82 FR 56031 - Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 226 (November 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 226 (November 27, 2017)
| Page Range | 56031-56033 | |
| FR Document | 2017-25456 |
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)] [Notices] [Pages 56031-56033] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25456] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0161] Agency Information Collection Activities; Proposed Collection; 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 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 export certificates for the export of FDA- regulated products. DATES: Submit either electronic or written comments on the collection of information by January 26, 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 January 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 26, 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 [[Page 56032]] 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-2010-N-0161 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates.'' 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 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 Division of Dockets Management. 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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. Export of Food and Drug Administration-Regulated Products: Export Certificates OMB Control Number 0910-0498--Extension In April 1996, the FDA Export, Reform, and Enhancement Act of 1996 (FDAERA) (Pub. L. 104-134) amended sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(e) and 382). It was designed to ease restrictions on exportation of unapproved pharmaceuticals, biologics, and devices regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons exporting certain FDA- regulated products may request FDA to certify that the products meet the requirements of sections 801(e) and 802 or other requirements of the FD&C Act. This section of the law requires FDA to issue certification within 20 days of receipt of the request and to charge firms up to $175 for the certifications. 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 fees for food and animal feed. This section of the FD&C Act authorizes FDA to issue export certificates for regulated food, animal feed, pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the FD&C Act. FDA has developed various types of certificates that satisfy the requirements of section 801(e)(4)(B) of the FD&C Act. Four of those certificates are discussed in this notice: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, and (4) Non-Clinical Research Use Only Certificates. FDA has updated the certificates as part of the proposed collection of information to account for the amendment authorizing export certification fees for food and animal feed. Table 1 lists the different certificates and details their uses: [[Page 56033]] 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``, ``Exporter's product, material, or Certification Statement (Non-Clinical component that is not intended Research Use Only)``. for human use which may be marketed in, and legally exported from the United States under the FD&C Act. ------------------------------------------------------------------------ FDA will continue to rely on self-certification by manufacturers for the first three types of certificates listed in table 1. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the FD&C Act, not only at the time that they submit their request to the appropriate center, but also at the time that they submit the certification to the foreign government. The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to the appropriate offices. Table 2--Estimated Annual Reporting Burden 1 ---------------------------------------------------------------------------------------------------------------- Number of FDA center Number of responses per Total annual 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.. 1,819 1 1,819 1 1,819 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 30,500 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25456 Filed 11-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56031
Estimated Total/Annual Burden Desk Officer for the Administration for been approved by the Office of
Hours: 244. Children and Families. Management and Budget (OMB) under
Additional Information: Copies of the the Paperwork Reduction Act of 1995.
Mary Jones,
proposed collection may be obtained by ACF/OPRE Certifying Officer. FOR FURTHER INFORMATION CONTACT: Ila
writing to the Administration for S. Mizrachi, Office of Operations, Food
[FR Doc. 2017–25444 Filed 11–24–17; 8:45 am]
Children and Families, Office of and Drug Administration, Three White
BILLING CODE 4184–37–P
Planning, Research and Evaluation, 330 Flint North, 10A–12M, 11601
C Street SW., Washington, DC 20201, Landsdown St., North Bethesda, MD
Attn: OPRE Reports Clearance Officer. DEPARTMENT OF HEALTH AND 20852, 301–796–7726, PRAStaff@
All requests should be identified by the HUMAN SERVICES fda.hhs.gov.
title of the information collection. Email SUPPLEMENTARY INFORMATION: The
address: OPREinfocollection@ Food and Drug Administration following is a list of FDA information
acf.hhs.gov. collections recently approved by OMB
[Docket Nos. FDA–2010–N–0601, FDA–
OMB Comment: OMB is required to 2010–N–0598, FDA–2010–N–0600, FDA– under section 3507 of the Paperwork
make a decision concerning the 2007–N–0037, FDA–2010–N–0597, FDA– Reduction Act of 1995 (44 U.S.C. 3507).
collection of information between 30 2011–N–0017, and FDA–2016–N–2496] The OMB control number and
and 60 days after publication of this expiration date of OMB approval for
document in the Federal Register. Agency Information Collection each information collection are shown
Therefore, a comment is best assured of Activities; Announcement of Office of in Table 1. Copies of the supporting
having its full effect if OMB receives it Management and Budget Approvals statements for the information
within 30 days of publication. Written AGENCY: Food and Drug Administration, collections are available on the internet
comments and recommendations for the HHS. at https://www.reginfo.gov/public/do/
proposed information collection should ACTION: Notice. PRAMain. An Agency may not conduct
be sent directly to the following: Office or sponsor, and a person is not required
of Management and Budget, Paperwork SUMMARY: The Food and Drug to respond to, a collection of
Reduction Project, Email: OIRA_ Administration (FDA) is publishing a information unless it displays a
SUBMISSION@OMB.EOP.GOV, Attn: list of information collections that have currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
Current Good Manufacturing Practice for Medicated Feeds ...................................................................... 0910–0152 8/31/2020
Current Good Manufacturing Practice for Type A Medicated Articles ........................................................ 0910–0154 8/31/2020
Animal Drug User Fee Cover Sheet, Form FDA 3546 ............................................................................... 0910–0539 8/31/2020
Animal Drug User Fee Waivers and Reductions ........................................................................................ 0910–0540 8/31/2020
Index of Legally Marketed Unappropriated New Animal Drugs for Minor Species .................................... 0910–0620 8/31/2020
Voluntary National Retail Food Regulatory Program Standards ................................................................ 0910–0621 8/31/2020
Impact Trade Auxiliary Communication System ......................................................................................... 0910–0842 8/31/2020
Dated: November 20, 2017. comment on the proposed collection of at the end of January 26, 2018.
Leslie Kux, certain information by the Agency. Comments received by mail/hand
Associate Commissioner for Policy. Under the Paperwork Reduction Act of delivery/courier (for written/paper
[FR Doc. 2017–25452 Filed 11–24–17; 8:45 am] 1995 (PRA), Federal Agencies are submissions) will be considered timely
BILLING CODE 4164–01–P
required to publish notice in the if they are postmarked or the delivery
Federal Register concerning each service acceptance receipt is on or
proposed collection of information, before that date.
DEPARTMENT OF HEALTH AND including each proposed extension of an
Electronic Submissions
HUMAN SERVICES existing collection of information, and
to allow 60 days for public comment in Submit electronic comments in the
Food and Drug Administration response to the notice. This notice following way:
solicits comments on export certificates • Federal eRulemaking Portal:
[Docket No. FDA–2010–N–0161] https://www.regulations.gov. Follow the
for the export of FDA-regulated
products. instructions for submitting comments.
Agency Information Collection
Comments submitted electronically,
Activities; Proposed Collection; DATES: Submit either electronic or including attachments, to https://
Comment Request; Export of Food and written comments on the collection of www.regulations.gov will be posted to
Drug Administration-Regulated information by January 26, 2018.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
the docket unchanged. Because your
Products: Export Certificates
ADDRESSES: You may submit comments comment will be made public, you are
AGENCY: Food and Drug Administration, as follows. Please note that late, solely responsible for ensuring that your
HHS. untimely filed comments will not be comment does not include any
ACTION: Notice. considered. Electronic comments must confidential information that you or a
be submitted on or before January 26, third party may not wish to be posted,
SUMMARY: The Food and Drug 2018. The https://www.regulations.gov such as medical information, your or
Administration (FDA or Agency) is electronic filing system will accept anyone else’s Social Security number, or
announcing an opportunity for public comments until midnight Eastern Time confidential business information, such
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![Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56033
TABLE 1—CERTIFICATES AND USES
Type of certificate Use
‘‘Supplementary Information Certificate to Foreign Government Re- For the export of products legally marketed in the United States.
quests‘‘, ‘‘Exporter’s Certification Statement Certificate to Foreign
Government‘‘, ‘‘Exporter’s Certification Statement Certificate to For-
eign Government (For Human Tissue Intended for Transplantation)‘‘.
‘‘Supplementary Information Certificate of Exportability Requests‘‘, Ex- For the export of products not approved for marketing in the United
porter’s Certification Statement Certificate of Exportability’’. States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘, Conforms to the format established by the World Health Organization
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical and is intended for use by the importing country when the product in
Product‘‘. question is under consideration for a product license that will author-
ize its importation and sale or for renewal, extension, amending, or
reviewing a license.
‘‘Supplementary Information Non-Clinical Research Use Only Certifi- For the export of a non-clinical research use only product, material, or
cate‘‘, ‘‘Exporter’s Certification Statement (Non-Clinical Research component that is not intended for human use which may be mar-
Use Only)‘‘. keted in, and legally exported from the United States under the
FD&C Act.
FDA will continue to rely on self- FD&C Act, not only at the time that they The appropriate FDA centers will
certification by manufacturers for the submit their request to the appropriate review product information submitted
first three types of certificates listed in center, but also at the time that they by firms in support of their certificate
table 1. Manufacturers are requested to submit the certification to the foreign and any suspected case of fraud will be
self-certify that they are in compliance government. referred to the appropriate offices.
with all applicable requirements of the
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA center responses per burden per Total hours
respondents responses
respondent response
Center for Biologics Evaluation and Research .................... 2,651 1 2,651 1 2,651
Center for Devices and Radiological Health ....................... 11,175 1 11,175 2 22,350
Center for Drug Evaluation and Research .......................... 3,680 1 3,680 1 3,680
Center for Veterinary Medicine ............................................ 1,819 1 1,819 1 1,819
Total .............................................................................. ........................ ........................ ........................ ........................ 30,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 20, 2017. Homogenous Cases of Product Without • Federal eRulemaking Portal: https://
Leslie Kux, a Product Identifier.’’ This draft www.regulations.gov. Follow the
Associate Commissioner for Policy. guidance specifies whether and under instructions for submitting comments.
[FR Doc. 2017–25456 Filed 11–24–17; 8:45 am] what circumstances packages and Comments submitted electronically,
BILLING CODE 4164–01–P
homogenous cases of product not including attachments, to https://
labeled with a product identifier shall www.regulations.gov will be posted to
be exempted, as grandfathered, from the docket unchanged. Because your
DEPARTMENT OF HEALTH AND certain requirements of the Federal comment will be made public, you are
HUMAN SERVICES Food, Drug, and Cosmetic Act (the solely responsible for ensuring that your
FD&C Act). comment does not include any
Food and Drug Administration confidential information that you or a
DATES: Submit either electronic or
[Docket No. FDA–2017–D–6526] written comments on the draft guidance third party may not wish to be posted,
by January 26, 2018 to ensure that the such as medical information, your or
Grandfathering Policy for Packages Agency considers your comment on this anyone else’s Social Security number, or
and Homogenous Cases of Product draft guidance before it begins work on confidential business information, such
Without a Product Identifier; Draft the final version of the guidance. as a manufacturing process. Please note
Guidance for Industry; Availability Submit either electronic or written that if you include your name, contact
comments concerning the collection of information, or other information that
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AGENCY: Food and Drug Administration, information proposed in the draft identifies you in the body of your
HHS. guidance by January 26, 2018. comments, that information will be
ACTION: Notice of availability. posted on https://www.regulations.gov.
ADDRESSES: You may submit comments
SUMMARY: The Food and Drug on any guidance at any time as follows: • If you want to submit a comment
Administration (FDA, the Agency, or Electronic Submissions with confidential information that you
we) is announcing the availability of a do not wish to be made available to the
draft guidance for industry entitled Submit electronic comments in the public, submit the comment as a
‘‘Grandfathering Policy for Packages and following way: written/paper submission and in the
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Document Created: 2017-11-25 01:09:16
Document Modified: 2017-11-25 01:09:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by January 26, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 56031 |
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