[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]
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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.
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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
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Type of certificate Use
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``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.
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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
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Number of
FDA center Number of Responses per Total Anual Average burden Total hours
Respondents Respondent responses per response
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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
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Total....................... .............. .............. .............. .............. 30,606
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\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]
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