Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 28630-28631 [2021-11216]

Download as PDF 28630 Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices Dated: May 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–11217 Filed 5–26–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0027] Procedures for Handling PostApproval Studies Imposed by Premarket Approval Application Order; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.’’ The existing postapproval studies final guidance, entitled ‘‘Procedures for Handling Post-Approval Studies Imposed by PMA Order,’’ was issued in June 2009. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by July 26, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 17:29 May 26, 2021 Jkt 253001 confidential business information, such 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– 2005–D–0027 for ‘‘Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.’’ Received comments 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, 240–402–7500. • 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 Dockets Management Staff. 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 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 ‘‘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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Nilsa Loyo-Berrios, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G114, Silver Spring, MD 20993–0002, 301–796–6065. SUPPLEMENTARY INFORMATION: I. Background To provide reasonable assurance, or the continued assurance, of safety and effectiveness of an approved device, FDA may require a post-approval study (PAS) as a condition of approval under 21 CFR 814.82(a)(2) and (a)(9). A PAS is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device. As described in ‘‘Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval,’’ FDA may E:\FR\FM\27MYN1.SGM 27MYN1 Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices consider it acceptable to collect certain data in the postmarket setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device at the time of premarket approval. The purpose of this draft guidance document is to assist stakeholders with understanding PAS requirements imposed as a condition of a PMA by providing: • Procedural information; • recommendations concerning the format, content, and review of PASrelated submissions; and • updates to the final guidance entitled ‘‘Procedures for Handling PostApproval Studies Imposed by PMA Order’’ dated June 2009, including: Æ Recommendations to help facilitate FDA’s review of a PAS protocol in a timely manner; Æ recommendations for study timelines including enrollment milestones and study completion; Æ revised definitions to PAS status categories that we believe better reflect progress of the PAS; and www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19043 and complete title to identify the guidance you are requesting. II. Electronic Access While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance is also available at https:// www.regulations.gov and at https:// III. Paperwork Reduction Act of 1995 OMB control No. Topic 814, subparts A through E ....................... 814, subpart H .......................................... Premarket approval ...................................................................................................... Humanitarian use devices; Humanitarian device exemption ....................................... [FR Doc. 2021–11216 Filed 5–26–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for nominations. AGENCY: HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT or Committee). ACOT provides advice and recommendations to the Secretary of HHS (Secretary) on matters pertaining to SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Æ revised FDA review time goals for PAS-related submissions. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Procedures for Handling PostApproval Studies Imposed by Premarket Approval Application Order.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 21 CFR part Dated: May 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. VerDate Sep<11>2014 17:29 May 26, 2021 Jkt 253001 28631 organ donation, procurement, allocation, and transplantation; maximizing the number of deceased donor organs available for transplantation; supporting the safety of living organ donation proposed policies of the Organ Procurement and Transplantation Network (OPTN) and OPTN operations; and the latest advances in the science of transplantation. Authority: In accordance with 42 CFR 121.12, the Secretary established ACOT pursuant to 42 U.S.C. 217a. The Committee is governed by the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Written nominations for membership on the ACOT will be received on a continuous basis. ADDRESSES: Nomination packages must be submitted to the Executive Secretary, ACOT, Healthcare Systems Bureau, HRSA, Room 08W67, 5600 Fishers Lane, Rockville, Maryland 20857, or via email to: ACOTHRSA@hrsa.gov. FOR FURTHER INFORMATION CONTACT: Shelley Grant, Executive Secretary, ACOT, at (301) 443–8036 or email DATES: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 0910–0231 0910–0332 sgrant@hrsa.gov. A copy of the ACOT charter and list of current members may be obtained by accessing the ACOT website at https://www.organdonor.gov/ about-dot/acot.html. SUPPLEMENTARY INFORMATION: In accordance with the Amended Final Rule of the OPTN (42 CFR part 121), the ACOT was established pursuant to 42 U.S.C. 217a and, in accordance with Public Law 92–463, was first chartered on September 1, 2000. The ACOT meets up to three times during the fiscal year. Nominations: HRSA is requesting nominations for voting members to serve as Special Government Employees (SGEs) on ACOT. The Secretary appoints ACOT members with the expertise needed to fulfill the duties of the Advisory Committee. Nominees sought are individuals knowledgeable in such fields as deceased and living organ donation, health care public policy, transplantation medicine and surgery, critical care medicine, and other medical specialties involved in the identification and referral of donors, non-physician transplant professions, nursing, epidemiology, immunology, law and bioethics, behavioral sciences, E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28630-28631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11216]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0027]

Procedures for Handling Post-Approval Studies Imposed by
Premarket Approval Application Order; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Procedures for
Handling Post-Approval Studies Imposed by Premarket Approval
Application Order.'' The existing post-approval studies final guidance,
entitled ``Procedures for Handling Post-Approval Studies Imposed by PMA
Order,'' was issued in June 2009. This draft guidance is intended to
update the 2009 guidance to assist stakeholders with understanding
post-approval study requirements imposed as a condition of approval of
a premarket approval application (PMA). This draft guidance is not
final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by July 26, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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 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-2005-D-0027 for ``Procedures for Handling Post-Approval Studies
Imposed by Premarket Approval Application Order.'' Received comments
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, 240-402-7500.
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 Dockets Management Staff. 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.govinfo.gov/content/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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Procedures for Handling Post-Approval Studies Imposed by Premarket
Approval Application Order'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Nilsa Loyo-Berrios, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G114, Silver Spring, MD 20993-0002, 301-
796-6065.

SUPPLEMENTARY INFORMATION:

I. Background

To provide reasonable assurance, or the continued assurance, of
safety and effectiveness of an approved device, FDA may require a post-
approval study (PAS) as a condition of approval under 21 CFR
814.82(a)(2) and (a)(9). A PAS is usually a clinical or non-clinical
study, as specified in the PMA approval order, and is typically
intended to gather specific data to address questions about the
postmarket performance of or experience with an approved medical
device. As described in ``Balancing Premarket and Postmarket Data
Collection for Devices Subject to Premarket Approval,'' FDA may

[[Page 28631]]

consider it acceptable to collect certain data in the postmarket
setting, rather than premarket under certain circumstances when FDA has
uncertainty regarding certain benefits or risks of the device, but the
degree of uncertainty is acceptable in the context of the overall
benefit-risk profile of the device at the time of premarket approval.
The purpose of this draft guidance document is to assist stakeholders
with understanding PAS requirements imposed as a condition of a PMA by
providing:
Procedural information;
recommendations concerning the format, content, and review
of PAS-related submissions; and
updates to the final guidance entitled ``Procedures for
Handling Post-Approval Studies Imposed by PMA Order'' dated June 2009,
including:
[cir] Recommendations to help facilitate FDA's review of a PAS
protocol in a timely manner;
[cir] recommendations for study timelines including enrollment
milestones and study completion;
[cir] revised definitions to PAS status categories that we believe
better reflect progress of the PAS; and
[cir] revised FDA review time goals for PAS-related submissions.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Procedures
for Handling Post-Approval Studies Imposed by Premarket Approval
Application Order.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Procedures for Handling Post-Approval
Studies Imposed by Premarket Approval Application Order'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 19043 and complete
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:

------------------------------------------------------------------------
OMB control
21 CFR part Topic No.
------------------------------------------------------------------------
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian use 0910-0332
devices; Humanitarian
device exemption.
------------------------------------------------------------------------

Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11216 Filed 5-26-21; 8:45 am]
BILLING CODE 4164-01-P

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