Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 46740-46742 [2018-19993]
Download as PDF
<![CDATA[
46740
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
Topic
807, subpart E and Form FDA 3654 ..............................................................
814, subparts A through E .............................................................................
814, subpart H ................................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff‘‘.
820 ..................................................................................................................
Premarket Notification ............................................
Premarket Approval ...............................................
Humanitarian Device Exemption ............................
Q-Submissions .......................................................
0910–0120
0910–0231
0910–0332
0910–0756
Current Good Manufacturing Practice; Quality
System Regulation.
Investigational New Drug Regulation .....................
Biologics License Application .................................
0910–0073
312 ..................................................................................................................
601 ..................................................................................................................
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2018–19989 Filed 9–13–18; 8:45 am]
BILLING CODE 4164–01–P
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Voluntary Consensus Standards; Draft
Guidance for Industry and Food and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.
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announcing the availability of the draft
guidance entitled ‘‘Recognition and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 This draft guidance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.
SUMMARY:
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.
DATES:
daltland on DSKBBV9HB2PROD with NOTICES
OMB
control
No.
21 CFR part. guidance, or FDA form
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
0910–0014
0910–0338
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
E:\FR\FM\14SEN1.SGM
14SEN1
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
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:
daltland on DSKBBV9HB2PROD with NOTICES
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
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
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/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
46741
download an electronic copy of
‘‘Recognition and Withdrawal of
Voluntary Consensus Standards’’ may
send an email request to CDRHGuidance@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
E:\FR\FM\14SEN1.SGM
14SEN1
46742
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
• 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
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;
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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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_01-222016.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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2565]
510(k) Third-Party Review Program;
Draft Guidance for Industry, Food and
Drug Administration Staff, and ThirdParty Review Organizations;
Availability
daltland on DSKBBV9HB2PROD with NOTICES
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 ‘‘510(k) Third-Party
Review Program; Draft Guidance for
SUMMARY:
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
Industry, Food and Drug Administration
Staff, and Third-Party Review
Organizations.’’ This draft guidance
provides a comprehensive look into
FDA’s current thinking regarding the
510(k) Third-Party (3P) Review Program
authorized under the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
Under the FDA Reauthorization Act of
2017 (FDARA), FDA was directed to
issue draft guidance on the factors that
will be used in determining whether a
class I or class II device type, or subset
of such device types, is eligible for
review by an accredited person. The 3P
Review Program is intended to allow
review of devices by 3P Review
Organizations to provide manufacturers
of these devices an alternative review
process that allows FDA to best utilize
our resources on higher risk devices.
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 December 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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–
2016–D–2565 for ‘‘510(k) Third-Party
Review Program.’’ 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
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.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 [email protected] 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
