[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Pages 38036-38037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15647]
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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.
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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, [email protected].
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\
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No. of Average
21 CFR section No. of responses per Total annual burden per Total hours
respondents respondent responses 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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No. of Average
21 CFR section No. of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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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
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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: 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