83 FR 133 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 1 (January 2, 2018)

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 the information collection provisions associated with export certificate applications for FDA-regulated food and cosmetic products.

[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 133-135]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food and Cosmetic Export Certificate Application 
Process

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 the information collection provisions 
associated with export certificate applications for FDA-regulated food 
and cosmetic products.

DATES: Submit either electronic or written comments on the collection 
of information by March 5, 2018.

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 March 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 5, 2018. 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-2347 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food and Cosmetic Export 
Certificate Application Process.'' 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

[[Page 134]]

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.thefederalregister.org/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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Food and Cosmetic Export Certificate Application Process

OMB Control Number 0910-0793--Revision

    Some countries may require manufacturers of FDA-regulated products 
to provide certificates for products they wish to export to that 
country. Accordingly, firms exporting products from the United States 
often ask FDA to provide such a ``certificate.'' In many cases, foreign 
governments are seeking official assurance that products exported to 
their countries can be marketed in the United States, or that they meet 
specific U.S. requirements. In some cases, review of an FDA export 
certificate may be required as part of the process to register or 
import a product into another country. An export certificate generally 
indicates that the particular product is marketed in the United States 
or otherwise eligible for export and that the particular manufacturer 
has no unresolved enforcement actions pending before, or taken by, FDA. 
FDA's Center for Food Safety and Applied Nutrition (CFSAN) issues 
export certificates for food and cosmetic products. Interested persons 
may request a certificate electronically via the Certificate 
Application Process (CAP), a component of the FDA Industry Systems, or 
by contacting CFSAN for assistance. To facilitate the application 
process we have eliminated paper-based forms. For food products, we 
have expanded the electronic options for providing facility and product 
information. Respondents will now be able to identify facilities based 
on a food facility registration number, FDA Establishment 
Identification (FEI) number, or Data Universal Numbering System (DUNS) 
number. The system uses these identifiers to locate and auto-populate 
name and address information, eliminating the need for users to 
manually enter this information and reducing the time to complete the 
application. Respondents can also upload product information via a 
spreadsheet, which reduces the time needed to enter product 
information, particularly for applications that include multiple 
products. All information is entered using electronic Forms FDA 3613d, 
3613e, 3613g, and 3613l and used to evaluate certificate requests.
    While burden associated with information collection activities for 
export certificates issued for other FDA-regulated products is approved 
under OMB control no. 0910-0498, this collection specifically supports 
export certificates issued by CFSAN. Also, because we have eliminated 
paper-based forms, respondents who require assistance with completing 
export certificate applications online may contact CFSAN directly by 
email ([email protected]) or telephone (240-402-
2307). Instructions for Form FDA 3613d are available online at https://www.fda.gov/cosmetics/internationalactivities/exporters/ucm353912.htm 
and instructions for Form FDA 3613e are available online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260280.htm. Draft screenshots of Form FDA 3613g and 3613l are 
available for comment online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
    Description of Respondents: The respondents to this collection of 
information are firms interested in exporting U.S.-manufactured food 
and cosmetic products to foreign countries that require export 
certificates.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 135]]



                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                                                             Number of                    Average burden
            Type of respondent                     FDA Form No.\2\           Number of     responses per   Total annual    per response     Total hours
                                                                            respondents     respondent       responses      (in hours)
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Cosmetics.................................  FDA 3613d...................             270               3             810             0.5             405
Food......................................  FDA 3613e, 3613g, 3613l.....             881               5           4,405             0.5           2,203
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............           2,608
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via the Certificate Application Process (CAP).

    We have revised the currently approved burden estimate for the 
information collection to reflect the elimination of paper-based forms. 
Specifically, and based on our experience with the information 
collection, we have reduced the estimated time to prepare a submission 
from 1.5 hours to 0.5 hour. The previous estimate was based on the time 
necessary to prepare a paper submission, but all firms requesting 
export certificates now provide submissions electronically via CAP. We 
believe that the time to prepare an electronic submission is under 0.25 
hour, but are estimating 0.5 hour as a conservative approach to address 
all scenarios. We base our estimates of the total annual responses on 
our experience with certificate applications received in the past 3 
fiscal years.
    We expect that most firms requesting export certificates in the 
next 3 years will choose to take advantage of the option of electronic 
submission via CAP. If a firm is unable to submit their information via 
CAP, they may contact CFSAN and request assistance. CFSAN will assist 
firms in entering their information into the electronic system so that 
the firm may receive their export certificates in a timely manner. Our 
burden estimates in Table 1 are based on the expectation of 100 percent 
participation in the electronic submission process. Providing the 
opportunity to submit the information in electronic format has reduced 
our previous estimates for the time to prepare each submission.

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28258 Filed 12-29-17; 8:45 am]
 BILLING CODE 4164-01-P