearest whole number.
[[Page 9351]]
Table 2--Estimated One-Time Recordkeeping Burden for Academia, Small Firms, and High-Risk Component
Manufacturers \1\
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Number of Average burden
Activity/type of respondent/21 Number of records per One-time per Total hours
CFR section recordkeepers recordkeeper records recordkeeper \2\
----------------------------------------------------------------------------------------------------------------
Batch Production and Control 61 8 488 8 3,904
Records (Sec. Sec. 212.20(c)
and (e) and 212.50(a) and (b)).
Equipment and Facilities Records 61 13 793 8 6,344
(SOP) (Sec. Sec. 212.20(c),
212.30(b) 212.50(d), and
212.60(f)).....................
Records of Components, 61 25 1,525 2 3,050
Containers, and Closures
(specification only) (Sec.
Sec. 212.20(c) and 212.40(a)
and (b)).......................
Records of Components, 61 2 122 8 976
Containers, and Closures (SOP)
(Sec. Sec. 212.20(c) and
212.40(a) and (b)).............
Out-of-Specification 61 1 61 8 488
Investigations (SOP) (Sec.
Sec. 212.20(c) and 212.71(a))
Distribution Records (SOP) (Sec. 61 1 61 8 488
Sec. 212.20(c) and
212.90(a)).....................
Complaints, Recalls (Sec. Sec. 52 3 156 8 1,248
212.20(c) and 212.100(a)).....
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Total....................... .............. .............. .............. .............. 16,498
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Number rounded to the nearest whole number.
Table 3--Estimated Annual Recordkeeping Burden for Corporate Firms \1\
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Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records \2\
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Batch Production (Creating Manufacturing 115 144 16,560 0.50 (30 minutes)........................ 8,280
Records) (creating batch-related records per
year) (Sec. Sec. 212.20(c) and (e) and
212.50(a) and (b)).
Creating Any New Batch Records/Quality 3 9 27 8........................................ 216
Records for New or Existing Drugs (Sec.
Sec. 212.20(c) and (e) and 212.50(a) and
(b)).
Equipment and Facilities Records (calibration 115 164 18,860 0.50 (30 minutes)........................ 9,430
and cleaning records systems) (Sec. Sec.
212.30(b), 212.50(d), and 212.60(f)).
Records of Components, Containers, and 115 24 2,760 0.50 (30 minutes)........................ 1,380
Closures (Sec. Sec. 212.20(c) and
212.40(a) and (b)).
Laboratory Testing Records (record laboratory 115 144 16,560 0.50 (30 minutes)........................ 8,280
test results) (Sec. Sec. 212.60(g),
212.61(b), and 212.70(d)(2) and (3)).
Out-of-Specification Investigations (record 115 2 230 2........................................ 460
events and investigations) (Sec.
212.71(b)).
Complaints (Sec. Sec. 212.100(b) and (c)). 115 2 230 2........................................ 460
QA and Release of Batches.................... 115 144 16,560 0.25 (15 minutes)........................ 4,140
Distribution Records (Sec. 212.90(b))...... 115 144 16,560 0.25 (15 minutes)........................ 4,140
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Total.................................... .............. .............. .............. ......................................... 36,786
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number rounded to the nearest whole number.
Table 4--Estimated Annual Recordkeeping Burden for Academia and Small Firms \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Batch Production (creating manufacturing 52 24 1,248 0.50 (30 minutes)........................ 624
records) (filling batch related records per
year) (Sec. Sec. 212.20(c) and (e) and
212.50(a) and (b)).
Creating Any New Batch Records/Procedures for 52 3 156 8........................................ 1,248
New Drugs (Sec. Sec. 212.20(c) and (e)
and 212.50(a) and (b)).
Equipment and Facilities Records (calibration 52 34 1,768 0.50 (30 minutes)........................ 884
and cleaning records) (Sec. Sec.
212.30(b), 212.50(d), and 212.60(f)).
Records of Components, Containers, and 52 12 624 0.50 (30 minutes)........................ 312
Closures (incoming acceptance tests) (Sec.
Sec. 212.20(c) and 212.40(a) and (b)).
Laboratory Testing Records (QC test results) 52 24 1,248 0.50 (30 minutes)........................ 624
(Sec. Sec. 212.60(g), 212.61(b) and
212.70(d)(2) and (3)).
[[Page 9352]]
Out-of-Specification Investigations (record 52 2 104 2........................................ 208
events and investigations) (Sec.
212.71(b)).
Complaints (Record events and investigations) 52 2 104 2........................................ 208
(Sec. Sec. 212.100(b) and (c)).
QA and Release of Batches.................... 52 24 1,248 0.25 (15 minutes)........................ 312
Distribution Records (Sec. 212.90(b))...... 52 24 1,248 0.25 (15 minutes)........................ 312
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Total.................................... .............. .............. .............. ......................................... 4,732
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number rounded to the nearest whole number.
Table 5--Estimated Annual Recordkeeping Burden for High Risk Component Manufacturers \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records \2\
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Batch Production (creating manufacturing 9 12 108 0.50 (30 minutes)........................ 54
records and batch related records per year)
(Sec. Sec. 212.20(c) and (e) and
212.50(a) and (b)).
Equipment and Facilities Records (calibration 9 16 144 0.50 (30 minutes)........................ 72
and cleaning records systems) (Sec. Sec.
212.30(b), 212.50(d), and 212.60(f)).
Records of Components, Containers, and 9 6 54 0.50 (30 minutes)........................ 27
Closures (incoming acceptance test) (Sec.
Sec. 212.20(c) and 212.40(a) and (b)).
Laboratory Testing Records (record QC test 9 12 108 0.50 (30 minutes)........................ 54
results) Sec. Sec. 212.60(g), 212.61(b)
and 212.70(d)(2) and (3).
Out-of-Specification Investigations (Record 9 1 9 1........................................ 9
events and investigations) (Sec.
212.71(b)).
QA and Release of Batches.................... 9 12 108 0.25 (15 minutes)........................ 27
Distribution Records (Sec. 212.90(b))...... 9 12 108 0.25 (15 minutes)........................ 27
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Total.................................... .............. .............. .............. ......................................... 270
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number rounded to the nearest whole number.
Table 6--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
sterility Number of Total annual Average burden per
Activity/21 CFR section failure disclosures per disclosures disclosure Total hours
incidents respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sterility Test Failure Notices (Sec. 212.70(e)).............. 12 \2\ 3 36 2.5 90
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ There are two reports sent to FDA per incident and notification to receiving site.
These burden estimates reflect adjustments since last OMB approval.
Previously we had based the estimated number of respondents on the
number of individual production sites, however we believe using the
number of registered organizations better reflects the burden
attributable to information collection. This results in an overall
decrease to the collection.
Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04716 Filed 3-13-19; 8:45 am]
BILLING CODE 4164-01-P
