Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability
| Published date | 07 October 2021 |
| Citation | 86 FR 55847 |
| Record Number | 2021-21970 |
| Section | Notices |
| Court | Food And Drug Administration |
55847
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
advisory committee information line to
learn about possible modifications
before joining the meeting.
SUPPLEMENTARY INFORMATION
: Consistent
with FDA’s regulations, this notice is
being published with less than 15 days
prior to the date of the meeting based on
a determination that convening a
meeting of the Vaccines and Related
Biological Products Advisory
Committee as soon as possible is
warranted. This Federal Register notice
could not be published 15 days prior to
the date of the meeting due to recent
requests to amend the Emergency Use
Authorization (EUA) of the Moderna
COVID–19 mRNA vaccine for the
administration of a booster dose,
following completion of the primary
series, to individuals 18 years of age and
older, and also the EUA of the Janssen
Biotech Inc. COVID–19 vaccine for the
administration of a booster dose, to
individuals 18 years of age and older,
and the need for prompt discussion of
such requests given the COVID–19
pandemic.
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On October
14, 2021, under Topic 1, the committee
will meet in open session to discuss the
EUA of the Moderna COVID–19 mRNA
vaccine for the administration of a
booster dose, following completion of
the primary series, to individuals 18
years of age and older. On October 15,
2021, under Topic II, the committee will
meet in open session to discuss the EUA
of the Janssen Biotech Inc. COVID–19
vaccine for the administration of a
booster dose, to individuals 18 years of
age and older.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, background material will be
made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/advisory-
committee-calendar. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see
ADDRESSES
) on or before
October 12, 2021, will be provided to
the committee. Comments received after
October 12, 2021, and by October 13,
2021, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled approximately
between 12:45 p.m. and 1:45 p.m.
Eastern Time on October 14, 2021, and
approximately between 11 a.m. and 12
noon Eastern Time on October 15, 2021.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before 6 p.m. October 8, 2021. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 12, 2021.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Prabhakara
Atreya or Kathleen Hayes
(CBERVRBPAC@fda.hhs.gov) at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at:
https://www.fda.gov/advisory-
committees/about-advisory-committees/
public-conduct-during-fda-advisory-
committee-meetings for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–22037 Filed 10–5–21; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0271]
Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act; Revised Draft Guidance for
Industry; Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Hospital and
Health System Compounding Under
Section 503A of the Federal Food, Drug,
and Cosmetic Act’’ (‘‘revised draft
guidance’’). This revised draft guidance,
when finalized, will describe how FDA
intends to apply certain provisions of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to human drug products
compounded by State-licensed
pharmacies that are not outsourcing
facilities and distributed for use within
a hospital or health system. First, it
addresses the requirement that
compounding be based on the receipt of
a valid prescription order for an
identified individual patient. Second, it
addresses the provision concerning
compounded drug products that are
essentially copies of a commercially
available drug product. This draft
guidance revises the draft guidance
issued in 2016 entitled, ‘‘Hospital and
Health System Compounding Under the
Federal Food, Drug, and Cosmetic Act’’
(‘‘draft guidance’’). FDA is revising the
draft guidance to address stakeholder
feedback and provide further
clarification on policies regarding
hospital and health system
compounding. This revised draft
guidance is not final nor is it in effect
at this time.
DATES
: Submit either electronic or
written comments on the revised draft
guidance by December 6, 2021 to ensure
that the Agency considers your
comment on this revised draft guidance
before it begins work on the final
version of the guidance. Submit
electronic or written comments on the
proposed collection of information in
the revised draft guidance by December
6, 2021.
ADDRESSES
: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1
lotter on DSK11XQN23PROD with NOTICES1
55848
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
•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–
2016–D–0271 for ‘‘Hospital and Health
System Compounding Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ Received comments 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, 240–402–7500.
•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.govinfo.gov/content/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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this revised draft guidance to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the revised draft guidance may be
sent. See the
SUPPLEMENTARY
INFORMATION
section for information on
electronic access to the revised draft
guidance.
FOR FURTHER INFORMATION CONTACT
:
With regard to the revised draft
guidance: Tracy Rupp, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993, 301–796–3100.
With regard to the proposed collection
of information: 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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act.’’ Pharmacies located within a
hospital, or standalone pharmacies that
are part of a health system, frequently
provide compounded drug products for
administration within the hospital or
health system. Some of these
compounders seek to compound under
section 503A of the FD&C Act (21 U.S.C.
353a) and others have registered with
FDA as outsourcing facilities and are
subject to section 503B of the FD&C Act
(21 U.S.C. 353b).
Section 503A of the FD&C Act
describes the conditions that must be
satisfied for human drug products
compounded by a licensed pharmacist
in a State-licensed pharmacy or Federal
facility, or by a licensed physician, to be
exempt from the following three
sections of the FD&C Act:
•Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP)
requirements);
•Section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
drugs with adequate directions for use);
and
•Section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications or abbreviated
new drug applications).
This revised draft guidance proposes
policies for FDA’s application of certain
provisions of section 503A of the FD&C
Act to human drug products
compounded by State-licensed
pharmacies that are not outsourcing
facilities and distributed for use within
a hospital or health system. First, the
revised draft guidance addresses the
requirement that compounding be based
on the receipt of a valid prescription
order for an identified individual
patient. Second, it addresses the
provision concerning compounded drug
products that are essentially copies of a
commercially available drug product.
This revised draft guidance does not
apply to human drug products
compounded by outsourcing facilities
under section 503B of the FD&C Act,
compounded drug products that are not
distributed for use within a hospital or
health system, or drug products
compounded for use in animals.
In the Federal Register of April 18,
2016 (81 FR 22610), FDA announced the
availability of a draft guidance for
industry entitled, ‘‘Hospital and Health
System Compounding Under the
Federal Food, Drug, and Cosmetic Act’’
VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1
lotter on DSK11XQN23PROD with NOTICES1
55849
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
(‘‘draft guidance’’). The draft guidance
proposed new policies for the
application of section 503A of the FD&C
Act to drug products compounded by
licensed pharmacists or physicians in
State-licensed hospital or health system
pharmacies. In particular, the draft
guidance described certain
circumstances under which FDA
generally would not intend to take
action if a hospital or health system
pharmacy distributed compounded drug
products without first receiving a
patient-specific prescription or order.
The comment period on the initial
draft guidance ended on July 18, 2016.
FDA received approximately 76
comments on the draft guidance. FDA is
issuing a revised draft guidance with
certain changes made in response to
received comments or on its own
initiative. For example, the prescription
requirement enforcement policy
described in the revised draft guidance
does not consider whether the drug
products are distributed only to
healthcare facilities that are located
within a 1-mile radius of the
compounding pharmacy (‘‘1-mile radius
policy’’). Instead, the Agency is
proposing a two-part, risk-based
compliance policy.
In addition, the revised draft guidance
proposes new policies for hospital and
health system pharmacies regarding the
provision in section 503A of the FD&C
Act which states that to qualify for the
exemptions under section 503A of the
FD&C Act, among other conditions, a
drug product must be compounded by
a licensed pharmacist or physician who
does not compound regularly or in
inordinate amounts any drug products
that are essentially copies of a
commercially available drug product.
FDA is issuing this revised draft
guidance to address stakeholders’
feedback, reflect additional Agency
consideration of the proposed policies,
and enable the public to further review
and comment before finalization.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Hospital
and Health System Compounding Under
Section 503A of the Federal Food, Drug,
and Cosmetic Act.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3521),
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
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.
We are consolidating the information
collection in the revised draft guidance
with the information collections and
approvals under OMB control number
0910–0800.
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
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.
Human Drug Compounding Under
Sections 503A and 503B the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910–0800—
Revision
This notice solicits comments on
certain information collections found in
the revised draft guidance entitled
‘‘Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act’’ (‘‘revised draft guidance’’). This
guidance, when finalized, will support
implementation of the copies provisions
of the 1997 Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) discussed
in section 503A of the FD&C Act, which
were maintained by the 2013 Drug
Quality and Security Act (DQSA) (Title
I of Pub. L. 113–54).
For efficiency of Agency operations,
we are revising OMB control number
0910–0800 to include information
collections relating to the copies
policies for hospital and health system
pharmacies that are not outsourcing
facilities, as proposed in the revised
draft guidance document.
As proposed in section III.B of the
revised draft guidance, among other
conditions, we generally would not
intend to take action against a hospital
or health system pharmacy that is not an
outsourcing facility for compounding a
drug product regularly or in inordinate
amounts that is essentially a copy of a
commercially available drug product, if
the compounded drug product is
administered only to patients within the
hospital or health system and the
pharmacy obtains from the prescriber a
statement that: (1) Specifies a change
between the compounded drug product
and the commercially available drug
product; (2) indicates that the
compounded drug product will be
administered only to patients for whom
the change produces a significant
difference from the commercially
available drug product; and (3)
describes the intended patient
population for the compounded drug
product. In addition, the revised draft
guidance specifies that the statement
would be maintained in the hospital or
health system pharmacy to address
routine orders for patients for whom the
change produces a significant
difference, and a statement would be on
file for each prescriber that covers each
drug product that is compounded.
As provided in section III.B of the
revised draft guidance, except for the
policy proposed above regarding the
documentation of a prescriber’s
determination of significant difference,
we propose to apply the policies
described in the guidance,
‘‘Compounded Drug Products That Are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act’’ (‘‘503A copies
guidance’’) to drug products
compounded by hospital and health
system pharmacies that are not
outsourcing facilities.
As described in section III.B.2 of the
503A copies guidance, and proposed in
the revised draft guidance to apply to
hospital and health system pharmacies,
if a compounder intends to rely on a
prescriber determination of significant
difference to establish that a
compounded drug is not essentially a
copy of a commercially available drug
product, the compounder should ensure
that the determination is documented
on the prescription. If a prescription
VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1
lotter on DSK11XQN23PROD with NOTICES1
55850
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
does not make clear that the prescriber
made the determination required by
section 503A(b)(2) of the FD&C Act, or
a compounded drug is substituted for
the commercially available drug
product, the compounder can contact
the prescriber and if the prescriber
confirms it, make a notation on the
prescription that the compounded drug
product contains a change that makes a
significant difference for the patient.
The notations should be as specific as
those described in the 503A copies
guidance, and the date of the
conversation with the prescriber should
be included on the prescription.
With respect to the determination of
significant difference described above,
we estimate that, annually, a total of
approximately 3,075 hospital or health
system pharmacies (table 1) will obtain
a prescriber determination of significant
difference. This estimate represents
approximately half of the hospitals in
the United States, including those that
are in health systems. Of these, we
estimate that approximately half (1,538)
will have hospital or health system
pharmacies that will follow the policy
in the revised draft guidance, obtaining
a statement of significant difference for
the intended patient population, and
approximately half (1,537) will have
hospital or health system pharmacies
that will follow the policy with respect
to prescriber determination of
significant difference in the 503A copies
guidance, documenting the notation on
the individual patient prescription. This
estimate assumes that most pharmacies
in smaller hospitals and health systems
will follow the policy in the 503A
copies guidance because a prescriber
determination of significant difference
will not be routinely needed and can be
most efficiently managed on a patient-
by-patient basis. On the other hand, this
estimate assumes that most pharmacies
in larger hospitals and health systems
will follow the policy in the revised
draft guidance because the need for a
prescriber determination of significant
difference is more routinely necessary
and, therefore, most efficiently managed
with a statement of significant
difference that is maintained in the
hospital or health system pharmacy to
address routine orders for patients for
whom the change produces a significant
difference.
We estimate that, annually,
approximately 1,538 hospital or health
system pharmacies following the policy
in the revised draft guidance will obtain
approximately 30 statements of
significant difference for compounded
drug products, for a total of
approximately 46,140 statements (table
1, row 1). We estimate that the
consultation between the hospital or
health system pharmacy and the
prescriber to obtain the statement of
significant difference will require
approximately 5 minutes per statement
(table 1, row 1).
We estimate that, annually,
approximately 1,537 hospital or health
pharmacies following the policy in the
503A copies guidance will consult a
prescriber to determine whether the
prescriber has made a determination
that the compounded drug product has
a change that produces a significant
difference for a patient as compared to
the comparable commercially available
drug and that the compounders will
document this determination on
approximately 76,850 prescription
orders for compounded drug products
(table 1, row 2). We estimate that the
consultation between the compounder
and the prescriber and adding a notation
to each prescription that does not
already document this determination
will take approximately 3 minutes per
prescription order (table 1, row 2). The
average burden per consultation and
notation for pharmacies following the
significant difference policy in the 503A
copies guidance, compared to
pharmacies following the significant
difference policy in the revised draft
guidance, is estimated to be less (3
minutes) because the significant
difference determination described in
the 503A copies policy is specific to one
patient, whereas the statement of
significant difference in the revised
draft guidance describes the intended
patient population.
In addition, as described in section
III.B.3 of the 503A copies guidance, and
proposed in the revised draft guidance
to apply to hospital and health system
pharmacies, if the drug product was
compounded because the approved drug
product was not commercially available
because it was on the FDA drug shortage
list, the prescription or a notation on the
prescription should note that it was on
the drug shortage list and note the date
the list was checked. We estimate that
a total of approximately 4,613 hospital
or health system pharmacies will
document this information on
approximately 922,600 prescription
orders for compounded drug products
(table 1, row 3). We estimate that
checking FDA’s drug shortage list and
documenting this information will
require approximately 2 minutes per
prescription order (table 1, row 3).
With respect to maintaining records of
the statement of significant difference
proposed in section III.B of the revised
draft guidance, we estimate that a total
of approximately 1,538 hospital or
health system pharmacies will maintain
approximately 46,140 statements of
significant difference (table 2, row 1).
We estimate that maintaining the
records will require approximately 2
minutes per record (table 2, row 1).
With respect to maintaining records of
the significant difference determination,
as provided in section III.B.5 of the
503A copies guidance, we estimate that
a total of approximately 1,537 hospital
or health system pharmacies will
maintain approximately 76,850 records
(table 2, row 2). We estimate that
maintaining records will require
approximately 2 minutes per record
(table 2, row 2).
Also with respect to maintenance of
records, as described in section III.B.5 of
the 503A copies guidance, and proposed
in the revised draft guidance to apply to
hospital and health system pharmacies,
compounders under section 503A
should maintain records of (1) the
frequency in which they have
compounded drug products that are
essentially copies of commercially
available drug products and (2) the
number of prescriptions that they have
filled for compounded drug products
that are essentially copies of
commercially available drug products.
We estimate that a total of
approximately 3,075 hospital or health
system pharmacies will maintain
approximately 61,500 records of
prescriptions that they have filled for
compounded drug products that are
essentially copies of commercially
available drug products (table 2, row 3).
We estimate that maintaining the
records will require approximately 2
minutes per record (table 2, row 3).
We estimate the burden of this
collection of information as follows:
VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1
lotter on DSK11XQN23PROD with NOTICES1
55851
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
T
ABLE
1—E
STIMATED
A
NNUAL
T
HIRD
-P
ARTY
D
ISCLOSURE
B
URDEN
1
Activity Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures Average burden
per disclosure Total hours
Consultation between the hospital or health system pharmacy and the prescriber
to document the statement of significant difference (revised draft guidance). 1,538 30 46,140 .08 (5 minutes) ..... 3,691
Consultation between the hospital or health system pharmacy and prescriber and
the notation on the prescription documenting the prescriber’s determination of
significant difference (503A copies guidance).
1,537 50 76,850 .05 (3 minutes) ..... 3,843
Hospital or health system pharmacy checking FDA’s drug shortage list and docu-
menting on the prescription that the drug is in shortage (503A copies guidance). 4,613 200 922,600 .03 (2 minutes) ..... 27,678
Total .................................................................................................................... .................... ........................ .................... ............................... 35,212
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
T
ABLE
2—E
STIMATED
A
NNUAL
R
ECORDKEEPING
B
URDEN
1
Activity Number of
record-
keepers
Number of
records per
recordkeeper
Total annual
records Average burden
per recordkeeping Total hours
Records of the statement of significant difference (revised draft guidance) ............. 1,538 30 46,140 .03 (2 minutes) ..... 1,384
Records of documentation of significant difference (503A copies guidance) ........... 1,537 50 76,850 .03 (2 minutes) ..... 2,306
Records of frequency and number of prescriptions filled for compounded drug
products that are essentially a copy (503A copies guidance). 3,075 20 61,500 .03 (2 minutes) ..... 1,845
Total .................................................................................................................... .................... ........................ .................... ............................... 5,535
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
revised draft guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–21970 Filed 10–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Request for comments on the draft
Department Strategic Plan for FY
2022–2026
AGENCY
: Office of the Secretary, Office
of the Assistant Secretary for Planning
and Evaluation, Health and Human
Services.
ACTION
: Request for comments on the
draft HHS Strategic Plan FY 2022–2026.
SUMMARY
: The Department of Health and
Human Services (HHS) is seeking public
comment on its draft Strategic Plan for
Fiscal Years 2022–2026 through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/index.html.
DATES
: Submit comments on or before
November 7, 2021.
ADDRESSES
: Written comments can be
provided by email, Fax, or U.S. mail.
Email: HHSPlan@hhs.gov.
Fax: (202) 690–5882.
Mail: U.S. Department of Health and
Human Services, Office of the Assistant
Secretary for Planning and Evaluation,
Division of Strategic Planning, Attn:
Strategic Plan Comments, 200
Independence Avenue SW, Room 434E,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT
:
Margo Bailey, (202) 730–8504.
SUPPLEMENTARY INFORMATION
: The draft
Department of Health and Human
Services Strategic Plan FY 2022–2026 is
provided as part of the strategic
planning process under the Government
Performance and Results Modernization
Act of 2010 (GPRA–MA)(Pub. L. 111–
352) to ensure that Agency stakeholders
are given an opportunity to comment on
this plan.
This document articulates how the
Department will achieve its mission
through five strategic goals. These five
strategic goals are (1) Protect and
Strengthen Equitable Access to High
Quality and Affordable Health Care, (2)
Safeguard and Improve National and
Global Health Conditions and
Outcomes, (3) Strengthen Social Well-
being, Equity, and Economic Resilience,
(4) Restore Trust and Accelerate
Advancements in Science and Research
for All, and (5) Advance Strategic
Management to Build Trust,
Transparency, and Accountability. Each
goal is supported by objectives and
strategies.
The strategic planning consultation
process is an opportunity for the
Department to refine and strengthen the
HHS Strategic Plan FY 2022–2026. We
look forward to receiving your
comments by November 7, 2021. The
text of the draft HHS Strategic Plan FY
2022–2026 is available through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/index.html. For
comparison purposes, the current HHS
Strategic Plan FY 2018–2022 can be
viewed at https://www.hhs.gov/about/
strategic-plan/index.html.
For those who may not have internet
access, a hard copy can be requested
from the contact point, Margo Bailey,
(202) 730–8504.
Dated: September 29, 2021.
Rebecca Haffajee,
Acting Assistant Secretary for Planning and
Evaluation (ASPE), Principal Deputy, ASPE.
[FR Doc. 2021–21939 Filed 10–5–21; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Public Comments on the
Development of the 2021–2022 IACC
Strategic Plan for Autism Spectrum
Disorder (ASD)
SUMMARY
: On behalf of the Interagency
Autism Coordinating Committee (IACC),
the National Institute of Mental Health
(NIMH) Office of Autism Research
VerDate Sep<11>2014 23:02 Oct 06, 2021 Jkt 256001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1
lotter on DSK11XQN23PROD with NOTICES1
