Document ID: FDA-2014-N-0801-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping
Requirements
Posted Date: 2014-07-03T04:00Z

[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Pages 38036-38037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15647]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0801]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Exports: Notification and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on export notification and recordkeeping 
requirements for persons exporting human drugs, biological products, 
devices, animal drugs, food, cosmetics, and tobacco that may not be 
marketed or sold in the United States.

DATES: Submit either electronic or written comments on the collection 
of information by September 2, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 
are not 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 markets 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).
    FDA estimates the burden of this collection of information as 
follows:

[[Page 38037]]

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of                          Average
         21 CFR section               No. of       responses per   Total  annual    burden per     Total  hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
1.101(d) (Non-Tobacco products).              73             503          36,719              15         550,785
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of                          Average
         21 CFR section               No. of        records per    Total  annual    burden per     Total  hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (Non-                 320               3             960              22          21,120
 Tobacco Products)..............
1.101(b) (Non-Tobacco Products                 1             189             189              22           4,158
 for Office of International
 Programs only).................
1.101(b) (Tobacco Products Only)             158               3             474              22          10,428
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          35,706
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15647 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P