Notice2022-08739
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24321-24322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export Notification
and Recordkeeping Requirements
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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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 25, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0482. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.
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.
Export Notification and Recordkeeping Requirements
OMB Control Number 0910-0482--Extension
Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381 and 382) charge the Secretary of Health and
Human Services, through FDA, with the responsibility of helping to
ensure that exports of unapproved new drugs, biologics, devices, animal
drugs, food, cosmetics, and tobacco products that are not to be sold in
the United States meet the requirements of the country to which the
product is to be exported. The respondents to this information
collection are exporters who have notified FDA of their intent to
export unapproved products that may not be sold or offered for sale in
domestic commerce in the United States as allowed under section 801(e)
of the FD&C Act. In general, the notification
[[Page 24322]]
identifies the product being exported (e.g., name, description, and in
some cases, country of destination) and specifies where the
notifications were sent. These notifications are sent only for an
initial export. Subsequent exports of the same product to the same
destination or to certain countries identified in section 802(b) of the
FD&C Act would not result in a notification to FDA.
Respondents to the information collection are exporters of products
that may not be sold in the United States and are regulated by FDA's
Center for Drug Evaluation and Research (CDER); Center for Biologics
Evaluation and Research (CBER); Center for Devices and Radiological
Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food
Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products.
Respondents to this collection of information maintain records
demonstrating their compliance with the requirements in 21 CFR 1.101.
In the Federal Register of January 25, 2022 (87 FR 3811), FDA
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:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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1.101(d) (CBER)................. 4 35 140 15 2,100
1.101(d) (CDER)................. 3 57 171 15 2,565
1.101(d) (CDRH)................. 22 4 88 15 1,320
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Total....................... .............. .............. .............. .............. 5,985
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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1.101(b), (c), and (e) (CBER, 181 4.12 746 22 16,412
CDER, CDRH, CFSAN, and CVM)....
1.101(b) Office of International 1 65 65 22 1,430
Programs only..................
1.101(b) (currently regulated 322 3 966 22 21,252
Tobacco Products)..............
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Total....................... .............. .............. .............. .............. 39,094
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency data, we decreased our estimate by
24,251 burden hours. This decrease reflects an overall downward trend
in the number of export certification requests across programs and
commodities. The estimate for tobacco products remains steady.
Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08739 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P
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