Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 60204-60206 [2017-27275]
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
revised burden estimates for the
proposed changes and solicited public
comment. In response to requests, the
comment period was extended to
January 21, 2017 (81 FR 75351, October
31, 2016). In the interim, FDA is seeking
an extension of OMB approval for the
In the Federal Register of April 25,
2017 (82 FR 19054), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received no comments.
FDA estimates the burden of this
collection of information as follows:
current regulations so that we can
continue to collect information while
the proposal is pending.
Description of Respondents: The
likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
58.35(b)(7); Quality assurance unit .....................................
58.185; Reporting of nonclinical laboratory study results ...
300
300
60.25
60.25
18,075
18,075
1
27.65
18,075
499,774
Total ..............................................................................
........................
........................
........................
........................
517,849
1 There
are no capital costs or operating maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
(in hours)
Total hours
58.29(b); Personnel .................................................
58.35(b)(1)–(6), and (c); Quality assurance unit .....
58.63(b) and (c); Maintenance and calibration of
equipment.
58.81(a)–(c); SOPs ..................................................
58.90(c) and (g); Animal care ..................................
58.105(a) and (b); Test and control article characterization.
58.107(d); Test and control article handling ............
58.113(a); Mixtures of articles with carriers ............
58.120; Protocol .......................................................
58.195; Retention of records ...................................
300
300
300
20
270.76
60
6,000
81,228
18,000
.21 (13 minutes) ........
3.36 ...........................
.09 (5 minutes) ..........
1,260
272,926
1,620
300
300
300
301.8
62.7
5
90,540
18,810
1,500
.14 (8 minutes) ..........
.13 (8 minutes) ..........
11.8 ...........................
12,676
2,445
17,700
300
300
300
300
1
15.33
15.38
251.5
300
4,599
4,614
75,450
4.25 ...........................
6.8 .............................
32.7 ...........................
3.9 .............................
1,275
31,273
150,878
294,255
Total ..................................................................
........................
........................
........................
....................................
786,308
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the
information collection requirements in
these regulations is estimated at
1,304,157 burden hours (517,849 +
786,308 = 1,304,157). The hours per
response estimates are based on our
experience with similar programs and
information received from industry.
Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27255 Filed 12–18–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6535]
Standards Development and the Use of
Standards in Regulatory Submissions
Reviewed in the Center for Biologics
Evaluation and Research; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ The draft guidance document
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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recognizes the value of standards and
encourages the use of appropriate
standards to facilitate the evaluation of
products regulated by the Center for
Biologics Evaluation and Research
(CBER). The guidance describes CBER’s
recommendations on the use of
standards in product development and
the use of such standards in CBER’s
managed review process. The draft
guidance does not endorse the activities
of specific Standards Development
Organizations or recommend specific
standards for use in regulatory
submissions.
DATES: Submit either electronic or
written comments on the draft guidance
by March 19, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
• 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–
2017–D–6535 for ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ 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
VerDate Sep<11>2014
17:47 Dec 18, 2017
Jkt 244001
‘‘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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to 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 the office in processing your
requests. The draft 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 electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Angela Moy, 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 is announcing the availability of
a draft document entitled ‘‘Standards
PO 00000
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60205
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ The Federal Government’s
policies on the use of standards
developed by voluntary consensus
standard bodies are described in the
Office of Management and Budget
Circular A–119, ‘‘Federal Participation
in the Development and Use of
Voluntary Consensus Standards and in
Conformity Assessment Activities.’’ The
policies outlined in Circular A–119
were codified in the National
Technology Transfer and Advancement
Act of 1995 (NTTAA). The NTTAA
authorizes the National Institute of
Standards and Technology to coordinate
standards activities for Federal
Agencies.
CBER recognizes the value of
standards and encourages the use of
appropriate standards in the
development of CBER-regulated medical
products. Sponsors’ use of standards
can facilitate product development and
a more efficient evaluation of regulatory
submissions. The draft guidance
describes CBER’s recommendations on
the use of standards in product
development and the use of such
standards in CBER’s managed review
process. It describes how standards are
developed, the benefits of using
standards, and CBER’s policy on
accepting standards used in regulatory
submissions. CBER’s use of, and CBER’s
acceptance of sponsors’ use of,
voluntary consensus standards do not
constitute a delegation of CBER’s
regulatory responsibilities. Whether or
not standards are used, CBER retains the
ability to set, and the responsibility for
setting, appropriate regulatory criteria
for CBER-regulated products.
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 standards development and the use
of standards in regulatory submissions
reviewed in CBER. 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.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
E:\FR\FM\19DEN1.SGM
19DEN1
60206
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
default.htm or https://
www.regulations.gov.
Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27275 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4678]
Modified Risk Tobacco Product
Applications: Applications for Six
Camel Snus Smokeless Tobacco
Products Submitted by R.J. Reynolds
Tobacco Company; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability for public
comment of modified risk tobacco
product applications (MRTPAs) for six
Camel Snus smokeless tobacco products
submitted by R.J. Reynolds Tobacco Co.
DATES: Electronic or written comments
on the applications may be submitted
until June 18, 2018; however, FDA may
modify the comment period by
providing notice as described in section
I.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:47 Dec 18, 2017
Jkt 244001
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–
2017–N–4678 for ‘‘Modified Risk
Tobacco Product Applications:
Applications for Six Camel Snus
Smokeless Tobacco Products Submitted
by R.J. Reynolds Tobacco Company.’’
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/
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read 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.
FOR FURTHER INFORMATION CONTACT: Paul
Hart, Center for Tobacco Products, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993–0002, 1–877–
287–1373, email: AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 911 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
387k) addresses the marketing and
distribution of modified risk tobacco
products (MRTPs). MRTPs are tobacco
products that are sold or distributed for
use to reduce harm or the risk of
tobacco-related disease associated with
commercially marketed tobacco
products. Section 911(a) of the FD&C
Act prohibits the introduction or
delivery for introduction into interstate
commerce of any MRTP unless an order
issued by FDA under section 911(g) of
the FD&C Act is effective with respect
to such product.
Section 911(d) of the FD&C Act
describes the information that must be
included in an MRTPA, which must be
filed and evaluated by FDA before an
applicant can receive an order from
FDA. FDA is required by section 911(e)
of the FD&C Act to make an MRTPA
available to the public (except for
matters in the application that are trade
secrets or otherwise confidential
commercial information) and to request
comments by interested persons on the
information contained in the
application and on the label, labeling,
and advertising accompanying the
application. The determination of
whether an order is appropriate under
section 911(g) of the FD&C Act is based
on the scientific information submitted
by the applicant as well as the scientific
evidence and other information that is
made available to the Agency, including
through public comments.
Section 911(g) of the FD&C Act
describes the demonstrations applicants
must make to obtain an order from FDA
under either section 911(g)(1) or (2). The
applicant, R.J. Reynolds Tobacco Co., is
seeking orders under section 911(g)(1)
for each of the 6 products that are the
subject of the submitted MRTPAs. A
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60204-60206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27275]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6535]
Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Standards Development
and the Use of Standards in Regulatory Submissions Reviewed in the
Center for Biologics Evaluation and Research; Draft Guidance for
Industry and Food and Drug Administration Staff.'' The draft guidance
document recognizes the value of standards and encourages the use of
appropriate standards to facilitate the evaluation of products
regulated by the Center for Biologics Evaluation and Research (CBER).
The guidance describes CBER's recommendations on the use of standards
in product development and the use of such standards in CBER's managed
review process. The draft guidance does not endorse the activities of
specific Standards Development Organizations or recommend specific
standards for use in regulatory submissions.
DATES: Submit either electronic or written comments on the draft
guidance by March 19, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 60205]]
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-2017-D-6535 for ``Standards Development and the Use of Standards in
Regulatory Submissions Reviewed in the Center for Biologics Evaluation
and Research; Draft Guidance for Industry and Food and Drug
Administration Staff.'' 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
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 the office in
processing your requests. The draft 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 electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Angela Moy, 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 is announcing the availability of a draft document entitled
``Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; Draft Guidance for Industry and Food and Drug Administration
Staff.'' The Federal Government's policies on the use of standards
developed by voluntary consensus standard bodies are described in the
Office of Management and Budget Circular A-119, ``Federal Participation
in the Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities.'' The policies outlined in Circular
A-119 were codified in the National Technology Transfer and Advancement
Act of 1995 (NTTAA). The NTTAA authorizes the National Institute of
Standards and Technology to coordinate standards activities for Federal
Agencies.
CBER recognizes the value of standards and encourages the use of
appropriate standards in the development of CBER-regulated medical
products. Sponsors' use of standards can facilitate product development
and a more efficient evaluation of regulatory submissions. The draft
guidance describes CBER's recommendations on the use of standards in
product development and the use of such standards in CBER's managed
review process. It describes how standards are developed, the benefits
of using standards, and CBER's policy on accepting standards used in
regulatory submissions. CBER's use of, and CBER's acceptance of
sponsors' use of, voluntary consensus standards do not constitute a
delegation of CBER's regulatory responsibilities. Whether or not
standards are used, CBER retains the ability to set, and the
responsibility for setting, appropriate regulatory criteria for CBER-
regulated products.
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 standards
development and the use of standards in regulatory submissions reviewed
in CBER. 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.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/
[[Page 60206]]
default.htm or https://www.regulations.gov.
Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27275 Filed 12-18-17; 8:45 am]
BILLING CODE 4164-01-P
