[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Notices]
[Pages 23055-23056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10537]


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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; Exports: Notification 
and Recordkeeping Requirements

AGENCY: Food and Drug Administration, 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: Fax written comments on the collection of information by June 
20, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0482. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

Exports: Notification and Recordkeeping Requirements--21 CFR 1.101

OMB Control Number 0910-0482--Extension

    Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 381) charges 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 which are not to be sold in the United 
States

[[Page 23056]]

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 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 (21 U.S.C. 382(b)) would not result in a 
notification to FDA.
    The recordkeepers for this information collection are exporters of 
products that may not be sold in the United States who are regulated by 
the following FDA Centers: 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 (CTP). Respondents to this collection of 
information maintain records demonstrating their compliance with the 
requirements in 21 CFR 1.101.
    In the Federal Register of February 15, 2019 (84 FR 4473), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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)....................................................                5               92              460               15            6,900
1.101(d) (CDER)....................................................                5              180              900               15           13,500
1.101(d) (CDRH)....................................................              160                1              160               15            2,400
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    Total..........................................................  ...............  ...............  ...............  ...............           22,800
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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), (e) (CBER, CDER, CDRH, CFSAN, and CVM).............              320                3              960               22           21,120
1.101(b) Office of International Programs only.....................                1              189              189               22            4,158
1.101(b) (currently regulated Tobacco Products)....................              322                3              966               22           21,252
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    Total..........................................................  ...............  ...............  ...............  ...............           46,530
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have adjusted our burden estimate, which has resulted in an 
overall decrease of 129,543 hours to the currently approved burden. The 
reporting burden estimate for CDRH has been adjusted to correct an 
error and corresponding miscalculation in the previous burden estimate 
and has been updated based on recent internal data. This adjustment 
contributed to the overall burden estimate reduction by eliminating 
8,030 responses and 120,450 hours from the reporting burden estimate. 
CBER's estimated reporting burden for the information collection in 
table 1 reflects a decrease of 7,575 hours and a corresponding decrease 
of total annual responses (193 to 92). We attribute this adjustment to 
a normal variation in the number of submissions we received over the 
last few years. CTP's current number of respondents and recordkeeping 
burden hours in table 2 are expected to decrease by 23 respondents and 
1,518 hours. This is based on summary derived from the monthly 
operational reports that manufacturers and importers of tobacco 
products are required to file with the Alcohol and Tobacco Tax and 
Trade Bureau.

    Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10537 Filed 5-20-19; 8:45 am]
 BILLING CODE 4164-01-P