83 FR 46740 - Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 179 (September 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 179 (September 14, 2018)
| Page Range | 46740-46742 | |
| FR Document | 2018-19993 |
[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)] [Notices] [Pages 46740-46742] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19993] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2936] Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Recognition and Withdrawal of Voluntary Consensus Standards.'' This draft guidance identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how you may request recognition as well as circumstances under which FDA may withdraw recognition. This draft guidance also responds to a provision of the 21st Century Cures Act (Cures Act) by updating published guidance on these topics. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by November 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments on the collection of information by November 13, 2018. 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-2018-D-2936 for ``Recognition and Withdrawal of Voluntary Consensus Standards.'' 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. 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.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. [[Page 46741]] 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 ``Recognition and Withdrawal of Voluntary Consensus Standards'' 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 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA's standards recognition program furthers the aim of international harmonization because the same standards (or international equivalents) are relied upon by sponsors to meet other countries' regulatory requirements when appropriate. This draft guidance describes the procedures that FDA follows and the actions FDA may take during its review and evaluation of requests for standards recognition or the withdrawal of recognition. This draft guidance provides further clarity and explanation about the regulatory framework, policies, and practices when evaluating requests for recognition. This draft guidance also responds to section 3053 of the Cures Act by updating published guidance on these topics (Pub. L. 114- 255). When final, this draft guidance will supersede the guidance ``CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition,'' issued on September 17, 2007. FDA generally considers for recognition voluntary consensus standards, which are created by standards development organizations that follow a consensus process. A document issued by the Office of Management and Budget (OMB) entitled ``Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities,'' commonly called OMB Circular A-119, defines the attributes or elements of a consensus process (Ref. 1). This draft guidance explains those elements and how they pertain to FDA's consideration of a standard for recognition. The draft guidance describes the process leading up to and including recognition. We list common purposes to recognize voluntary consensus standards as well as the essential information that FDA will provide in the supplemental information sheet for the recognition of a standard. This draft guidance also discusses when FDA may withdraw recognition. You may also request that FDA recognize a specific voluntary consensus standard. This draft guidance recommends the information you would submit to do so, and it summarizes the actions we may take to act on such a request. II. Significance of Guidance 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 recognition and withdrawal of voluntary consensus standards. 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. This guidance is not subject to Executive Order 12866. III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Recognition and Withdrawal of Voluntary Consensus Standards'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 616 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the 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 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. Request for Recognition of a Voluntary Consensus Standard OMB Control Number 0910--NEW The draft guidance for industry and FDA staff entitled ``Recognition and Withdrawal of Voluntary Consensus Standards'' provides guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health follows when a request for recognition of a voluntary consensus standard is received. The guidance outlines justifications for why a standard may be recognized wholly, partly, or not at all, as well as reasons [[Page 46742]] and rationales for withdrawing a standard. The guidance also provides that any interested party may request recognition of a standard. The draft guidance recommends that for recognition of a standard the request should, at a minimum, contain the following information: Name and electronic or mailing address of the requestor; Title of the standard; Any reference number and date; Proposed list of devices for which a declaration of conformity should routinely apply; Basis for recognition, e.g., including the scientific, technical, regulatory, or other basis for such request; and A brief identification of the testing or performance or other characteristics of the device(s) or process(es), that would be addressed by a declaration of conformity. Based on previous requests for recognition of standards, we estimate that FDA will receive nine requests annually. We estimate that each request will take less than 1 hour to prepare. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Request for recognition of a voluntary consensus standard.......... 9 1 9 1 9 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. V. Reference The following reference is on display with the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. OMB, ``Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities,'' Circular A-119 (revised). January 22, 2016. Available at: https://www.nist.gov/sites/default/files/revised_circular_a-119_as_of_01-22-2016.pdf. Dated: September 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19993 Filed 9-13-18; 8:45 am] BILLING CODE 4164-01-P
![46740 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
OMB
21 CFR part. guidance, or FDA form Topic control
No.
807, subpart E and Form FDA 3654 .............................................................. Premarket Notification ............................................ 0910–0120
814, subparts A through E ............................................................................. Premarket Approval ............................................... 0910–0231
814, subpart H ................................................................................................ Humanitarian Device Exemption ............................ 0910–0332
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submis- Q-Submissions ....................................................... 0910–0756
sion Program and Meetings with Food and Drug Administration Staff‘‘.
820 .................................................................................................................. Current Good Manufacturing Practice; Quality 0910–0073
System Regulation.
312 .................................................................................................................. Investigational New Drug Regulation ..................... 0910–0014
601 .................................................................................................................. Biologics License Application ................................. 0910–0338
Dated: September 10, 2018. Electronic Submissions Submissions,’’ publicly viewable at
Leslie Kux, Submit electronic comments in the https://www.regulations.gov or at the
Associate Commissioner for Policy. following way: Dockets Management Staff between 9
[FR Doc. 2018–19989 Filed 9–13–18; 8:45 am] • Federal eRulemaking Portal: a.m. and 4 p.m., Monday through
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the Friday.
instructions for submitting comments. • Confidential Submissions—To
Comments submitted electronically, submit a comment with confidential
DEPARTMENT OF HEALTH AND including attachments, to https:// information that you do not wish to be
HUMAN SERVICES www.regulations.gov will be posted to made publicly available, submit your
the docket unchanged. Because your comments only as a written/paper
Food and Drug Administration comment will be made public, you are submission. You should submit two
solely responsible for ensuring that your copies total. One copy will include the
[Docket No. FDA–2018–D–2936] comment does not include any information you claim to be confidential
confidential information that you or a with a heading or cover note that states
Recognition and Withdrawal of third party may not wish to be posted,
Voluntary Consensus Standards; Draft ‘‘THIS DOCUMENT CONTAINS
such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
Guidance for Industry and Food and anyone else’s Social Security number, or
Drug Administration Staff; Availability Agency will review this copy, including
confidential business information, such
the claimed confidential information, in
as a manufacturing process. Please note
AGENCY: Food and Drug Administration, its consideration of comments. The
that if you include your name, contact
HHS. second copy, which will have the
information, or other information that
ACTION: Notice of availability. identifies you in the body of your claimed confidential information
comments, that information will be redacted/blacked out, will be available
SUMMARY: The Food and Drug posted on https://www.regulations.gov. for public viewing and posted on
Administration (FDA, Agency, or we) is • If you want to submit a comment https://www.regulations.gov. Submit
announcing the availability of the draft with confidential information that you both copies to the Dockets Management
guidance entitled ‘‘Recognition and do not wish to be made available to the Staff. If you do not wish your name and
Withdrawal of Voluntary Consensus public, submit the comment as a contact information to be made publicly
Standards.’’ This draft guidance written/paper submission and in the available, you can provide this
identifies the principles FDA uses for manner detailed (see ‘‘Written/Paper information on the cover sheet and not
recognizing a standard, and it explains Submissions’’ and ‘‘Instructions’’). in the body of your comments and you
the extent of recognition and other must identify this information as
supplementary information. It provides Written/Paper Submissions ‘‘confidential.’’ Any information marked
information on how you may request Submit written/paper submissions as as ‘‘confidential’’ will not be disclosed
recognition as well as circumstances follows: except in accordance with 21 CFR 10.20
under which FDA may withdraw • Mail/Hand Delivery/Courier (for and other applicable disclosure law. For
recognition. This draft guidance also written/paper submissions): Dockets more information about FDA’s posting
responds to a provision of the 21st Management Staff (HFA–305), Food and of comments to public dockets, see 80
Century Cures Act (Cures Act) by Drug Administration, 5630 Fishers FR 56469, September 18, 2015, or access
updating published guidance on these Lane, Rm. 1061, Rockville, MD 20852. the information at: https://www.gpo.gov/
topics. This draft guidance is not final • For written/paper comments fdsys/pkg/FR-2015-09-18/pdf/2015-
nor is it in effect at this time. submitted to the Dockets Management 23389.pdf.
Staff, FDA will post your comment, as
DATES: Submit either electronic or Docket: For access to the docket to
well as any attachments, except for
written comments on the draft guidance read background documents or the
information submitted, marked and
by November 13, 2018 to ensure that the electronic and written/paper comments
identified, as confidential, if submitted
Agency considers your comment on this received, go to https://
as detailed in ‘‘Instructions.’’
daltland on DSKBBV9HB2PROD with NOTICES
draft guidance before it begins work on Instructions: All submissions received www.regulations.gov and insert the
the final version of the guidance. must include the Docket No. FDA– docket number, found in brackets in the
Submit either electronic or written 2018–D–2936 for ‘‘Recognition and heading of this document, into the
comments on the collection of Withdrawal of Voluntary Consensus ‘‘Search’’ box and follow the prompts
information by November 13, 2018. Standards.’’ Received comments will be and/or go to the Dockets Management
ADDRESSES: You may submit comments placed in the docket and, except for Staff, 5630 Fishers Lane, Rm. 1061,
on any guidance at any time as follows: those submitted as ‘‘Confidential Rockville, MD 20852.
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![46742 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
and rationales for withdrawing a • Title of the standard; of the device(s) or process(es), that
standard. The guidance also provides • Any reference number and date; would be addressed by a declaration of
that any interested party may request • Proposed list of devices for which conformity.
recognition of a standard. The draft a declaration of conformity should Based on previous requests for
guidance recommends that for routinely apply; recognition of standards, we estimate
recognition of a standard the request • Basis for recognition, e.g., including that FDA will receive nine requests
should, at a minimum, contain the the scientific, technical, regulatory, or annually. We estimate that each request
following information: other basis for such request; and will take less than 1 hour to prepare.
• Name and electronic or mailing • A brief identification of the testing FDA estimates the burden of this
address of the requestor; or performance or other characteristics collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Request for recognition of a voluntary consensus standard 9 1 9 1 9
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
V. Reference Industry, Food and Drug Administration confidential information that you or a
The following reference is on display Staff, and Third-Party Review third party may not wish to be posted,
with the Dockets Management Staff (see Organizations.’’ This draft guidance such as medical information, your or
ADDRESSES) and is available for viewing
provides a comprehensive look into anyone else’s Social Security number, or
by interested persons between 9 a.m. FDA’s current thinking regarding the confidential business information, such
and 4 p.m., Monday through Friday; it 510(k) Third-Party (3P) Review Program as a manufacturing process. Please note
is also available electronically at https:// authorized under the Federal Food, that if you include your name, contact
www.regulations.gov. FDA has verified Drug, and Cosmetic Act (FD&C Act). information, or other information that
the website address, as of the date this Under the FDA Reauthorization Act of identifies you in the body of your
document publishes in the Federal 2017 (FDARA), FDA was directed to comments, that information will be
Register, but websites are subject to issue draft guidance on the factors that posted on https://www.regulations.gov.
change over time. will be used in determining whether a • If you want to submit a comment
class I or class II device type, or subset with confidential information that you
1. OMB, ‘‘Federal Participation in the
Development and Use of Voluntary
of such device types, is eligible for do not wish to be made available to the
Consensus Standards and in Conformity review by an accredited person. The 3P public, submit the comment as a
Assessment Activities,’’ Circular A–119 Review Program is intended to allow written/paper submission and in the
(revised). January 22, 2016. Available at: review of devices by 3P Review manner detailed (see ‘‘Written/Paper
https://www.nist.gov/sites/default/files/ Organizations to provide manufacturers Submissions’’ and ‘‘Instructions’’).
revised_circular_a-119_as_of_01-22- of these devices an alternative review
2016.pdf. Written/Paper Submissions
process that allows FDA to best utilize
Dated: September 10, 2018. our resources on higher risk devices. Submit written/paper submissions as
Leslie Kux, This draft guidance is not final nor is it follows:
Associate Commissioner for Policy. in effect at this time. • Mail/Hand Delivery/Courier (for
DATES: Submit either electronic or written/paper submissions): Dockets
[FR Doc. 2018–19993 Filed 9–13–18; 8:45 am]
written comments on the draft guidance Management Staff (HFA–305), Food and
BILLING CODE 4164–01–P
by December 13, 2018 to ensure that the Drug Administration, 5630 Fishers
Agency considers your comment on this Lane, Rm. 1061, Rockville, MD 20852.
DEPARTMENT OF HEALTH AND draft guidance before it begins work on • For written/paper comments
HUMAN SERVICES the final version of the guidance. submitted to the Dockets Management
Submit either electronic or written Staff, FDA will post your comment, as
Food and Drug Administration comments on the collection of well as any attachments, except for
information by November 13, 2018. information submitted, marked and
[Docket No. FDA–2016–D–2565] identified, as confidential, if submitted
ADDRESSES: You may submit comments
on any guidance at any time as follows: as detailed in ‘‘Instructions.’’
510(k) Third-Party Review Program;
Instructions: All submissions received
Draft Guidance for Industry, Food and Electronic Submissions must include the Docket No. FDA–
Drug Administration Staff, and Third-
Submit electronic comments in the 2016–D–2565 for ‘‘510(k) Third-Party
Party Review Organizations;
following way: Review Program.’’ Received comments
Availability
• Federal eRulemaking Portal: will be placed in the docket and, except
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the for those submitted as ‘‘Confidential
HHS. instructions for submitting comments. Submissions,’’ publicly viewable at
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice of availability. Comments submitted electronically, https://www.regulations.gov or at the
including attachments, to https:// Dockets Management Staff between 9
SUMMARY: The Food and Drug www.regulations.gov will be posted to a.m. and 4 p.m., Monday through
Administration (FDA or Agency) is the docket unchanged. Because your Friday.
announcing the availability of the draft comment will be made public, you are • Confidential Submissions—To
guidance entitled ‘‘510(k) Third-Party solely responsible for ensuring that your submit a comment with confidential
Review Program; Draft Guidance for comment does not include any information that you do not wish to be
VerDate Sep<11>2014 17:06 Sep 13, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1](https://thefederalregister.org/doc/83_FR_46919/page/3.svg)
Document Created: 2018-09-14 03:02:54
Document Modified: 2018-09-14 03:02:54
| 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 the draft guidance by November 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments on the collection of information by November 13, 2018. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 46740 |
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