82 FR 47535 - Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 196 (October 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47535-47536 | |
| FR Document | 2017-22051 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47535-47536] From the Federal Register Online [www.thefederalregister.org] [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No. FDA-2017-D-5960] Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of antiviral drug development for prophylaxis and treatment of disease caused by respiratory syncytial virus (RSV)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 DATES: Submit either electronic or written comments on the draft guidance by December 11, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47535
FOR FURTHER INFORMATION CONTACT: Paul DEPARTMENT OF HEALTH AND Written/Paper Submissions
Hart or Samantha Loh Collado, Center HUMAN SERVICES Submit written/paper submissions as
for Tobacco Products, Food and Drug follows:
Administration, 10903 New Hampshire Food and Drug Administration • Mail/Hand delivery/Courier (for
Ave., Document Control Center, Bldg. [Docket No. FDA–2017–D–5960] written/paper submissions): Dockets
71, Rm. G335, Silver Spring, MD 20993– Management Staff (HFA–305), Food and
0002, 877–287–1373, email: Respiratory Syncytial Virus Infection: Drug Administration, 5630 Fishers
CTPRegulations@fda.hhs.gov. Developing Antiviral Drugs for Lane, Rm. 1061, Rockville, MD 20852.
SUPPLEMENTARY INFORMATION:
Prophylaxis and Treatment; Draft • For written/paper comments
Guidance for Industry; Availability submitted to the Dockets Management
I. Background Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration,
well as any attachments, except for
FDA is announcing the availability of HHS.
information submitted, marked and
a guidance for industry entitled ‘‘The ACTION: Notice of availability. identified, as confidential, if submitted
Prohibition of Distributing Free Samples as detailed in ‘‘Instructions.’’
of Tobacco Products.’’ Title 21 of the SUMMARY: The Food and Drug
Administration (FDA or Agency) is Instructions: All submissions received
CFR 1140.16(d)(1) prohibits, with a must include the Docket No. FDA–
limited exception, tobacco product announcing the availability of a draft
guidance for industry entitled 2017–D–5960 for ‘‘Respiratory Syncytial
manufacturers, distributors, and Virus Infection: Developing Antiviral
retailers from distributing or causing to ‘‘Respiratory Syncytial Virus Infection:
Developing Antiviral Drugs for Drugs for Prophylaxis and Treatment;
be distributed any free samples of Draft Guidance for Industry;
cigarettes, smokeless tobacco, or other Prophylaxis and Treatment.’’ The
purpose of this draft guidance is to Availability.’’ Received comments will
tobacco products. This guidance be placed in the docket and, except for
assist sponsors in all phases of antiviral
finalizes the draft guidance of the same those submitted as ‘‘Confidential
drug development for prophylaxis and
title, which was made available for Submissions,’’ publicly viewable at
treatment of disease caused by
public comment as noted in the Federal https://www.regulations.gov or at the
respiratory syncytial virus (RSV)
Register of January 18, 2017 (82 FR Dockets Management Staff between 9
infection.
5583), and describes, among other a.m. and 4 p.m., Monday through
things, FDA’s current thinking on how DATES: Submit either electronic or Friday.
the prohibition of distributing free written comments on the draft guidance • Confidential Submissions—To
samples of tobacco products applies to by December 11, 2017 to ensure that the submit a comment with confidential
non-monetary exchanges, coupons and Agency considers your comment on this information that you do not wish to be
discounts, membership and rewards draft guidance before it begins work on made publicly available, submit your
programs, contests and games of chance, the final version of the guidance. comments only as a written/paper
and the business-to-business exchange ADDRESSES: You may submit comments submission. You should submit two
of free samples. on any guidance at any time as follows: copies total. One copy will include the
information you claim to be confidential
II. Significance of Guidance Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
This guidance is being issued
following way: CONFIDENTIAL INFORMATION.’’ The
consistent with FDA’s good guidance
• Federal eRulemaking Portal: Agency will review this copy, including
practices regulation (21 CFR 10.115). https://www.regulations.gov. Follow the the claimed confidential information, in
The guidance represents the current instructions for submitting comments. its consideration of comments. The
thinking of FDA on the prohibition of Comments submitted electronically, second copy, which will have the
distributing free samples of tobacco including attachments, to https:// claimed confidential information
products. It does not establish any rights www.regulations.gov will be posted to redacted/blacked out, will be available
for any person and is not binding on the docket unchanged. Because your for public viewing and posted on
FDA or the public. You can use an comment will be made public, you are https://www.regulations.gov. Submit
alternative approach if it satisfies the solely responsible for ensuring that your both copies to the Dockets Management
requirements of the applicable statutes comment does not include any Staff. If you do not wish your name and
and regulations. This guidance is not confidential information that you or a contact information to be made publicly
subject to Executive Order 12866. third party may not wish to be posted, available, you can provide this
III. Electronic Access such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
Persons with access to the internet confidential business information, such must identify this information as
may obtain an electronic version of the as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
guidance at either https:// that if you include your name, contact as ‘‘confidential’’ will not be disclosed
www.regulations.gov or https:// information, or other information that except in accordance with 21 CFR 10.20
www.fda.gov/TobaccoProducts/ identifies you in the body of your and other applicable disclosure law. For
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Labeling/RulesRegulationsGuidance/ comments, that information will be more information about FDA’s posting
default.htm. posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access
Dated: October 5, 2017.
with confidential information that you the information at: https://www.gpo.gov
Anna K. Abram, do not wish to be made available to the /fdsys/pkg/FR-2015-09-18/pdf/2015-
Deputy Commissioner for Policy, Planning, public, submit the comment as a 23389.pdf.
Legislation, and Analysis. written/paper submission and in the Docket: For access to the docket to
[FR Doc. 2017–22045 Filed 10–11–17; 8:45 am] manner detailed (see ‘‘Written/Paper read background documents or the
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
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![47536 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
received, go to https:// guidance is not subject to Executive regarding this burden estimate or any
www.regulations.gov and insert the Order 12866. other aspect of this collection of
docket number, found in brackets in the information, including any of the
II. The Paperwork Reduction Act of
heading of this document, into the following subjects: (1) The necessity and
1995
‘‘Search’’ box and follow the prompts utility of the proposed information
and/or go to the Dockets Management This draft guidance refers to collection for the proper performance of
Staff, 5630 Fishers Lane, Rm. 1061, previously approved collections of the agency’s functions; (2) the accuracy
Rockville, MD 20852. information that are subject to review by of the estimated burden; (3) ways to
You may submit comments on any the Office of Management and Budget enhance the quality, utility, and clarity
guidance at any time (see 21 CFR (OMB) under the Paperwork Reduction of the information to be collected; and
10.115(g)(5)). Act of 1995 (44 U.S.C. 3501–3520). The (4) the use of automated collection
Submit written requests for single collections of information in 21 CFR techniques or other forms of information
parts 312 and 314 have been approved technology to minimize the information
copies of the draft guidance to the
under OMB control numbers 0910–0014 collection burden.
Division of Drug Information, Center for
and 0910–0001, respectively.
Drug Evaluation and Research, Food Title of the Collection: I Can Do It,
and Drug Administration, 10001 New III. Electronic Access You Can Do It! Program Evaluation.
Hampshire Ave., Hillandale Building, Persons with access to the internet Type of Collection: New.
4th Floor, Silver Spring, MD 20993– may obtain the draft guidance at either OMB No. 0990–NEW–Office within
0002. Send one self-addressed adhesive https://www.fda.gov/Drugs/Guidance OS—Office of the President’s Council
label to assist that office in processing ComplianceRegulatoryInformation/ on Fitness, Sports & Nutrition
your requests. See the SUPPLEMENTARY Guidances/default.htm or https:// (OPCFSN), Office of the Assistant
INFORMATION section for electronic www.regulations.gov. Secretary for Health.
access to the draft guidance document. Abstract: Initiated by the former HHS
Dated: October 5, 2017.
FOR FURTHER INFORMATION CONTACT: Anna K. Abram, Office on Disability, supported by the
Jeffrey Murray, Center for Drug Deputy Commissioner for Policy, Planning, Eunice Kennedy Shriver National
Evaluation and Research, Food and Legislation, and Analysis. Institute of Child Health and Human
Drug Administration, 10903 New [FR Doc. 2017–22051 Filed 10–11–17; 8:45 am] Development and the former Division of
Hampshire Ave., Bldg. 22, Rm. 6360, Nutrition Research Coordination at the
BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301– National Institutes of Health, and
796–1500. adopted by OPCFSN in 2011, the I Can
SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Do It, You Can Do It! health promotion
HUMAN SERVICES program is designed to provide access
I. Background and opportunities for children and
[Document Identifier OS–0990–new]
FDA is announcing the availability of adults with a wide range of physical and
a draft guidance for industry entitled Agency Information Collection cognitive disabilities to lead healthy,
‘‘Respiratory Syncytial Virus Infection: Request; 60-Day Public Comment active lives. Approximately 56 million
Developing Antiviral Drugs for Request children and adults living in the United
Prophylaxis and Treatment.’’ This draft States have some level of disability.
guidance addresses FDA’s current AGENCY: Office of the Secretary, HHS Despite physical activity and good
thinking regarding the overall drug ACTION: Notice. nutrition being the cornerstones of
development program for an indication evidence-based health promotion
SUMMARY: In compliance with the interventions for reducing the risk of
for treatment and prevention of disease
requirement of the Paperwork comorbidities (e.g., diabetes, heart
caused by RSV infection including
Reduction Act of 1995, the Office of the disease, stroke), many people with a
nonclinical development, early phases
Secretary (OS), Department of Health disability or caregivers who have a child
of clinical development, and phase 3
and Human Services, is publishing the with a disability experience substantial
trial designs. This draft guidance
following summary of a proposed difficulty accessing these programs. The
focuses primarily on pediatric antiviral
collection for public comment. program partners with K–12 schools and
drug development for RSV but also
DATES: Comments on the ICR must be school districts, colleges and
discusses drug development for other
populations. received on or before December 11, universities, and other community-
2017. based entities that implement the
This draft guidance is being issued
consistent with FDA’s good guidance ADDRESSES: Submit your comments to program using a mentoring approach
practices regulation (21 CFR 10.115). Sherrette.Funn@hhs.gov or by calling that has been well-documented in the
The draft guidance, when finalized, will (202) 795–7714. research literature as efficacious in
represent the current thinking of FDA FOR FURTHER INFORMATION CONTACT: changing the attitudes, knowledge, and
on ‘‘Respiratory Syncytial Virus When submitting comments or health behaviors of individuals with
Infection: Developing Antiviral Drugs requesting information, please include and without a disability.
for Prophylaxis and Treatment.’’ It does the document identifier 0990-New-60D The information collected for the I
not establish any rights for any person and project title for reference, to Can Do It, You Can Do It! Program
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and is not binding on FDA or the public. Sherrette.funn@hhs.gov, or call the Evaluation will allow the OPCFSN and
You can use an alternative approach if Reports Clearance Officer. partners to assess the impact of the
it satisfies the requirements of the SUPPLEMENTARY INFORMATION: Interested program and gather critical information
applicable statutes and regulations. This persons are invited to send comments for improvement.
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Document Created: 2018-10-25 10:03:49
Document Modified: 2018-10-25 10:03:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 47535 |
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