[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4473-4475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02480]


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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 or Agency) 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 April 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 16, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0801 for ``Agency Information Collection Activities; 
Proposed Collection: Comment Request; Exports: Notification and 
Recordkeeping Requirements.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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

[[Page 4474]]

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 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 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 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 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) (human drugs); Center for Biologics Evaluation and Research 
(CBER) (biologics); Center for Devices and Radiological Health (CDRH) 
(medical devices); Center for Veterinary Medicine (CVM) (animal drugs); 
Center for Food Safety and Applied Nutrition (CFSAN) (foods and 
cosmetics); and Center for Tobacco Products (CTP) (tobacco products). 
Respondents to this collection of information maintain records 
demonstrating their compliance with the requirements in 21 CFR 1.101.
    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,             320               3             960              22          21,120
 CDRH, CFSAN, and CVM)..........
1.101(b) Office of International               1             189             189              22           4,158
 Programs only..................
1.101(b) (currently regulated                322               3             966              22          21,252
 Tobacco Products)..............
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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.


[[Page 4475]]


    Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02480 Filed 2-14-19; 8:45 am]
 BILLING CODE 4164-01-P