Notice2024-04155
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the 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.
Full Text
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<title>Federal Register, Volume 89 Issue 41 (Thursday, February 29, 2024)</title>
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[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14882-14883]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04155]
[[Page 14882]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4259]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export Certificates
for Food and Drug Administration Regulated Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the 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 April 1, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#7f2f2d3e2c0b1e19193f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="59090b180a2d383f3f193f3d387731312a773e362f">[email protected]</span></a>.
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 Certificates for FDA Regulated Products
OMB Control Number 0910-0498--Revision
This information collection supports the implementation of FDA
statutory and regulatory provisions and related forms. 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. To offset Agency resource expenditures for
processing certifications requests, the statute provides that FDA may
charge firms a fee not to exceed $175.
The information collection contains FDA forms (Form FDA 3613,
3613a, 3613b, 3613c, 3613f, and 3613g) related to exporting FDA-
regulated products. A description of each form is provided in table 1.
Table 1--Certificates and Uses
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Type of certificate/Form FDA# Use
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Form FDA 3613: ``Supplementary For the export of products
Information Certificate to Foreign legally marketed in the United
Government Requests''. States.
``Exporter's Certification Statement
Certificate to Foreign Government''.
``Exporter's Certification Statement
Certificate to Foreign Government (For
Human Tissue Intended for
Transplantation)''.
Form FDA 3613a: ``Supplementary For the export of products not
Information Certificate of approved for marketing in the
Exportability Requests''. United States (unapproved
``Exporter's Certification Statement products) that meet the
Certificate of Exportability''. requirements of sections
801(e) or 802 of the FD&C Act.
Form FDA 3613b and Form FDA 3613f: Conforms to the format
``Supplementary Information established by the World
Certificate of a Pharmaceutical Health Organization and is
Product''. intended for use by the
``Exporter's Certification Statement importing country when the
Certificate of a Pharmaceutical product in question is under
Product''. consideration for a product
license that will authorize
its importation and sale or
for renewal, extension,
amending, or reviewing a
license.
Form FDA 3613c: ``Supplementary For the export of a non-
Information Non-Clinical Research Use clinical research use only
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.
Form FDA 3613g: ``Certificate to For the shipping of devices not
Foreign Government for Devices Not exported from the United
Exported from the United States''. States that may be legally
marketed in the United States.
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To obtain a fillable PDF file of each form, visit <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>, and type ``3613'' in
the search field. We accept online applications for export certificates
for specific product areas through web-based application systems. To
access these web-based application systems, visit the FDA Industry
Systems web page at <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. For additional
information on export certification processing for specific product
areas refer to the following websites: <a href="https://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products">https://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products</a>, (CBER); <a href="https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices">https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices</a> (CDRH); <a href="https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information">https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information</a> (CDER); and <a href="https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs">https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs</a> (CVM).
We are transitioning to a requirement for electronic submission of
the forms related to medical device products. Therefore, we revised FDA
Forms 3613, 3613a, 3613c, and 3613g to remove the paper submission
instructions in the portions of the forms related to medical device
products.
We developed the guidance document ``FDA Export Certification''
(August 2021) which is intended to provide a general description of FDA
export certification to industry and foreign governments. The guidance
document is available from our website at: <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm">https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm</a>. Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115,
[[Page 14883]]
which provide for public comment at any time.
In the Federal Register of October 25, 2023 (88 FR 73349), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Forms FDA 3613, 3613a, 3613b, Number of
3613c, 3613f, and 3613g; Number of responses per Total annual Average burden Total hours
submission to FDA center respondents respondent responses per response
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Center for Biologics Evaluation 2,344 1 2,344 1 2,344
and Research (CBER)............
Center for Devices and 11,175 1 11,175 2 22,350
Radiological Health (CDRH).....
Center for Drug Evaluation and 9,396 1 9,396 1 9,396
Research (CDER)................
Center for Veterinary Medicine 1,618 1 1,618 1 1,618
(CVM)..........................
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Total....................... 24,533 .............. 24,533 .............. 35,708
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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. Further information regarding FDA's
Export Certificates may be found on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates</a>.
The estimated burden for the information collection reflects an
overall adjustment increase of 5,102 hours and a corresponding increase
of 5,102 responses. CDER has instituted electronic certificates of
pharmaceutical product (eCPP) to streamline the application process and
reduce the time from receipt to issuance of export certificates. The
increase in CDER export application requests is attributable to the
implementation of the eCPP and an increase in drug exports. The
increase is offset by a decrease in CVM and CBER export applications
attributable to consequences of the COVID-19 pandemic. In addition,
revised form instructions related to medical device products are
included in the information collection request.
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04155 Filed 2-28-24; 8:45 am]
BILLING CODE 4164-01-P
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