Document ID: FDA-2014-N-0801-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
Posted Date: 2022-04-25T04:00Z

[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24321-24322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0482. 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, 
[email protected].

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]
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