Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment; Draft Guidance for Industry; Availability, 47535-47536 [2017-22051]
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Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
Paul
Hart or Samantha Loh Collado, Center
for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Document Control Center, Bldg.
71, Rm. G335, Silver Spring, MD 20993–
0002, 877–287–1373, email:
CTPRegulations@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the prohibition of
distributing free samples of tobacco
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.
III. Electronic Access
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[Docket No. FDA–2017–D–5960]
Respiratory Syncytial Virus Infection:
Developing Antiviral Drugs for
Prophylaxis and Treatment; Draft
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Respiratory Syncytial Virus Infection:
Developing Antiviral Drugs for
Prophylaxis and Treatment.’’ The
purpose of this draft guidance is to
assist sponsors in all phases of antiviral
drug development for prophylaxis and
treatment of disease caused by
respiratory syncytial virus (RSV)
infection.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by December 11, 2017 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draft guidance before it begins work on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:
Electronic Submissions
II. Significance of Guidance
Persons with access to the internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22045 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
22:35 Oct 11, 2017
Food and Drug Administration
AGENCY:
FDA is announcing the availability of
a guidance for industry entitled ‘‘The
Prohibition of Distributing Free Samples
of Tobacco Products.’’ Title 21 of the
CFR 1140.16(d)(1) prohibits, with a
limited exception, tobacco product
manufacturers, distributors, and
retailers from distributing or causing to
be distributed any free samples of
cigarettes, smokeless tobacco, or other
tobacco products. This guidance
finalizes the draft guidance of the same
title, which was made available for
public comment as noted in the Federal
Register of January 18, 2017 (82 FR
5583), and describes, among other
things, FDA’s current thinking on how
the prohibition of distributing free
samples of tobacco products applies to
non-monetary exchanges, coupons and
discounts, membership and rewards
programs, contests and games of chance,
and the business-to-business exchange
of free samples.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 244001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
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Fmt 4703
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47535
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–5960 for ‘‘Respiratory Syncytial
Virus Infection: Developing Antiviral
Drugs for Prophylaxis and Treatment;
Draft Guidance for Industry;
Availability.’’ 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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
E:\FR\FM\12OCN1.SGM
12OCN1
47536
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
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
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 requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Murray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Respiratory Syncytial Virus Infection:
Developing Antiviral Drugs for
Prophylaxis and Treatment.’’ This draft
guidance addresses FDA’s current
thinking regarding the overall drug
development program for an indication
for treatment and prevention of disease
caused by RSV infection including
nonclinical development, early phases
of clinical development, and phase 3
trial designs. This draft guidance
focuses primarily on pediatric antiviral
drug development for RSV but also
discusses drug development for other
populations.
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 ‘‘Respiratory Syncytial Virus
Infection: Developing Antiviral Drugs
for Prophylaxis and Treatment.’’ 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
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
guidance is not subject to Executive
Order 12866.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that 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
parts 312 and 314 have been approved
under OMB control numbers 0910–0014
and 0910–0001, respectively.
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: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22051 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–new]
Agency Information Collection
Request; 60-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 December 11,
2017.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990-New-60D
and project title for reference, to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
SUMMARY:
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
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—Office of the President’s Council
on Fitness, Sports & Nutrition
(OPCFSN), Office of the Assistant
Secretary for Health.
Abstract: Initiated by the former HHS
Office on Disability, supported by the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development and the former Division of
Nutrition Research Coordination at the
National Institutes of Health, and
adopted by OPCFSN in 2011, the I Can
Do It, You Can Do It! health promotion
program is designed to provide access
and opportunities for children and
adults with a wide range of physical and
cognitive disabilities to lead healthy,
active lives. 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, stroke), many people with a
disability or caregivers who have a child
with a disability experience substantial
difficulty accessing these programs. The
program partners with K–12 schools and
school districts, colleges and
universities, and other communitybased entities that implement the
program using a mentoring approach
that has been well-documented in the
research literature as efficacious in
changing the attitudes, knowledge, and
health behaviors of individuals with
and without a disability.
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.
E:\FR\FM\12OCN1.SGM
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Agencies
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47535-47536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5960]
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs
for Prophylaxis and Treatment; 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 guidance for industry entitled
``Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for
Prophylaxis and Treatment.'' The purpose of this draft guidance is to
assist sponsors in all phases of antiviral drug development for
prophylaxis and treatment of disease caused by respiratory syncytial
virus (RSV) infection.
DATES: Submit either electronic or written comments on the draft
guidance by December 11, 2017 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 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-5960 for ``Respiratory Syncytial Virus Infection: Developing
Antiviral Drugs for Prophylaxis and Treatment; Draft Guidance for
Industry; Availability.'' 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
[[Page 47536]]
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 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
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Respiratory Syncytial Virus Infection: Developing Antiviral
Drugs for Prophylaxis and Treatment.'' This draft guidance addresses
FDA's current thinking regarding the overall drug development program
for an indication for treatment and prevention of disease caused by RSV
infection including nonclinical development, early phases of clinical
development, and phase 3 trial designs. This draft guidance focuses
primarily on pediatric antiviral drug development for RSV but also
discusses drug development for other populations.
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 ``Respiratory
Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis
and Treatment.'' 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. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22051 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P