Document ID: FDA-2010-N-0161-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
Posted Date: 2020-12-21T05:00Z

[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83091-83092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28064]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export of Food and 
Drug Administration-Regulated Products: Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 20, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0498. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Export of Food and Drug Administration-Regulated Products: Export 
Certificates

OMB Control Number 0910-0498--Extension

    Sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 381(e) and 382) pertain to the export of FDA-
regulated products and are intended to ease restrictions on 
exportation. The provisions also require the Agency to issue written 
export certifications within 20 days of any request. In January 2011, 
section 801(e)(4)(A) was amended by the FDA Food Safety Modernization 
Act (Pub. L. 111-353) to provide authorization for export certification 
for food and animal feed, as well as certain unapproved products. To 
offset Agency resource expenditures for processing certifications 
requests, the statute provides that FDA may charge firms a fee not to 
exceed $175.
    There are four FDA forms (Form FDA 3613, 3613a, 3613b, and 3613c) 
related to exporting FDA-regulated products. A description of each form 
is provided below. To obtain a fillable PDF file of each form, visit 
https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-forms-certificates-exporting. To learn more about how to 
complete these forms, visit https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-complete-fda-export-certificate-forms.

[[Page 83092]]

                     Table 1--Certificates and Uses
------------------------------------------------------------------------
          Type of certificate                          Use
------------------------------------------------------------------------
``Supplementary Information Certificate  For the export of products
 to Foreign Government Requests``.        legally marketed in the United
``Exporter's Certification Statement      States.
 Certificate to Foreign Government``..
``Exporter's Certification Statement
 Certificate to Foreign Government (For
 Human Tissue Intended for
 Transplantation)``..
``Supplementary Information Certificate  For the export of products not
 of Exportability Requests``.             approved for marketing in the
Exporter's Certification Statement        United States (unapproved
 Certificate of Exportability``..         products) that meet the
                                          requirements of sections
                                          801(e) or 802 of the FD&C Act.
``Supplementary Information Certificate  Conforms to the format
 of a Pharmaceutical Product``.           established by the World
``Exporter's Certification Statement      Health Organization and is
 Certificate of a Pharmaceutical          intended for use by the
 Product``.                               importing country when the
                                          product in question is under
                                          consideration for a product
                                          license that will authorize
                                          its importation and sale or
                                          for renewal, extension,
                                          amending, or reviewing a
                                          license.
``Supplementary Information Non-         For the export of a non-
 Clinical Research Use Only               clinical research use only
 Certificate``.                           product, material, or
``Exporter's Certification Statement      component that is not intended
 (Non-Clinical Research Use Only)``.      for human use and which may be
                                          marketed in, and legally
                                          exported from the United
                                          States under the FD&C Act.
------------------------------------------------------------------------

    Appropriate centers within FDA review product information submitted 
by firms in support of the firms' certificate requests. We rely on 
respondents to certify their compliance with all applicable 
requirements of the FD&C Act both at the time the certification request 
is submitted to FDA and at the time the certification is submitted to 
the respective foreign government. Information regarding FDA's Export 
Certificates may be found on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates.
    On September 16, 2020, we submitted an information collection 
request to the Office of Management and Budget (OMB) to revise certain 
data elements as may be applicable under the Coronavirus Aid, Relief, 
and Economic Security Act (CARES Act). Because Section 3856 of the 
CARES Act contained immediately effective provisions obligating FDA to 
review and process certification requests, we requested emergency 
processing by OMB under 5 CFR 1320.13 for the respective information 
collection. Our information collection request was granted by OMB on 
September 29, 2020. Therefore, in accordance with 5 CFR 1320.8(d)(1), 
we invite comment on the burden we attribute to the information 
collection, which we estimate as follows:

                                   Table 2--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
           FDA center                Number of     Responses per    Total Anual   Average burden    Total hours
                                    Respondents     Respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation            2,651               1           2,651               1           2,651
 and Research...................
Center for Devices and                    11,175               1          11,175               2          22,350
 Radiological Health............
Center for Drug Evaluation and             3,680               1           3,680               1           3,680
 Research.......................
Center for Veterinary Medicine..           1,925               1           1,925               1           1,925
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          30,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our current evaluation of the information collection, we 
have made no adjustments since our last request for OMB review and 
approval.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28064 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P