Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry; Availability, 60750-60752 [2017-27589]
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60750
Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
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organizations, disease advocacy
organizations, voluntary health
agencies, nonprofit research
foundations, and public health
organizations. The ultimate goal of the
nomination and selection process is to
identify individuals who can represent
a collective patient voice for their
patient community.
Selection criteria include the
nominee’s potential to meaningfully
contribute to the activities of the PEC,
ability to represent and express the
patient voice for his or her constituency,
ability to work in a constructive manner
with involved stakeholders, and
understanding of the clinical research
enterprise. Consideration will also be
given to ensuring the PEC includes
diverse perspectives and experiences,
including but not limited to,
sociodemographic and disease
experience diversity. It is anticipated
that approximately half of the PEC
membership will be selected from
eligible CTTI member organizations and
individuals, and half will be selected
from other nominees. Members are
required to be citizens and residents of
the United States.
Financial and other conflicts of
interest will not necessarily make
nominees ineligible for membership in
the PEC. However, nominees cannot be
direct employees of the medical product
development industry.
III. Responsibilities and Expectations
Meetings of the PEC will typically be
held four times per year, either inperson (in the Washington, DC area) or
by webinar, and additional meetings
may be organized as needed.
Accommodations will be made for
members with special needs for travel or
for participation in a meeting (e.g.,
accommodations for physical mobility
impairments, dietary restrictions, etc.).
Nominations for PEC membership are
encouraged for individuals of all racial,
ethnic, sexual orientation, and cultural
groups with and without disabilities.
Travel support will be provided.
To help ensure continuity in its
activities and organizational knowledge,
the PEC will maintain staggered
membership terms for patient
community representatives.
Membership terms are anticipated as 1to 2-year appointments, and will be
determined during the process of
selecting members. Members may serve
up to two terms, with the possibility of
extensions.
Additional responsibilities and
expectations are set forth in the Patient
Engagement Collaborative Framework,
which should be reviewed prior to
submitting a nomination. The full text
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of the Patient Engagement Collaborative
Framework is available at https://
www.ctti-clinicaltrials.org/frameworkcttifda-patient-engagementcollaborative.
IV. Nomination Process
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1995–D–0288 (Formerly
Docket No. 95D–0052)]
Any interested person may nominate
one or more qualified individuals for
membership on the PEC. Selfnominations are also accepted.
Nominations should include the
following: (1) A personal statement
(maximum 800 words) from the
nominee explaining his or her interest
in becoming a member of the PEC; (2)
a current, complete curriculum vitae or
resume that shows relevant activities
and experience; and (3) an optional
letter of endorsement (maximum 800
words) from a patient group with which
the nominee has worked closely on
activities relevant to the PEC.
The personal statement and optional
letter of endorsement (if provided)
should emphasize information relevant
to the criteria for membership described
above. The letter may address topics
such as the nominee’s involvement in
patient advocacy activities, experiences
that stimulated an interest in
participating in discussions about
patient engagement in medical product
development and regulatory decisionmaking, and other information that may
be helpful in evaluating the nominee’s
qualifications as a potential member of
the PEC.
Nominations must provide the
nominee’s contact information (phone
and email preferred), as well as state
that the nominee is aware of the
nomination (unless self-nominated) and
is willing to serve as a member of the
PEC.
Additional information may be
needed from nominees, including
information relevant to understanding
potential sources of conflict of interest,
in which case nominees will be
contacted directly.
Chemistry, Manufacturing, and
Controls Changes to an Approved
Application: Certain Biological
Products; Draft Guidance for Industry;
Availability
Dated: December 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2017–27538 Filed 12–20–17; 8:45 am]
BILLING CODE 4164–01–P
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AGENCY:
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 ‘‘Chemistry,
Manufacturing, and Controls Changes to
an Approved Application: Certain
Biological Products; Draft Guidance for
Industry.’’ The draft guidance is
intended to assist applicants and
manufacturers of certain licensed
biological products in determining
which reporting category is appropriate
for a change in chemistry,
manufacturing, and controls (CMC)
information to an approved biologics
license application (BLA). The draft
guidance provides applicants and
manufacturers general and
administrative information on reporting
and evaluating changes and
recommendations for reporting
categories based on a tiered-reporting
system for specific changes. The draft
guidance, when finalized, is intended to
supersede the document entitled
‘‘Guidance for Industry: Changes to an
Approved Application: Biological
Products’’ dated July 1997 (July 1997
guidance).
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by March 22, 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:
DATES:
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
E:\FR\FM\22DEN1.SGM
22DEN1
Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–
1995–D–0288 (formerly Docket No.
95D–0052) for ‘‘Chemistry,
Manufacturing, and Controls Changes to
an Approved Application: Biological
Products.’’ 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
VerDate Sep<11>2014
16:59 Dec 21, 2017
Jkt 244001
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 (CBER), 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:
Jessica T. Walker, 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 ‘‘Chemistry,
Manufacturing, and Controls Changes to
an Approved Application: Certain
Biological Products; Draft Guidance for
Industry.’’ The draft guidance, when
finalized, is intended to assist
applicants and manufacturers of
licensed biological products in
determining which reporting category is
appropriate for a change in CMC to an
approved BLA as specified in 21 CFR
601.12. The draft guidance provides
PO 00000
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Sfmt 4703
60751
applicants and manufacturers general
and administrative information on
reporting and evaluating changes and
recommendations for reporting
categories based on a tiered-reporting
system for specific changes under
§ 601.12.
FDA issued the July 1997 guidance
(62 FR 39904; July 24, 1997) to assist
applicants in determining which
reporting mechanism is appropriate for
reporting a change to an approved
application to reduce the burden on
manufacturers when reporting changes
and to facilitate the approval process of
the change being made. We are updating
the July 1997 guidance to accommodate
advances in manufacturing and testing
technology and to clarify the FDA’s
current thinking on assessing reportable
changes. The updated guidance applies
to certain biological products licensed
under the Public Health Service Act
(PHS Act), including in vitro diagnostics
licensed under BLAs. This draft
guidance applies to all manufacturing
locations, including contract locations.
The following biological products are
not within the scope of this guidance:
Whole blood, blood components, source
plasma, and source leukocytes. This
draft guidance also does not apply to
human cells, tissues, and cellular and
tissue-based products regulated solely
under section 361 of the PHS Act (42
U.S.C. 264), as described in 21 CFR part
1271; specified biotechnology and
specified synthetic biological products;
and biosimilar biological products
subject to licensure under section 351(k)
of the PHS Act. The draft guidance,
when finalized, is intended to supersede
the July 1997 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 ‘‘Chemistry, Manufacturing, and
Controls Changes to an Approved
Application: Certain Biological
Products.’’ 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. Paperwork Reduction Act of 1995
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 210 and
E:\FR\FM\22DEN1.SGM
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60752
Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
21 CFR part 211 have been approved
under OMB control number 0910–0139;
the collections of information in 21 CFR
601.12 have been approved under OMB
control numbers 0910–0338, and the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27589 Filed 12–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 22, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
SUMMARY:
show that one-on-one mentoring
through healthy eating, physical
activity, and sport participation can
support the development of social skills,
improve positive self-esteem, and
increase self-confidence among children
and adults with a disability. I Can Do It,
You Can Do It! partners with K–12
schools and school districts, colleges
and universities, and other communitybased entities to provide access and
opportunities for children and adults
with a wide range of physical and
cognitive disabilities to lead healthy,
active lives. PCFSN plans to conduct a
rigorous evaluation of I Can Do It, You
Can Do It! The evaluation will assess the
impact of the program on mentee level
outcomes (impact evaluation) as well as
barriers and facilitators to program
implementation (process evaluation).
Evaluation activities will take place in
10 sites between summer 2018 and fall
2019. The I Can Do It, You Can Do It!
sites recruited to participate in the
evaluation will be identified from a list
of schools and community organizations
that have signed up to be program sites.
The aims of the process evaluation are
to determine what parts of the program
were successful, the usefulness of
program materials, and what changes
are necessary to improve the
administration of the program. The aims
of the impact evaluation are to examine
how ICDI impacts Mentee physical
activity and healthy eating behaviors.
The information collected for the I Can
Do It, You Can Do It! Program
Evaluation will allow the OPCFSN and
partners to assess the impact of the
program and gather critical information
for improvement. OMB approval is
requested for three years. Participation
in I Can Do It, You Can Do It! is
voluntary and there are no costs to
respondents other than their time.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: I Can Do It,
You Can Do It! Program Evaluation.
Type of Collection: New.
OMB No. 0990—NEW—Office within
OS—President’s Council on Fitness,
Sports & Nutrition (PCFSN), Office of
the Assistant Secretary for Health.
Abstract: Approximately 56 million
children and adults living in the United
States have some level of disability.
Despite physical activity and good
nutrition being the cornerstones of
evidence-based health promotion
interventions for reducing the risk of
comorbidities (e.g., diabetes, heart
disease, and stroke), many people with
a disability or caregivers who have a
child with a disability experience
substantial difficulty accessing these
programs. Benefits of physical activity
and good nutrition have been well
documented for individuals with and
without a disability, including: reducing
the risk of developing chronic diseases
and medical conditions. Studies also
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
sradovich on DSK3GMQ082PROD with NOTICES
Forms
Respondents
Site Application .................................
Partner Application ............................
Site Annual Follow-Up Survey ..........
End of Wave 1 Interview ..................
End of Wave 1 Feedback Survey .....
End of Wave 2 Interview ..................
End of Wave 2 Feedback Survey .....
Technical Assistance Assessment ...
Mentee Pre-Assessment ...................
Mentee Post-Assessment .................
Mentor Feedback Survey ..................
Weekly Goal-Setting Guide ..............
Site Coordinator ...............................
National Partner Organizations ........
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Site Coordinator ...............................
Mentee/Program Participant ............
Mentee/Program Participant ............
Mentor ..............................................
Mentor ..............................................
10
50
10
10
10
10
10
10
700
700
700
700
1
1
1
1
1
1
1
1
1
1
1
8
7/60
15/60
5/60
30/60
11/60
30/60
6/60
10/60
20/60
25/60
8/60
10/60
1
12
1
5
2
5
1
2
233
292
94
936
Total ...........................................
...........................................................
........................
19
........................
1,584
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22DEN1
Agencies
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60750-60752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1995-D-0288 (Formerly Docket No. 95D-0052)]
Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Draft Guidance for Industry;
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 ``Chemistry,
Manufacturing, and Controls Changes to an Approved Application: Certain
Biological Products; Draft Guidance for Industry.'' The draft guidance
is intended to assist applicants and manufacturers of certain licensed
biological products in determining which reporting category is
appropriate for a change in chemistry, manufacturing, and controls
(CMC) information to an approved biologics license application (BLA).
The draft guidance provides applicants and manufacturers general and
administrative information on reporting and evaluating changes and
recommendations for reporting categories based on a tiered-reporting
system for specific changes. The draft guidance, when finalized, is
intended to supersede the document entitled ``Guidance for Industry:
Changes to an Approved Application: Biological Products'' dated July
1997 (July 1997 guidance).
DATES: Submit either electronic or written comments on the draft
guidance by March 22, 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:
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
[[Page 60751]]
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-1995-D-0288 (formerly Docket No. 95D-0052) for ``Chemistry,
Manufacturing, and Controls Changes to an Approved Application:
Biological Products.'' 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 (CBER), 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: Jessica T. Walker, 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
``Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Draft Guidance for
Industry.'' The draft guidance, when finalized, is intended to assist
applicants and manufacturers of licensed biological products in
determining which reporting category is appropriate for a change in CMC
to an approved BLA as specified in 21 CFR 601.12. The draft guidance
provides applicants and manufacturers general and administrative
information on reporting and evaluating changes and recommendations for
reporting categories based on a tiered-reporting system for specific
changes under Sec. 601.12.
FDA issued the July 1997 guidance (62 FR 39904; July 24, 1997) to
assist applicants in determining which reporting mechanism is
appropriate for reporting a change to an approved application to reduce
the burden on manufacturers when reporting changes and to facilitate
the approval process of the change being made. We are updating the July
1997 guidance to accommodate advances in manufacturing and testing
technology and to clarify the FDA's current thinking on assessing
reportable changes. The updated guidance applies to certain biological
products licensed under the Public Health Service Act (PHS Act),
including in vitro diagnostics licensed under BLAs. This draft guidance
applies to all manufacturing locations, including contract locations.
The following biological products are not within the scope of this
guidance: Whole blood, blood components, source plasma, and source
leukocytes. This draft guidance also does not apply to human cells,
tissues, and cellular and tissue-based products regulated solely under
section 361 of the PHS Act (42 U.S.C. 264), as described in 21 CFR part
1271; specified biotechnology and specified synthetic biological
products; and biosimilar biological products subject to licensure under
section 351(k) of the PHS Act. The draft guidance, when finalized, is
intended to supersede the July 1997 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 ``Chemistry,
Manufacturing, and Controls Changes to an Approved Application: Certain
Biological Products.'' 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. Paperwork Reduction Act of 1995
This draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 210 and
[[Page 60752]]
21 CFR part 211 have been approved under OMB control number 0910-0139;
the collections of information in 21 CFR 601.12 have been approved
under OMB control numbers 0910-0338, and the collections of information
in 21 CFR part 820 have been approved under OMB control number 0910-
0073.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27589 Filed 12-21-17; 8:45 am]
BILLING CODE 4164-01-P