Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 15617-15618 [2015-06651]
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Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
Dated: March 18, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06601 Filed 3–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0663]
Determining the Need for and Content
of Environmental Assessments for
Gene Therapies, Vectored Vaccines,
and Related Recombinant Viral or
Microbial Products; Guidance for
Industry: Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Determining the Need for and Content
of Environmental Assessments for Gene
Therapies, Vectored Vaccines, and
Related Recombinant Viral or Microbial
Products; Guidance for Industry’’ dated
March 2015. The guidance document
provides investigational new drug
application (IND) sponsors and
applicants for a biologics license
application (BLA) or a supplement to a
BLA (BLA supplement), with
recommendations on considerations
when assessing whether to submit an
Environmental Assessment (EA) for
gene therapies, vectored vaccines, and
related recombinant viral or microbial
products (GTVVs). The guidance also
contains recommendations as to what
information should be included in an
EA and what you can expect once an EA
is filed. The guidance announced in this
notice finalizes the draft guidance of the
same title dated June 2014.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the 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 guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
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SUMMARY:
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for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, 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:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Determining the
Need for and Content of Environmental
Assessments for Gene Therapies,
Vectored Vaccines, and Related
Recombinant Viral or Microbial
Products; Guidance for Industry’’ dated
March 2015. The guidance document
provides IND sponsors and applicants
for a BLA or a BLA supplement, with
recommendations on considerations
when assessing whether to submit an
EA for GTVVs. The guidance also
contains recommendations as to what
information should be included in an
EA and what you can expect once an EA
is filed. The guidance supplements the
guidance entitled ‘‘Guidance for
Industry: Environmental Assessment of
Human Drug and Biologics
Applications’’ dated July 1998 (July 27,
1998, 63 FR 40127) (1998 Guidance) and
supersedes the recommendations for
GTVVs in section IV.B.1 ‘‘Assessing
Toxicity to Environmental Organisms’’
in the 1998 Guidance. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
June 2014.
In the Federal Register of June 20,
2014 (79 FR 35361), FDA announced the
availability of the draft guidance of the
same title dated June 2014. FDA
received a few comments on the draft
guidance and those comments were
considered as the guidance was
finalized. There were no changes to the
guidance except for one correction to a
technical error regarding influenza
taxonomy. The guidance announced in
this notice finalizes the draft guidance
dated June 2014.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
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15617
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
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). The collections of information in
21 CFR part 25 have been approved
under OMB control number 0910–0322;
the collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; and
the collections of information for 21
CFR part 601 have been approved under
OMB control number 0910–0338.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: March 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06686 Filed 3–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Economic Studies of
Immunization Policies and Practices,
Funding Opportunity Announcement
(FOA) IP15–001 and US Platform to
Measure Influenza Vaccine
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Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
Effectiveness against LaboratoryConfirmed Influenza-Associated
Hospitalizations, FOA IP15–002, initial
review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time And Date: 10:00 a.m.–4:00 p.m.,
April 15, 2015 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters For Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Economic Studies of Immunization
Policies and Practices’’, FOA IP15–001
and ‘‘US Platform to Measure Influenza
Vaccine Effectiveness against
Laboratory-confirmed Influenzaassociated Hospitalizations’’, FOA IP15–
002.
Contact Person For More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE., Mailstop E60, Atlanta,
Georgia 30333, Telephone: (404) 718–
8833.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–06651 Filed 3–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Detection and Characterization
of Emerging Vector-Borne Zoonotic
Pathogens in Indonesia, CK15–001;
Sentinel Enhanced Dengue Surveillance
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System (SEDSS) Sites to Evaluate the
Epidemiology and Prevention of Dengue
and other Acute Febrile Illnesses in
Puerto Rico, CK15–002, and Capacity
Building to Prevent, Detect, and
Respond to Emerging Infectious Disease
Threats and Strengthen Global Health
Security in Uganda, CK15–003, Funding
Opportunity Announcement (FOA),
initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time And Date: 11:00 a.m.–3:00 p.m.,
April 21, 2015 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters For Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Detection and Characterization of
Emerging Vector-Borne Zoonotic
Pathogens in Indonesia’’, FOA CK15–
001 and ‘‘Sentinel Enhanced Dengue
Surveillance System (SEDSS) Sites to
Evaluate the Epidemiology and
Prevention of Dengue and other Acute
Febrile Illnesses in Puerto Rico’’, FOA
CK15–002, and ‘‘Capacity Building to
Prevent, Detect, and Respond to
Emerging Infectious Disease Threats and
Strengthen Global Health Security in
Uganda’’, FOA CK15–003.
Contact Person For More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE., Mailstop E60, Atlanta,
Georgia 30333, Telephone: (404) 718–
8833
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
[FR Doc. 2015–06652 Filed 3–23–15; 8:45 am]
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Centers for Disease Control and
Prevention
[30Day–15–15GD]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Emergency Self Escape for Coal
Miners—New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
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[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15617-15618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below concerns Economic Studies of
Immunization Policies and Practices, Funding Opportunity Announcement
(FOA) IP15-001 and US Platform to Measure Influenza Vaccine
[[Page 15618]]
Effectiveness against Laboratory-Confirmed Influenza-Associated
Hospitalizations, FOA IP15-002, initial review.
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the aforementioned meeting:
Time And Date: 10:00 a.m.-4:00 p.m., April 15, 2015 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Matters For Discussion: The meeting will include the initial
review, discussion, and evaluation of applications received in response
to ``Economic Studies of Immunization Policies and Practices'', FOA
IP15-001 and ``US Platform to Measure Influenza Vaccine Effectiveness
against Laboratory-confirmed Influenza-associated Hospitalizations'',
FOA IP15-002.
Contact Person For More Information: Gregory Anderson, M.S.,
M.P.H., Scientific Review Officer, CDC, 1600 Clifton Road NE., Mailstop
E60, Atlanta, Georgia 30333, Telephone: (404) 718-8833.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2015-06651 Filed 3-23-15; 8:45 am]
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