Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 5446-5447 [2020-01655]
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Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices
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.govinfo.gov/content/pkg/FR-201509-18/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copies of the draft guidance to the Office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 The draft guidance may also be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for electronic access to the draft
guidance document.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:
Jenifer Roe, 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:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance document entitled
‘‘Interpreting Sameness of Gene Therapy
Products Under the Orphan Drug
Regulations.’’ The draft guidance
provides FDA’s current thinking on the
criteria to determine sameness of human
gene therapy products for the purpose of
orphan drug designation and orphan
drug exclusivity. The draft guidance is
intended to assist stakeholders,
including industry and academic
sponsors who seek orphan drug
designation and orphan drug
exclusivity, in the development of gene
therapies for rare diseases. The draft
guidance focuses specifically on factors
FDA intends to consider when
determining sameness for gene therapy
products and does not address sameness
determinations for other types of
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 ‘‘Interpreting Sameness of Gene
Therapy Products Under the Orphan
Drug Regulations.’’ 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
This draft guidance refers to
previously approved FDA collections of
information. 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. 3501–3521). The
collections of information in 21 CFR
part 316 have been approved under
OMB control number 0910–0167, and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01705 Filed 1–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3442; FDA–
2013–N–0557; FDA–2013–N–0514; FDA–
2013–N–0190; FDA–2013–N–1428; FDA–
2019–N–0075; FDA–2016–N–2544; FDA–
2019–N–2778; FDA–2012–N–0977; FDA–
2013–N–0823; FDA–2009–N–0380; FDA–
2013–N–1147; FDA–2010–N–0117; FDA–
2010–D–0350; FDA–2010–D–0319; FDA–
2012–D–0530; and FDA–2016–N–2683]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St. North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States .....................................................
Postmarket Surveillance of Medical Devices ..........................................................................................................
Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization .............................
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0910–0881
0910–0449
0910–0607
Date approval
expires
1/31/2021
11/30/2022
11/30/2022
Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices
5447
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
number
Title of collection
Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by
the Family Smoking Prevention and Tobacco Control Act ..................................................................................
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act .....................................................................................................
Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful
Constituents in Tobacco Products and Tobacco Smoke ....................................................................................
Medical Devices; Current Good Manufacturing Practice Quality System Regulation ............................................
Threshold of Regulation for Substances Used in Food-Contact Articles ...............................................................
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children
and Adolescents ...................................................................................................................................................
Format and Content Requirements for Over-the-Counter Drug Product Labeling .................................................
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications ..........................
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for
Food Safety and Applied Nutrition .......................................................................................................................
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims ........................................................
Guidance for Tobacco Retailers on Tobacco Retailer Training Programs .............................................................
Dear Health Care Provider Letters: Improving Communication of Important Safety Information ..........................
Requests for Feedback on Medical Device Submissions .......................................................................................
Data to Support Social and Behavioral Research as Used by the Food and Drug Administration .......................
Dated: January 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01655 Filed 1–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Chemistry, Manufacturing, and Control
Information for Human Gene Therapy
Investigational New Drug Applications;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Electronic Submissions
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Chemistry,
Manufacturing, and Control (CMC)
Information for Human Gene Therapy
Investigational New Drug Applications
(INDs); Guidance for Industry.’’ The
guidance document provides sponsors
of human gene therapy INDs with
recommendations regarding CMC
information to be submitted in an IND.
The guidance document informs
sponsors how to provide sufficient CMC
information required to assure product
safety, identity, quality, purity, and
strength (including potency) of the
investigational product. The guidance
applies to human gene therapy products
and to combination products that
contain a human gene therapy in
combination with a drug or device.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
The announcement of the
guidance is published in the Federal
Register on January 30, 2020.
DATES:
[Docket No. FDA–2008–D–0205]
AGENCY:
The guidance announced in this
notice finalizes the draft guidance of the
same title dated July 2018 and
supersedes the document entitled
‘‘Guidance for FDA Reviewers and
Sponsors: Content and Review of
Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene
Therapy Investigational New Drug
Applications (INDs),’’ dated April 2008
(April 2008 guidance).
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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.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0671
11/30/2022
0910–0827
11/30/2022
0910–0880
0910–0073
0910–0298
11/30/2022
12/31/2022
12/31/2022
0910–0312
0910–0340
0910–0523
12/31/2022
12/31/2022
12/31/2022
0910–0541
0910–0670
0910–0745
0910–0754
0910–0756
0910–0847
12/31/2022
12/31/2022
12/31/2022
12/31/2022
12/31/2022
12/31/2022
• 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–
2008–D–0205 for ‘‘Chemistry,
Manufacturing, and Control Information
for Human Gene Therapy
Investigational New Drug Applications;
Guidance for Industry.’’ 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
E:\FR\FM\30JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5446-5447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-3442; FDA-2013-N-0557; FDA-2013-N-0514; FDA-
2013-N-0190; FDA-2013-N-1428; FDA-2019-N-0075; FDA-2016-N-2544; FDA-
2019-N-2778; FDA-2012-N-0977; FDA-2013-N-0823; FDA-2009-N-0380; FDA-
2013-N-1147; FDA-2010-N-0117; FDA-2010-D-0350; FDA-2010-D-0319; FDA-
2012-D-0530; and FDA-2016-N-2683]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection number expires
------------------------------------------------------------------------
Web-Based Pilot Survey to Assess Allergy 0910-0881 1/31/2021
to Cosmetics in the United States......
Postmarket Surveillance of Medical 0910-0449 11/30/2022
Devices................................
Administrative Procedures for Clinical 0910-0607 11/30/2022
Laboratory Improvement Amendments
Categorization.........................
[[Page 5447]]
Requirements Under the Comprehensive 0910-0671 11/30/2022
Smokeless Tobacco Health Education Act
of 1986, as Amended by the Family
Smoking Prevention and Tobacco Control
Act....................................
Electronic Drug Product Reporting for 0910-0827 11/30/2022
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act...
Experimental Study on Measuring Consumer 0910-0880 11/30/2022
Comprehension of Displays of Harmful
and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke.....
Medical Devices; Current Good 0910-0073 12/31/2022
Manufacturing Practice Quality System
Regulation.............................
Threshold of Regulation for Substances 0910-0298 12/31/2022
Used in Food-Contact Articles..........
Regulations Restricting the Sale and 0910-0312 12/31/2022
Distribution of Cigarettes and
Smokeless Tobacco to Protect Children
and Adolescents........................
Format and Content Requirements for Over- 0910-0340 12/31/2022
the-Counter Drug Product Labeling......
Product Jurisdiction: Assignment of 0910-0523 12/31/2022
Agency Component for Review of
Premarket Applications.................
Preparing a Claim of Categorical 0910-0541 12/31/2022
Exclusion or an Environmental
Assessment for Submission to the Center
for Food Safety and Applied Nutrition..
Hypertension Indication: Drug Labeling 0910-0670 12/31/2022
for Cardiovascular Outcome Claims......
Guidance for Tobacco Retailers on 0910-0745 12/31/2022
Tobacco Retailer Training Programs.....
Dear Health Care Provider Letters: 0910-0754 12/31/2022
Improving Communication of Important
Safety Information.....................
Requests for Feedback on Medical Device 0910-0756 12/31/2022
Submissions............................
Data to Support Social and Behavioral 0910-0847 12/31/2022
Research as Used by the Food and Drug
Administration.........................
------------------------------------------------------------------------
Dated: January 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01655 Filed 1-29-20; 8:45 am]
BILLING CODE 4164-01-P
