Document ID: FDA-2014-N-0801-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports:
Notification and Recordkeeping Requirements
Posted Date: 2014-10-14T04:00Z

[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61643-61644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24293]

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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 
November 13, 2014.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

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 (the FD&C 
Act) (21 U.S.C. 381) charges the Secretary of Health and Human 
Services, through FDA, with the responsibility of assuring exports 
(Exports: Notification and Recordkeeping Requirements--Sec.  1.101 (21 
CFR 1.101)) which pertain to the exportation of unapproved new drugs, 
biologics, devices, animal drugs, food, cosmetics, and tobacco products 
that are not to be sold in the United States.
    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 marketed 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 in 
the case of certain countries identified in section 802(b) of the FD&C 
Act (21 U.S.C. 382) would not result in a notification to FDA.
    The recordkeepers to this information collection are exporters who 
export human drugs, biologics, devices, animal drugs, foods, cosmetics, 
and tobacco products that may not be sold in the United States and 
maintain records demonstrating their compliance with the requirements 
in section 801(e)(1) of the FD&C Act.
    On March 30, 2012, OMB approved ``Further Amendments to General 
Regulations of the Food and Drug Administration to Incorporate Tobacco 
Products,'' OMB control number 0910-0690, which amended, among other 
sections, Sec.  1.101 to incorporate tobacco products. This amendment 
reflects the Agency's authority over tobacco products under the Family 
Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) and added 
tobacco products to the list of products covered under Sec.  1.101(a) 
and (b).
    In the Federal Register of July 3, 2014 (79 FR 38036), 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:

[[Page 61644]]

                                 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) (Non-Tobacco products).              73             503          36,719              15         550,785
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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) (Non-Tobacco Products ).....................             320                3              960               22           21,120
1.101(b) (Non-Tobacco Products for Office of International Programs               1              189              189               22            4,158
 only).............................................................
1.101(b) (Tobacco Products Only)...................................             158                3              474               22           10,428
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    Total..........................................................  ...............  ...............  ...............  ...............          35,706
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24293 Filed 10-10-14; 8:45 am]
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