Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
| Published date | 14 April 2021 |
| Citation | 86 FR 19622 |
| Record Number | 2021-07639 |
| Section | Notices |
| Court | Food And Drug Administration |
19622
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
subcontractors from engaging in
trafficking in persons.
•Contractors are required to provide
the compliance plan to the contracting
officer upon request.
•Contractors are required to submit a
certification to the contracting officer
annually after receiving an award,
asserting that they have the required
compliance plan in place and that there
have been no abuses, or that appropriate
actions have been taken if abuses have
been found.
•For those subcontractors required to
submit a certification (see next bullet on
flow down), contractors shall require
that submission prior to award of the
subcontract and annually thereafter.
Portions of this clause flows down to
all subcontractors. The requirements
related to the compliance plan only flow
down to subcontracts exceeding
$550,000 for supplies (other than COTS
items) acquired and services performed
outside the United States.
This clause applies to commercial
item acquisitions, except the portions
related to the compliance plan do not
apply to acquisitions of COTS items.
52.222–56, Certification Regarding
Trafficking in Persons Compliance Plan.
This provision requires apparently
successful offerors to submit a
certification, prior to award, that they
have implemented a compliance plan
and that there have been no abuses, or
that appropriate actions have been taken
if abuses have been found.
The provision requires this
certification for the portion of contracts
exceeding $550,000 for supplies (other
than COTS items) acquired and services
performed outside the United States.
This provision applies to commercial
item acquisitions, except acquisitions of
COTS items.
FAR 52.222–50, paragraph (d)—
Notification. The Government uses this
notification of potential violations of
trafficking in persons requirements to
investigate and take appropriate action
if a violation has occurred.
FAR 52.222–50, paragraph (h)—
Compliance Plan. The Government uses
the compliance plan to ascertain
compliance with the Trafficking Victims
Protection Act (22 U.S.C. 7104),
Executive Order 13627, or any other
applicable law or regulation.
FAR 52.222–50, paragraph (h) and
FAR 52.222–56—Certification. The
Government uses the certification to
obtain reasonable assurance that the
contractor and its subcontractors are
aware of and complying with the
requirements of the Executive Order and
statute.
C. Annual Burden
Respondents/Recordkeepers: 5,876.
Total Annual Responses: 11,702.
Total Burden Hours: 164,154. (25,722
reporting hours + 138,432
recordkeeping hours)).
D. Public Comment
A 60-day notice was published in the
Federal Register at 86 FR 8360, on
February 5, 2021. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov.
Please cite OMB Control No. 9000–
0188, Combating Trafficking in Persons.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2021–07571 Filed 4–13–21; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0998]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES
: Submit written comments
(including recommendations) on the
collection of information by May 14,
2021.
ADDRESSES
: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0409. Also include
the FDA docket number found in
brackets in the heading of this
document.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR part
315
OMB Control Number 0910–0409—
Extension
This information collection supports
our regulations in part 315 (21 CFR part
315) that require manufacturers of
diagnostic radiopharmaceuticals to
submit information that demonstrates
the safety and effectiveness of: (1) A
new diagnostic radiopharmaceutical; or
(2) a new indication for use of an
approved diagnostic
radiopharmaceutical. Information about
the safety or effectiveness of a
diagnostic radiopharmaceutical enables
us to properly evaluate the safety and
effectiveness profiles of such
radiopharmaceuticals.
The information, which is usually
submitted as part of a new drug
application (NDA) or biologics license
application (BLA) or as a supplement to
an approved application typically
includes, but is not limited to,
nonclinical and clinical data on the
pharmacology; toxicology; adverse
events; radiation safety assessments;
and chemistry, manufacturing, and
controls. The content and format of an
application for approval of a new drug
are set forth in § 314.50 (21 CFR 314.50)
and have been approved under OMB
control number 0910–0001. This
information collection supports part
315, which is currently approved under
OMB control number 0910–0409.
In table 1, row 1, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
an application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
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19623
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
radiopharmaceuticals, or both, we
estimate that six submissions will be
received annually and that 2,000 hours
would be spent preparing the portions
of the application that would be affected
by this information collection. We
further estimate the total time needed to
prepare complete applications for
diagnostic radiopharmaceuticals as
approximately 12,000 hours. This
information collection does not impose
any additional reporting burden for
safety and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001. In
fact, clarification of our criteria for the
evaluation of diagnostic
radiopharmaceuticals in this
information collection is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical studies.
In table 1, row 2, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
a supplement to an approved
application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
radiopharmaceuticals, or both, we
estimate that nine submissions will be
received annually. We estimate the total
time needed to prepare complete
applications for supplements to new
applications for diagnostic
radiopharmaceuticals as approximately
between 500 and 1,000 hours. We
calculated the median of this estimate to
arrive at approximately 750 hours. We
further estimate that the total time
needed to prepare the portions of the
application that would be affected by
this information collection as 6,750. As
previously stated, this information
collection does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 750 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001.
In the Federal Register of November
12, 2020 (85 FR 71923), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
T
ABLE
1—E
STIMATED
A
NNUAL
R
EPORTING
B
URDEN FOR
NDA
S AND
S
UPPLEMENTS TO
A
PPROVED
NDA
S FOR
D
IAGNOSTIC
R
ADIOPHARMACEUTICALS
1
Manufacturers’ activity (21 CFR Section) Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response Total hours
NDAs (§§ 315.4, 315.5, and 315.6) ..................................... 6 1 6 2,000 12,000
Supplements to Approved NDAs (§§ 315.4, 315.5, and
315.6) ............................................................................... 9 1 9 750 6,750
Total .............................................................................. ........................ ........................ ........................ ........................ 18,750
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 13 responses with a
corresponding increase of 14,750
burden hours, including submissions
involving NDAs. We attribute this
adjustment to an increase in the number
of submissions for NDAs for diagnostic
radiopharmaceuticals we received over
the past few years and because we are
now capturing supplements to approved
NDAs for diagnostic
radiopharmaceuticals.
Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07639 Filed 4–13–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0878]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES
: Submit written comments
(including recommendations) on the
collection of information by May 14,
2021.
ADDRESSES
: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0330. Also include
the FDA docket number found in
brackets in the heading of this
document.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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