81 FR 30311 - Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 94 (May 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 94 (May 16, 2016)
| Page Range | 30311-30312 | |
| FR Document | 2016-11450 |
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)] [Notices] [Pages 30311-30312] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11450] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; 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 guidance entitled ``Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 [[Page 30312]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2011-D-0514 for ``Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of the Center Director, 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. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Nicole Jones, Associate Director Program Operations, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4108, Silver Spring, MD 20993-0002, 301-796-6062. SUPPLEMENTARY INFORMATION: I. Background Section 522 of the FD&C Act (21 U.S.C. 360l) provides FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices. This guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing an overview of section 522 of the FD&C Act, information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. FDA issued the draft of this guidance, originally entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies,'' on August 16, 2011 (76 FR 50740). The comment period ended on November 14, 2011. This document supersedes the guidance entitled, ``Guidance for Industry and FDA Staff; Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act,'' dated April 27, 2006. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on postmarket surveillance under section 522 of the FD&C Act. 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. III. Electronic Access Persons interested in obtaining a copy of the 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1754 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 822 have been approved under 0910-0449. Dated: May 10, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-11450 Filed 5-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices 30311
your requests. See the SUPPLEMENTARY received several comments from the DEPARTMENT OF HEALTH AND
INFORMATION section for electronic pharmaceutical industry and others. We HUMAN SERVICES
access to the guidance document. have carefully considered the comments
FOR FURTHER INFORMATION CONTACT: and have made the following changes in Food and Drug Administration
Elizabeth Hausner, Center for Drug response to the comments: (1) Changed [Docket No. FDA–2011–D–0514]
Evaluation and Research, Food and the title of the guidance to
Drug Administration, 10903 New ‘‘Considerations for Use of Postmarket Surveillance Under Section
Hampshire Ave., Bldg. 22, Rm. 4145, Histopathology and Its Associated 522 of the Federal Food, Drug, and
Silver Spring, MD 20993–0002, 301– Methodologies to Support Biomarker Cosmetic Act; Guidance for Industry
796–1084. Qualification’’; (2) clarified the scope of and Food and Drug Administration
SUPPLEMENTARY INFORMATION: the guidance; (3) added more Staff; Availability
I. Background information concerning data used to AGENCY: Food and Drug Administration,
support biomarker qualification; (4) HHS.
FDA is announcing the availability of confirmed and clarified the rationale for ACTION: Notice of availability.
a guidance for industry entitled assessment of outcomes without
‘‘Considerations for Use of knowledge of group assignments in SUMMARY: The Food and Drug
Histopathology and Its Associated confirmatory studies; and (5) clarified Administration (FDA or Agency) is
Methodologies to Support Biomarker the distinction between biomarker announcing the availability of the
Qualification.’’ The FDA Critical Path guidance entitled ‘‘Postmarket
sensitivity and specificity. In addition
Initiative identified the discovery, Surveillance Under Section 522 of the
we have made editorial changes to
characterization, qualification, and use Federal Food, Drug, and Cosmetic Act.’’
of biomarkers as important for improve clarity. This guidance finalizes
This guidance is intended to assist
improving the efficiency and success the draft guidance issued in December
manufacturers of devices subject to
rate of medical product development. 2011. section 522 postmarket surveillance
Biomarkers have been broadly applied This guidance is being issued orders by providing an overview of the
to describe the following: consistent with FDA’s good guidance Federal Food, Drug, and Cosmetic Act
• Structural features from the practices regulation (21 CFR 10.115). (the FD&C Act), information on how to
molecular to the anatomic level (e.g., The guidance represents the current fulfill section 522 obligations, and
genetic composition, receptor thinking of FDA on considerations for recommendations on the format,
expression patterns, radiographic the use of histopathology and its content, and review of postmarket
appearances); associated methodologies to support surveillance plan submissions.
• Biochemical measurements (e.g., biomarker qualification. It does not DATES: Submit either electronic or
serum levels of electrolytes, cardiac establish any rights for any person and written comments on this guidance at
troponins); and is not binding on FDA or the public. any time. General comments on Agency
• Physiologic organ system function You can use an alternative approach if guidance documents are welcome at any
tests (e.g., creatinine clearance, it satisfies the requirements of the time.
pulmonary function tests, cardiac ADDRESSES: You may submit comments
applicable statutes and regulations.
ejection fraction, electrocardiography). as follows:
The type of study reports to be II. Paperwork Reduction Act of 1995
submitted in support of a biomarker Electronic Submissions
qualification will depend upon the This guidance contains information Submit electronic comments in the
proposed context of use and the collection provisions that are subject to following way:
ultimate goal of the submission. The review by the Office of Management and • Federal eRulemaking Portal: http://
proposed context of use dictates the Budget (OMB) under the Paperwork www.regulations.gov. Follow the
depth, extent, and rigor of the Reduction Act of 1995 (44 U.S.C. 3501– instructions for submitting comments.
supporting data for the biomarker. If a 3520). The collections of information in Comments submitted electronically,
biomarker becomes qualified, this guidance were approved under including attachments, to http://
analytically valid measurements of it OMB control numbers 0910–0001 for www.regulations.gov will be posted to
can be relied upon to have a specific submissions related to 21 CFR 314, and the docket unchanged. Because your
and interpretable meaning (e.g., 0910–0014 for submissions related to 21 comment will be made public, you are
physiologic, toxicologic, pharmacologic, CFR 312. solely responsible for ensuring that your
or clinical) in drug development and comment does not include any
regulatory decision-making. Industry III. Electronic Access confidential information that you or a
can then employ the biomarker for the third party may not wish to be posted,
Persons with access to the Internet
qualified context of use during such as medical information, your or
may obtain the document at either
premarketing drug development, and anyone else’s Social Security number, or
FDA reviewers can be confident about http://www.fda.gov/Drugs/Guidance
confidential business information, such
its qualified context of use without the ComplianceRegulatoryInformation/
as a manufacturing process. Please note
need to reconfirm its applicability or Guidances/default.htm or http:// that if you include your name, contact
utility. Accordingly, data supporting www.regulations.gov. information, or other information that
asabaliauskas on DSK3SPTVN1PROD with NOTICES
qualification of a nonclinical biomarker Dated: May 10, 2016. identifies you in the body of your
should be reliable, repeatable, and of Leslie Kux, comments, that information will be
assured integrity. Associate Commissioner for Policy. posted on http://www.regulations.gov.
In the Federal Register of December • If you want to submit a comment
[FR Doc. 2016–11438 Filed 5–13–16; 8:45 am]
30, 2011 (76 FR 82306), FDA announced with confidential information that you
the availability of a draft guidance BILLING CODE 4164–01–P do not wish to be made available to the
entitled ‘‘Use of Histology in Biomarker public, submit the comment as a
Qualification Studies.’’ The Agency written/paper submission and in the
VerDate Sep<11>2014 18:48 May 13, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1](https://thefederalregister.org/doc/81_FR_30405/page/1.svg)
![30312 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Notices
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to practices regulation (21 CFR 10.115).
Submissions’’ and ‘‘Instructions’’). read background documents or the The guidance represents the current
electronic and written/paper comments thinking of FDA on postmarket
Written/Paper Submissions
received, go to http:// surveillance under section 522 of the
Submit written/paper submissions as www.regulations.gov and insert the FD&C Act. It does not establish any
follows: docket number, found in brackets in the rights for any person and is not binding
• Mail/Hand delivery/Courier (for heading of this document, into the on FDA or the public. You can use an
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts alternative approach if it satisfies the
Dockets Management (HFA–305), Food and/or go to the Division of Dockets requirements of the applicable statutes
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. and regulations.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single III. Electronic Access
submitted to the Division of Dockets copies of the guidance to the Office of Persons interested in obtaining a copy
Management, FDA will post your the Center Director, Guidance and of the guidance may do so by
comment, as well as any attachments, Policy Development, Center for Devices downloading an electronic copy from
except for information submitted, and Radiological Health, Food and Drug the Internet. A search capability for all
marked and identified, as confidential, Administration, 10903 New Hampshire Center for Devices and Radiological
if submitted as detailed in Ave., Bldg. 66, Rm. 5431, Silver Spring, Health guidance documents is available
‘‘Instructions.’’ MD 20993–0002. Send one self- at http://www.fda.gov/MedicalDevices/
Instructions: All submissions received addressed adhesive label to assist that DeviceRegulationandGuidance/
must include the Docket No. FDA– office in processing your request. The GuidanceDocuments/default.htm.
2011–D–0514 for ‘‘Postmarket guidance may also be obtained by mail Guidance documents are also available
Surveillance Under Section 522 of the by calling CBER at 1–800–835–4709 or at http://www.regulations.gov. Persons
Federal Food, Drug, and Cosmetic Act.’’ 240–402–8010. See the SUPPLEMENTARY unable to download an electronic copy
Received comments will be placed in INFORMATION section for information on of ‘‘Postmarket Surveillance Under
the docket and, except for those electronic access to the guidance. Section 522 of the Federal Food, Drug,
submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: and Cosmetic Act’’ may send an email
Submissions,’’ publicly viewable at Nicole Jones, Associate Director
http://www.regulations.gov or at the request to CDRH-Guidance@fda.hhs.gov
Program Operations, Center for Devices to receive an electronic copy of the
Division of Dockets Management and Radiological Health, Food and Drug
between 9 a.m. and 4 p.m., Monday document. Please use the document
Administration, 10903 New Hampshire number 1754 to identify the guidance
through Friday. Ave., Bldg. 66, Rm. 4108, Silver Spring,
• Confidential Submissions—To you are requesting.
MD 20993–0002, 301–796–6062.
submit a comment with confidential IV. Paperwork Reduction Act of 1995
information that you do not wish to be SUPPLEMENTARY INFORMATION:
made publicly available, submit your This guidance refers to previously
I. Background
comments only as a written/paper approved collections of information
Section 522 of the FD&C Act (21 found in FDA regulations. These
submission. You should submit two
U.S.C. 360l) provides FDA with the collections of information are subject to
copies total. One copy will include the authority to require manufacturers to
information you claim to be confidential review by the Office of Management and
conduct postmarket surveillance of Budget (OMB) under the Paperwork
with a heading or cover note that states certain class II or class III devices. This
‘‘THIS DOCUMENT CONTAINS Reduction Act of 1995 (44 U.S.C. 3501–
guidance is intended to assist 3520). The collections of information in
CONFIDENTIAL INFORMATION.’’ The manufacturers of devices subject to
Agency will review this copy, including 21 CFR part 822 have been approved
section 522 postmarket surveillance under 0910–0449.
the claimed confidential information, in orders by providing an overview of
its consideration of comments. The Dated: May 10, 2016.
section 522 of the FD&C Act,
second copy, which will have the information on how to fulfill section Leslie Kux,
claimed confidential information 522 obligations, and recommendations Associate Commissioner for Policy.
redacted/blacked out, will be available on the format, content, and review of [FR Doc. 2016–11450 Filed 5–13–16; 8:45 am]
for public viewing and posted on http:// postmarket surveillance plan BILLING CODE 4164–01–P
www.regulations.gov. Submit both submissions.
copies to the Division of Dockets FDA issued the draft of this guidance,
Management. If you do not wish your originally entitled ‘‘Draft Guidance for DEPARTMENT OF HEALTH AND
name and contact information to be Industry and Food and Drug HUMAN SERVICES
made publicly available, you can Administration Staff; Procedures for
provide this information on the cover Handling Section 522 Postmarket Food and Drug Administration
sheet and not in the body of your Surveillance Studies,’’ on August 16,
comments and you must identify this [Docket No. FDA–2012–N–1203]
2011 (76 FR 50740). The comment
information as ‘‘confidential.’’ Any period ended on November 14, 2011. Agency Information Collection
information marked as ‘‘confidential’’ This document supersedes the Activities; Submission for Office of
will not be disclosed except in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance entitled, ‘‘Guidance for Management and Budget Review;
accordance with 21 CFR 10.20 and other Industry and FDA Staff; Postmarket Comment Request; Information To
applicable disclosure law. For more Surveillance under Section 522 of the Accompany Humanitarian Device
information about FDA’s posting of Federal Food, Drug, and Cosmetic Act,’’ Exemption Applications and Annual
comments to public dockets, see 80 FR dated April 27, 2006. Distribution Number Reporting
56469, September 18, 2015, or access Requirements
the information at: http://www.fda.gov/ II. Significance of Guidance
regulatoryinformation/dockets/ This guidance is being issued AGENCY: Food and Drug Administration,
default.htm. consistent with FDA’s good guidance HHS.
VerDate Sep<11>2014 18:48 May 13, 2016 Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1](https://thefederalregister.org/doc/81_FR_30405/page/2.svg)
Document Created: 2016-05-14 01:17:24
Document Modified: 2016-05-14 01:17:24
| 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 of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Nicole Jones, Associate Director Program Operations, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4108, Silver Spring, MD 20993-0002, 301-796-6062. | |
| FR Citation | 81 FR 30311 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR