Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process, 133-135 [2017-28258]

Download as PDF Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES General advice is provided where modifications of the prescribing information for specific products are needed. FDA previously issued draft guidance on the prescribing information for COCs in March 2004 and invited public comment. That draft guidance was withdrawn in July 2015. However, the development of the current draft guidance took into consideration public comments submitted to the 2004 draft guidance that were science-based and consistent with current PLR and PLLR labeling regulations. This draft guidance has been broadened to incorporate the more general class of CHCs. FDA invites comments on the content of this draft guidance. In particular, FDA seeks comments on the proposed language under section 7.1 of labeling that identifies a drug interaction with all metabolic enzyme inducers. A variety of metabolic enzyme inducers have been reported to decrease the plasma concentration of the estrogen and/or progestin components of CHCs. FDA seeks comments and data regarding specific enzyme inducers or classes of inducers (e.g., cytochrome p450 3A strong inducers) that interact with CHCs; in particular, comments are requested on whether the CHC labeling should include specific inducers or classes of inducers, or if it should remain broad and essentially cover all possible cytochrome p (CYP) enzyme inducers of any pathway and potency. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on labeling for CHCs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 201.56 and 201.57 (‘‘Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products’’) are approved under OMB control number 0910–0572. The collections of information from the final rule entitled ‘‘Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 for Pregnancy and Lactation Labeling’’ are approved under OMB control number 0910–0624. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov/. Dated: December 26, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28252 Filed 12–29–17; 8:45 am] BILLING CODE 4164–01–P 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. 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 FDAregulated 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 SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 133 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 E:\FR\FM\02JAN1.SGM 02JAN1 daltland on DSKBBV9HB2PROD with NOTICES 134 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 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/201523389.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, 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 VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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 autopopulate 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 FDAregulated products is approved under OMB control no. 0910–0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paperbased forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email (CFSANExportCertification@ fda.hhs.gov) 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: E:\FR\FM\02JAN1.SGM 02JAN1 135 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Type of respondent FDA Form No.2 Cosmetics ........................... Food .................................... FDA 3613d ......................... FDA 3613e, 3613g, 3613l .. 270 881 3 5 810 4,405 0.5 0.5 405 2,203 Total ............................. ............................................. ........................ ........................ ........................ ........................ 2,608 Total hours 1 There 2 All are no capital costs or operating and maintenance costs associated with this collection of information. 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. daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neuroendocrinology, Neuroimmunology, Rhythms and Sleep Study Section. Date: February 1–2, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: New Orleans Marriott, 555 Canal Street, New Orleans, LA 70130. Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301–435– 1119, mselmanoff@csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function A Study Section. Date: February 1–2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Dallas Downtown, 1015 Elm Street, Dallas, TX 75202. Contact Person: David R. Jollie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD 20892, (301)–408– 9072, jollieda@csr.nih.gov. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Medical Imaging Study Section. Date: February 1–2, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Catamaran Resort, 3999 Mission Boulevard, San Diego, CA 92109. Contact Person: Xiang-Ning Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, 301–435– 1744, lixiang@csr.nih.gov. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies A Study Section. Date: February 1, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Marines’ Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102. Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435– 1712, ryansj@csr.nih.gov. Name of Committee: Vascular and Hematology Integrated Review Group; Atherosclerosis and Inflammation of the Cardiovascular System Study Section. Date: February 1–2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico Boulevard, Santa Monica, CA 90405. Contact Person: Natalia Komissarova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, MSC 7846, Bethesda, MD 20892, 301–435– 1206, komissar@mail.nih.gov. Name of Committee: Oncology 2— Translational Clinical Integrated Review Group; Developmental Therapeutics Study Section. Date: February 1–2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Bayside, 4875 North Harbor Drive, San Diego, CA 92106. Contact Person: Sharon K. Gubanich, Ph.D., Scientific Review Officer, Center for E:\FR\FM\02JAN1.SGM 02JAN1

Agencies

[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 133-135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28258]


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

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.

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

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.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: 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

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