[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46740-46742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19993]


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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Draft Guidance for Industry and Food and Drug Administration Staff; 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.

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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announcing the availability of the draft guidance entitled 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draft guidance identifies the principles FDA uses for recognizing a 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 This draft guidance also responds to a provision 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 This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by November 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.gpo.gov/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 <a href="/cdn-cgi/l/email-protection#682b2c3a20452f1d010c09060b0d280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="430007110b6e04362a27222d2026032527226d2b2b306d242c35">[email protected]</span></a> 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:
    <bullet> Name and electronic or mailing address of the requestor;
    <bullet> Title of the standard;
    <bullet> Any reference number and date;
    <bullet> Proposed list of devices for which a declaration of 
conformity should routinely apply;
    <bullet> Basis for recognition, e.g., including the scientific, 
technical, regulatory, or other basis for such request; and
    <bullet> 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\
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                                                                                         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


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