83 FR 7195 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 83, Issue 34 (February 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7195-7196 | |
| FR Document | 2018-03346 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Notices] [Pages 7195-7196] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03346] ----------------------------------------------------------------------- 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) 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: Fax written comments on the collection of information by March 22, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0498. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. 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 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 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: 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 which may be marketed in, and legally exported from the United States under the FD&C Act. ------------------------------------------------------------------------ [[Page 7196]] 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. In the Federal Register of November 27, 2017 (82 FR 56031), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. The burden hours have decreased from the previous approval. Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average FDA Center Number of responses per Total annual burden per Total hours respondents respondent responses 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. Dated: February 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03346 Filed 2-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7195
II. Delegations of Authority that a proposed collection of designed to ease restrictions on
Pending further delegation, directives, information has been submitted to the exportation of unapproved
or orders by the Commissioner of Food Office of Management and Budget pharmaceuticals, biologics, and devices
and Drugs, all delegations and (OMB) for review and clearance under regulated by FDA. Section 801(e)(4) of
redelegations of authority made to the Paperwork Reduction Act of 1995. FDAERA provides that persons
officials and employees of affected DATES: Fax written comments on the exporting certain FDA-regulated
organizational components will collection of information by March 22, products may request FDA to certify
continue in them or their successors 2018. that the products meet the requirements
pending further redelegations, provided ADDRESSES: To ensure that comments on of sections 801(e) and 802 or other
they are consistent with this the information collection are received, requirements of the FD&C Act. This
reorganization. OMB recommends that written section of the law requires FDA to issue
comments be faxed to the Office of certification within 20 days of receipt of
III. Electronic Access Information and Regulatory Affairs, the request and to charge firms up to
Persons interested in seeing the OMB, Attn: FDA Desk Officer, Fax: 202– $175 for the certifications. In January
complete Staff Manual Guide can find it 395–7285, or emailed to oira_ 2011, section 801(e)(4)(A) was amended
on FDA’s website at: http:// submission@omb.eop.gov. All by the FDA Food Safety Modernization
www.fda.gov/AboutFDA/Reports comments should be identified with the Act (Pub. L. 111–353) to provide
ManualsForms/StaffManualGuides/ OMB control number 0910–0498. Also authorization for export certification
default.htm. include the FDA docket number found fees for food and animal feed.
Dated: December 21, 2017. in brackets in the heading of this
document. This section of the FD&C Act
Eric D. Hargan authorizes FDA to issue export
Acting Secretary of Health and Human FOR FURTHER INFORMATION CONTACT: certificates for regulated food, animal
Services. Amber Sanford, Office of Operations, feed, pharmaceuticals, biologics, and
[FR Doc. 2018–03402 Filed 2–16–18; 8:45 am] Food and Drug Administration, Three devices that are legally marketed in the
BILLING CODE P
White Flint North, 10A–12M, 11601 United States, as well as for these same
Landsdown St., North Bethesda, MD products that are not legally marketed
20852, 301–796–8867, PRAStaff@ but are acceptable to the importing
DEPARTMENT OF HEALTH AND fda.hhs.gov. country, as specified in sections 801(e)
HUMAN SERVICES SUPPLEMENTARY INFORMATION: In and 802 of the FD&C Act. FDA has
compliance with 44 U.S.C. 3507, FDA developed various types of certificates
Food and Drug Administration has submitted the following proposed that satisfy the requirements of section
[Docket No. FDA–2010–N–0161] collection of information to OMB for 801(e)(4)(B) of the FD&C Act. Four of
review and clearance. those certificates are discussed in this
Agency Information Collection notice: (1) Certificates to Foreign
Export of Food and Drug
Activities; Submission for Office of Governments, (2) Certificates of
Administration-Regulated Products:
Management and Budget Review; Exportability, (3) Certificates of a
Export Certificates
Comment Request; Export of Food and Pharmaceutical Product, and (4) Non-
Drug Administration-Regulated OMB Control Number 0910–0498— Clinical Research Use Only Certificates.
Products: Export Certificates Extension FDA has updated the certificates as part
AGENCY: Food and Drug Administration, In April 1996, the FDA Export, of the proposed collection of
HHS. Reform, and Enhancement Act of 1996 information to account for the
ACTION: Notice. (FDAERA) (Pub. L. 104–134) amended amendment authorizing export
sections 801(e) and 802 of the Federal certification fees for food and animal
SUMMARY: The Food and Drug Food, Drug, and Cosmetic Act (FD&C feed. Table 1 lists the different
Administration (FDA) is announcing Act) (21 U.S.C. 381(e) and 382). It was certificates and details their uses:
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 Foreign Government
(For Human Tissue Intended for Transplantation)’’.
‘‘Supplementary Information Certificate of Exportability Requests’’ ........ For the export of products not approved for marketing in the United
‘‘Exporter’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-
sradovich on DSK3GMQ082PROD with NOTICES
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’’. component that is not intended for human use which may be mar-
‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’ keted in, and legally exported from the United States under the
FD&C Act.
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![7196 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
FDA will continue to rely on self- center, but also at the time that they In the Federal Register of November
certification by manufacturers for the submit the certification to the foreign 27, 2017 (82 FR 56031), FDA published
first three types of certificates listed in government. a 60-day notice requesting public
table 1. Manufacturers are requested to The appropriate FDA centers will comment on the proposed collection of
self-certify that they are in compliance review product information submitted information. No comments were
with all applicable requirements of the by firms in support of their certificate received. The burden hours have
FD&C Act, not only at the time that they and any suspected case of fraud will be decreased from the previous approval.
submit their request to the appropriate referred to the appropriate offices.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses
FDA Center annual burden per Total hours
respondents per responses response
respondent
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 ............................................ 1,925 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.
Dated: February 13, 2018. during the regulatory review period by • If you want to submit a comment
Leslie Kux, August 20, 2018. See ‘‘Petitions’’ in the with confidential information that you
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for do not wish to be made available to the
[FR Doc. 2018–03346 Filed 2–16–18; 8:45 am] more information. public, submit the comment as a
BILLING CODE 4164–01–P ADDRESSES: You may submit comments written/paper submission and in the
as follows. Please note that late, manner detailed (see ‘‘Written/Paper
untimely filed comments will not be Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND considered. Electronic comments must Written/Paper Submissions
HUMAN SERVICES be submitted on or before April 23, Submit written/paper submissions as
2018. The https://www.regulations.gov follows:
Food and Drug Administration
electronic filing system will accept • Mail/Hand delivery/Courier (for
[Docket No. FDA–2016–E–1187] comments until midnight Eastern Time written/paper submissions): Dockets
at the end of April 23, 2018. Comments Management Staff (HFA–305), Food and
Determination of Regulatory Review received by mail/hand delivery/courier
Period for Purposes of Patent Drug Administration, 5630 Fishers
(for written/paper submissions) will be Lane, Rm. 1061, Rockville, MD 20852.
Extension; MAESTRO considered timely if they are
RECHARGEABLE SYSTEM • For written/paper comments
postmarked or the delivery service submitted to the Dockets Management
AGENCY: Food and Drug Administration, acceptance receipt is on or before that Staff, FDA will post your comment, as
HHS. date. well as any attachments, except for
ACTION: Notice. Electronic Submissions information submitted, marked and
identified, as confidential, if submitted
SUMMARY: The Food and Drug Submit electronic comments in the as detailed in ‘‘Instructions.’’
Administration (FDA or the Agency) has following way: Instructions: All submissions received
determined the regulatory review period • Federal eRulemaking Portal: must include the Docket No. FDA–
for MAESTRO RECHARGEABLE https://www.regulations.gov. Follow the 2016–E–1187 for ‘‘Determination of
SYSTEM and is publishing this notice instructions for submitting comments. Regulatory Review Period for Purposes
of that determination as required by Comments submitted electronically, of Patent Extension; MAESTRO
law. FDA has made the determination including attachments, to https:// RECHARGEABLE SYSTEM.’’ Received
because of the submission of an www.regulations.gov will be posted to comments, those filed in a timely
application to the Director of the U.S. the docket unchanged. Because your manner (see ADDRESSES), will be placed
Patent and Trademark Office (USPTO), comment will be made public, you are in the docket and, except for those
Department of Commerce, for the solely responsible for ensuring that your submitted as ‘‘Confidential
extension of a patent which claims that comment does not include any Submissions,’’ publicly viewable at
medical device. confidential information that you or a https://www.regulations.gov or at the
DATES: Anyone with knowledge that any third party may not wish to be posted, Dockets Management Staff between 9
of the dates as published (in the such as medical information, your or a.m. and 4 p.m., Monday through
SUPPLEMENTARY INFORMATION section) are anyone else’s Social Security number, or Friday.
sradovich on DSK3GMQ082PROD with NOTICES
incorrect may submit either electronic confidential business information, such • Confidential Submissions—To
or written comments and ask for a as a manufacturing process. Please note submit a comment with confidential
redetermination by April 23, 2018. that if you include your name, contact information that you do not wish to be
Furthermore, any interested person may information, or other information that made publicly available, submit your
petition FDA for a determination identifies you in the body of your comments only as a written/paper
regarding whether the applicant for comments, that information will be submission. You should submit two
extension acted with due diligence posted on https://www.regulations.gov. copies total. One copy will include the
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Document Created: 2018-02-17 02:29:50
Document Modified: 2018-02-17 02:29:50
| 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 | Fax written comments on the collection of information by March 22, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 7195 |
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