Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop, 26691-26692 [2017-11862]

Download as PDF 26691 Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No.: 0970–0030] Proposed Information Collection Activity; Comment Request; Refugee Assistance Program Estimates: CMA— ORR–1 Description: The ORR–1, Cash and Medical Assistance (CMA) Program Estimates, is the application for grants under the CMA program. The application is required by the Office of Refugee Resettlement (ORR) program regulations at 45 CFR 400.11(b). The regulation specifies that States must submit, as their application for this program, estimates of the projected costs they anticipate incurring in providing cash and medical assistance for eligible recipients and the costs of administering the program. Under the CMA program, States are reimbursed for the costs of providing these services and benefits for eight months after an eligible recipient arrives in this country. The eligible recipients for these services and benefits are refugees, Amerasians, Cuban and Haitian Entrants, asylees, Afghans and Iraqi with Special Immigrant Visas, and victims of a severe form of trafficking. States that provide services for unaccompanied refugee minors also provide an estimate for the cost of these services for the year for which they are applying for grants. ORR proposes streamlining language to make the instructions easier to read. ORR proposes adding language for clarification and consistency across programs. Additionally, ORR proposes to require states to submit copies of their contracts with URM providers with the submission. Respondents: State Agencies, Replacement Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State 2 Agencies) administering or supervising the administration of programs under Title IV of the Act. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ORR–1, Cash and Medical Assistance Program Estimates ........................... asabaliauskas on DSKBBXCHB2PROD with NOTICES Instrument 55 1 0.60 27.60 Estimated Total Annual Burden Hours: 27.60. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Ch. 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to VerDate Sep<11>2014 17:24 Jun 07, 2017 Jkt 241001 comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–11874 Filed 6–7–17; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious Diseases are announcing a public workshop entitled ‘‘Bacteriophage Therapy: Scientific and Regulatory Issues.’’ The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy. DATES: The public workshop will be held on July 10, 2017, from 8:30 a.m. to 5 p.m. and July 11, 2017, from 8:30 a.m. to 3 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 The public workshop will be held at 5601 Fishers Lane, Rm. 1D– 13, Rockville, MD 20852. Entrance for public workshop participants is through the lobby where routine security check procedures will be performed. For parking and security information, please refer to the registration Web site provided in section III of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: James Ginther or Cynthia Whitmarsh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122, Silver Spring, MD 20993, Ph. 240–402–8010, email: CBERPublicEvents@fda.hhs.gov (subject line: Bacteriophage Public Workshop). SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background Since their discovery approximately one hundred years ago, bacteriophages have been investigated as a way to treat bacterial infections. In much of the world, the discovery, development, and implementation of antibiotic therapies led to a loss of interest in bacteriophages as a means to fight infections. However, in recent years, interest in this form of treatment has resurged, fueled by the increasing prevalence of antibioticresistant bacteria. II. Topics for Discussion at the Public Workshop The public workshop will bring together government agencies, academia, industry, and other stakeholders involved in research, E:\FR\FM\08JNN1.SGM 08JNN1 26692 Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Notices development, and regulation of bacteriophages intended for therapeutic use in humans. The aims of the workshop are to discuss the scientific and regulatory considerations for bacteriophage therapies and to provide a forum for the exchange of information and perspectives, with the ultimate goal of facilitating development and rigorous clinical assessment of bacteriophage therapy products. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following Web site: https://www.eventbrite.com/e/ bacteriophage-therapy-publicworkshop-tickets-32333252629. Persons interested in attending this public workshop must register online by June 29, 2017. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. There will be no onsite registration. If you need special accommodations due to disability, please contact James Ginther or Cynthia Whitmarsh no later than 7 days in advance of the workshop (see FOR FURTHER INFORMATION CONTACT). Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the Internet at: https://www.fda.gov/BiologicsBlood Vaccines/NewsEvents/Workshops MeetingsConferences/ucm544294.htm. Dated: June 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–11862 Filed 6–7–17; 8:45 am] asabaliauskas on DSKBBXCHB2PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the 2018 Physical Activity Guidelines Advisory Committee Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: VerDate Sep<11>2014 17:24 Jun 07, 2017 Jkt 241001 ACTION: Notice. As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the fourth meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public via video cast. DATES: The meeting will be held on July 19, 2017, from 1:00 p.m. E.D.T. to 5:00 p.m. E.D.T., on July 20, 2017, from 8:00 a.m. to 5:00 p.m. E.D.T., and on July 21, 2017, from 8:00 a.m. E.D.T. to 11:00 a.m. E.D.T. ADDRESSES: The meeting will be accessible by video cast on the Internet. FOR FURTHER INFORMATION CONTACT: Designated Federal Officer, 2018 Physical Activity Guidelines Advisory Committee, Richard D. Olson, M.D., M.P.H. and/or Alternate Designated Federal Officer, Katrina L. Piercy, Ph.D., R.D., Office of Disease Prevention and Health Promotion (ODPHP), Office of the Assistant Secretary for Health (OASH), HHS; 1101 Wootton Parkway, Suite LL–100; Rockville, MD 20852; Telephone: (240) 453–8280. Additional information is available at www.health.gov/paguidelines. SUPPLEMENTARY INFORMATION: The inaugural Physical Activity Guidelines for Americans (PAG), issued in 2008, represents the first comprehensive guidelines on physical activity issued by the federal government. The PAG serves as the benchmark and primary, authoritative voice of the federal government for providing science-based guidance on physical activity, fitness, and health for Americans. The second edition of the PAG will build upon the first edition and provide a foundation for federal recommendations and education for physical activity programs for Americans, including those at risk for chronic disease. Description of the Committee’s Mission and Composition: The 2018 PAGAC was established to perform a single, time-limited task. The work of the Committee is solely advisory in nature. The Committee is charged to examine the current PAG, take into consideration new scientific evidence and current resource documents, and develop a scientific report to the Secretary of HHS that outlines its science-based advice and recommendations for development of the second edition of the PAG. The Committee consists of 17 members, who were appointed by the Secretary in June 2016. Information on the Committee membership is available at SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 www.health.gov/paguidelines/secondedition/committee/. It is planned for the Committee to hold five meetings to accomplish its mission. The first meeting was held in July 2016, the second meeting was held in October 2016, and the third meeting was held in March 2017. It is planned for the fifth meeting of the Committee to be held during the third week in October 2017. It is stipulated in the charter that the Committee will be terminated after delivery of its report to the Secretary of HHS or two years from the date the charter was filed, whichever comes first. Purpose of the Meeting: In accordance with FACA and to promote transparency of the process, deliberations of the Committee will occur in a public forum. At this meeting, the Committee will continue its deliberations from the last public meeting. Meeting Agenda: The meeting will include review of subcommittee work since the last public meeting and deliberation by the full Committee, discussion of overarching issues, and plans for future Committee work. Meeting Registration: The meeting is open to the public via video cast; preregistration is required. To register, please visit www.health.gov/ paguidelines. After registration, individuals will receive video cast access information via email. To request a special accommodation, please email jennifer.gillissen@kauffmaninc.com. Public Comments and Meeting Documents: Written comments from the public are being accepted throughout the Committee’s deliberative process and can be submitted and/or viewed at www.health.gov/paguidelines/pcd/. Documents pertaining to Committee deliberations, including meeting agendas and summaries are available on www.health.gov/paguidelines. Meeting information will continue to be accessible online and upon request at the Office of Disease Prevention and Health Promotion, OASH/HHS; 1101 Wootton Parkway, Suite LL100 Tower Building; Rockville, MD 20852; Telephone: (240) 453–8280; Fax: (240) 453–8281. Dated: May 17, 2017. Don Wright, Deputy Assistant Secretary for Health, (Disease Prevention and Health Promotion). [FR Doc. 2017–11898 Filed 6–7–17; 8:45 am] BILLING CODE 4150–32–P E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Notices]
[Pages 26691-26692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11862]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Bacteriophage Therapy: Scientific and Regulatory Issues; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research, and the National Institutes of Health, 
National Institute of Allergy and Infectious Diseases are announcing a 
public workshop entitled ``Bacteriophage Therapy: Scientific and 
Regulatory Issues.'' The purpose of the public workshop is to exchange 
information with the medical and scientific community about the 
regulatory and scientific issues associated with bacteriophage therapy.

DATES: The public workshop will be held on July 10, 2017, from 8:30 
a.m. to 5 p.m. and July 11, 2017, from 8:30 a.m. to 3 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at 5601 Fishers Lane, Rm. 
1D-13, Rockville, MD 20852. Entrance for public workshop participants 
is through the lobby where routine security check procedures will be 
performed. For parking and security information, please refer to the 
registration Web site provided in section III of the SUPPLEMENTARY 
INFORMATION section.

FOR FURTHER INFORMATION CONTACT: James Ginther or Cynthia Whitmarsh, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122, Silver 
Spring, MD 20993, Ph. 240-402-8010, email: CBERPublicEvents@fda.hhs.gov 
(subject line: Bacteriophage Public Workshop).

SUPPLEMENTARY INFORMATION:

I. Background

    Since their discovery approximately one hundred years ago, 
bacteriophages have been investigated as a way to treat bacterial 
infections. In much of the world, the discovery, development, and 
implementation of antibiotic therapies led to a loss of interest in 
bacteriophages as a means to fight infections. However, in recent 
years, interest in this form of treatment has resurged, fueled by the 
increasing prevalence of antibiotic-resistant bacteria.

II. Topics for Discussion at the Public Workshop

    The public workshop will bring together government agencies, 
academia, industry, and other stakeholders involved in research,

[[Page 26692]]

development, and regulation of bacteriophages intended for therapeutic 
use in humans. The aims of the workshop are to discuss the scientific 
and regulatory considerations for bacteriophage therapies and to 
provide a forum for the exchange of information and perspectives, with 
the ultimate goal of facilitating development and rigorous clinical 
assessment of bacteriophage therapy products.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site: https://www.eventbrite.com/e/bacteriophage-therapy-public-workshop-tickets-32333252629. Persons interested in attending 
this public workshop must register online by June 29, 2017. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. There will be no onsite registration.
    If you need special accommodations due to disability, please 
contact James Ginther or Cynthia Whitmarsh no later than 7 days in 
advance of the workshop (see FOR FURTHER INFORMATION CONTACT).
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to 
the transcript will also be available on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm544294.htm.

    Dated: June 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11862 Filed 6-7-17; 8:45 am]
BILLING CODE 4164-01-P

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