Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability, 3336-3338 [2017-00411]
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3336
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Emily Baker, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5203, Silver Spring,
MD 20993–0002, 301–796–7524,
Emily.Baker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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19:05 Jan 10, 2017
Jkt 241001
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With Cardiovascular
Related Imagery.’’ Aspirin is a common
active ingredient in many prescription
and OTC drug products. Most OTC
aspirin drug products are currently
marketed pursuant to the Tentative
Final Monograph (TFM) for Internal
Analgesic, Antipyretic, and
Antirheumatic (IAAA) Drug Products
(53 FR 46204, November 16, 1988) for
the temporary relief of minor aches and
pains associated with a cold, headache,
backache, toothache, premenstrual and
menstrual cramps; minor pain of
arthritis; and reduction in fever.
In addition to the OTC conditions of
use in the IAAA TFM, FDA regulations
at § 343.80 (21 CFR 343.80) also contain
professional labeling about
cardiovascular uses of aspirin directed
at health care practitioners (63 FR
56802, October 23, 1998). After
publication of the professional labeling
regulation for aspirin, some OTC aspirin
labels were modified to include
cardiovascular related imagery (e.g.,
heart image, electrocardiography
graphic, stethoscope around a heart
image). However, the final rule for
IAAA products at § 343.80 authorizes
labeling for cardiovascular events only
in professional labeling directed to
health care professionals.
Because of the potential side effects
associated with long-term aspirin
therapy, FDA recommends that any
cardiovascular related imagery on OTC
aspirin labels be accompanied by a
statement that reminds consumers to
talk to their health care provider before
using aspirin for the professional
indication of secondary prevention of
cardiovascular events. Therefore, this
draft guidance provides that FDA does
not intend to take action against
manufacturers of single-ingredient
aspirin, buffered aspirin, and aspirin in
combination with an antacid, marketed
pursuant to the TFM for IAAA Drug
Products because the product label
includes cardiovascular related imagery
(e.g., heart image, electrocardiography
graphic, stethoscope around a heart
image) if the label also includes
language as described in the draft
guidance recommending that patients
talk to a health care professional before
taking aspirin for cardiovascular uses
and the product is otherwise marketed
in accordance with the TFM.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. 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.
II. Paperwork Reduction Act of 1995
The recommendations in this draft
guidance are not subject to review by
the Office of Management and Budget
because they do not constitute a
‘‘collection of information’’ under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). Rather, the labeling
statements are a ‘‘public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public’’
(5 CFR 1320.3(c)(2)).
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00374 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0198]
Current Good Manufacturing Practice
Requirements for Combination
Products; 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) is announcing the
availability of a final guidance for
industry and FDA staff entitled ‘‘Current
Good Manufacturing Practice
Requirements for Combination
Products.’’ The guidance describes and
explains the document on current good
manufacturing practice (CGMP)
requirements for combination products,
which published in the Federal Register
of January 22, 2013, and includes
general considerations for CGMP
compliance as well as analysis of
hypothetical scenarios.
SUMMARY:
E:\FR\FM\11JAN1.SGM
11JAN1
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
Submit either electronic or
written comments on this guidance at
any time.
ADDRESSES: You may submit comments
as follows:
DATES:
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’’).
sradovich on DSK3GMQ082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2015–D–0198 for ‘‘Current Good
Manufacturing Practice Requirements
for Combination Products; Final
Guidance for Industry and FDA 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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
• 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance document
entitled ‘‘Current Good Manufacturing
Practice Requirements for Combination
Products’’ to the Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns or John Barlow Weiner,
Office of Combination Products, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129,
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
3337
Silver Spring, MD 20993–0002, 301–
796–8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Current Good Manufacturing
Practice Requirements for Combination
Products.’’ The guidance provides
background on combination products,
including an overview of the document
on CGMP requirements for combination
products, which published in the
Federal Register of January 22, 2013 (78
FR 4307), and the role of the lead center
and other Agency components with
respect to combination product CGMP
issues. The guidance addresses general
considerations for CGMP requirements
for combination products and the
purpose and content of specific CGMP
provisions addressed in part 4 (21 CFR
part 4). The guidance also contains
hypothetical scenarios intended to
clarify how to comply with certain
CGMP requirements addressed in part 4
by presenting compliance
considerations for specific types of
combination products.
FDA carefully considered the
comments received on the draft
guidance, and, where possible, has
incorporated into the final guidance
additional detailed discussion of how
the requirements apply and acceptable
CGMP compliance approaches. FDA
encourages combination product
manufacturers to contact the lead Center
for their combination product and/or
the Office of Combination Products if
they have questions on CGMP
compliance or approaches they are
considering for meeting CGMP
requirements.
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/downloads/
RegulatoryInformation/Guidances/
UCM429304.pdf.
III. Paperwork Reduction Act
This guidance 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). We note that the information
collected under the underlying CGMP
regulations for drugs, devices, and
biological products, including current
good tissue practices for human cells,
tissues, and cellular and tissue-based
products, found at parts 211, 820, 600
through 680, and 1271 (21 CFR parts
E:\FR\FM\11JAN1.SGM
11JAN1
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Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
211, 820, 600 through 680, and 1271),
have already been approved and are in
effect. The provisions of part 211 are
approved under OMB control number
0910–0139. The provisions of part 820
are approved under OMB control
number 0910–0073. The provisions of
parts 606 and 640 are approved under
OMB control number 0910–0116. The
provisions of part 610 are approved
under OMB control numbers 0910–0116
and 0910–0338 (also for part 680). The
provisions of part 1271, subparts C and
D, are approved under OMB control
number 0910–0543.
Dated: January 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00411 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Nurse Anesthetist
Traineeship (NAT) Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 10,
2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Nurse Anesthetist Traineeship (NAT)
Program Application
OMB No.: 0915–0374—Revision
Abstract: HRSA provides advanced
education nursing training grants to
educational institutions to increase the
numbers of Nurse Anesthetists through
the NAT Program. The NAT Program is
authorized by Section 811 of the Public
Health Service (PHS) Act (42 U.S.C.
296j). The NAT Tables request
information on program participants
from the previous year, including the
number of enrollees; number of
enrollees/trainees supported; number of
graduates; number of graduates
supported; projected data on the
number of enrollees/trainees and
graduates; the degree program (Master’s
and Doctoral) the Nurse Anesthesia
student trainees are enrolling into and/
or from which enrollees/trainees are
graduating; and the distribution of
Nurse Anesthetists who practice in
underserved, rural, and/or public health
practice settings.
Need and Proposed Use of the
Information: Funds appropriated for the
NAT Program are distributed among
eligible institutions based on a formula,
as permitted by PHS Act Section
806(e)(1). HRSA uses the data from the
NAT Tables to determine the award
amount, ensure compliance with
programmatic and grant requirements,
and provide information to the public
and Congress.
HRSA is streamlining the data
collection forms from three tables to two
tables by making the following changes:
• Table 1—NAT: Enrollment,
Traineeship Support, Graduates,
Graduates Supported, and Projected
Data will no longer capture data by
students in the first 12 months of study
and students beyond the first 12 months
of study in the program. Data will
continue to be captured by Master’s and
Doctoral students.
• Table 2A—NAT: Graduate Data—
Rural, Underserved, or Public Health is
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
now Table 2 due to the elimination of
Table 2B. There are no other changes to
this form.
• Table 2B—NAT: Graduates
Supported by Traineeship Data—Rural,
Underserved, or Public Health (7/01/15–
6/30/16) will be discontinued.
Rationale: The NAT Program Specific
Data Forms will be revised to streamline
the process and capture only essential
data for use in the formula calculation,
ensure grantee compliance, and measure
and evaluate the program.
Likely Respondents: Eligible
applicants are education programs that
provide registered nurses with full-time
nurse anesthesia education and are
accredited by the Council on
Accreditation (COA) of Nurse
Anesthesia Educational Programs. Such
programs may include schools of
nursing, nursing centers, academic
health centers, state or local
governments, and other public or
private nonprofit entities authorized by
the Secretary to confer degrees to
registered nurses for full-time nurse
anesthesia education. Faith-based and
community-based organizations, Tribes,
and tribal organizations may apply for
these funds if otherwise eligible. In
addition to the 50 states, the District of
Columbia, Guam, the Commonwealth of
Puerto Rico, the Northern Mariana
Islands, American Samoa, the U.S.
Virgin Islands, the Federated States of
Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau may apply.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
E:\FR\FM\11JAN1.SGM
11JAN1
Agencies
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3336-3338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0198]
Current Good Manufacturing Practice Requirements for Combination
Products; 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) is announcing the
availability of a final guidance for industry and FDA staff entitled
``Current Good Manufacturing Practice Requirements for Combination
Products.'' The guidance describes and explains the document on current
good manufacturing practice (CGMP) requirements for combination
products, which published in the Federal Register of January 22, 2013,
and includes general considerations for CGMP compliance as well as
analysis of hypothetical scenarios.
[[Page 3337]]
DATES: Submit either electronic or written comments on this guidance at
any time.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-D-0198 for ``Current Good Manufacturing Practice Requirements
for Combination Products; Final Guidance for Industry and FDA 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance document
entitled ``Current Good Manufacturing Practice Requirements for
Combination Products'' to the Office of Combination Products, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Melissa Burns or John Barlow Weiner,
Office of Combination Products, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-
796-8930.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Current Good Manufacturing Practice Requirements
for Combination Products.'' The guidance provides background on
combination products, including an overview of the document on CGMP
requirements for combination products, which published in the Federal
Register of January 22, 2013 (78 FR 4307), and the role of the lead
center and other Agency components with respect to combination product
CGMP issues. The guidance addresses general considerations for CGMP
requirements for combination products and the purpose and content of
specific CGMP provisions addressed in part 4 (21 CFR part 4). The
guidance also contains hypothetical scenarios intended to clarify how
to comply with certain CGMP requirements addressed in part 4 by
presenting compliance considerations for specific types of combination
products.
FDA carefully considered the comments received on the draft
guidance, and, where possible, has incorporated into the final guidance
additional detailed discussion of how the requirements apply and
acceptable CGMP compliance approaches. FDA encourages combination
product manufacturers to contact the lead Center for their combination
product and/or the Office of Combination Products if they have
questions on CGMP compliance or approaches they are considering for
meeting CGMP requirements.
II. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf.
III. Paperwork Reduction Act
This guidance 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). We
note that the information collected under the underlying CGMP
regulations for drugs, devices, and biological products, including
current good tissue practices for human cells, tissues, and cellular
and tissue-based products, found at parts 211, 820, 600 through 680,
and 1271 (21 CFR parts
[[Page 3338]]
211, 820, 600 through 680, and 1271), have already been approved and
are in effect. The provisions of part 211 are approved under OMB
control number 0910-0139. The provisions of part 820 are approved under
OMB control number 0910-0073. The provisions of parts 606 and 640 are
approved under OMB control number 0910-0116. The provisions of part 610
are approved under OMB control numbers 0910-0116 and 0910-0338 (also
for part 680). The provisions of part 1271, subparts C and D, are
approved under OMB control number 0910-0543.
Dated: January 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00411 Filed 1-10-17; 8:45 am]
BILLING CODE 4164-01-P