Agency Forms Undergoing Paperwork Reduction Act Review, 18238-18239 [2015-07670]
Download as PDF
<![CDATA[
18238
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
of marketed and investigational human
drug products for use in the treatment
of cancer.
G. Science Advisory Board to the
National Center for Toxicological
Research: Reviews and advises the
Agency on the establishment,
implementation and evaluation of the
research programs and regulatory
responsibilities as it relates to NCTR.
The Board will also provide an extraAgency review in ensuring that the
research programs at NCTR are
scientifically sound and pertinent.
H. Vaccines and Related Biological
Products Advisory Committee: Reviews
and evaluates data concerning the
safety, effectiveness, and appropriate
use of vaccines and related biological
products which are intended for use in
the prevention, treatment, or diagnosis
of human diseases, as well as considers
the quality and relevance of FDA’s
research program which provides
scientific support for the regulation of
these products.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate ties
to consumer and community-based
organizations, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
of products under review. The
consumer representative should be able
to represent the consumer perspective
on issues and actions before the
advisory committee; serve as a liaison
between the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
VerDate Sep<11>2014
17:49 Apr 02, 2015
Jkt 235001
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations should include a
cover letter and a current curriculum
vitae or resume for each nominee,
including a current business and/or
home address, telephone number, and
email address if available, and a list of
consumer or community-based
organizations for which the candidate
can demonstrate active participation.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Nominations should also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation that the nominee is aware
of the nomination, unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
voting or nonvoting consumer
representatives will not participate in
the selection process.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07605 Filed 4–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0929]
Agency Forms Undergoing Paperwork
Reduction Act Review
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
E:\FR\FM\03APN1.SGM
03APN1
18239
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
comments should be received within 30
days of this notice.
Proposed Project
World Trade Center Health Program
Petition for the Addition of a New WTCRelated Health Condition for Coverage
under the World Trade Center (WTC)
Health Program (OMB No. 0920–0929,
expiration 04/30/2015)—Revision—
Centers for Disease Control and
Prevention (CDC), National Institutes for
Occupational Safety and Health
(NIOSH).
Background and Brief Description
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347), amended the Public
Health Service Act (PHS Act) to add
Title XXXIII establishing the WTC
Health Program within the Department
of Health and Human Services (HHS).
The WTC Health Program provides
medical monitoring and treatment
benefits to eligible firefighters and
related personnel, law enforcement
officers, and rescue, recovery, and
cleanup workers who responded to the
September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons who were
present in the dust or dust cloud on
September 11, 2001 or who worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area (survivors).
PHS Act § 3312(a)(3) identifies a list
of health conditions for which
individuals who are enrolled in the
WTC Health Program may be monitored
or treated. PHS Act § 3312(a)(6)(B)
specifies that interested parties may
petition the Administrator of the WTC
Health Program to request that a new
health condition be added to the List of
WTC-Related Health Conditions in 42
CFR 88.1. To aid the petitioner, the
WTC Health Program provides a
petition form to be completed and then
sent to the Administrator for review.
However, the petitioner is not required
to use the form, and may submit a
petition in a different format, provided
it contains all of the data elements
requested on the form.
Data elements include the interested
party’s name, contact information,
signature, and a statement about the
medical basis for the relationship/
association between the 9/11 exposure
and the proposed health condition,
which the Administrator of the WTC
Health Program will use to determine
whether to propose a rule to add the
condition, to not to add the condition,
or to seek a recommendation from the
Scientific/Technical Advisory
Committee (STAC).
The petition form is amended slightly
to reflect a WTC Health Program policy
change. The current form asks
respondents to offer reference to ‘‘a
peer-reviewed, published,
epidemiologic study.’’ The revised form
will ask respondents to reference ‘‘peerreviewed, published, epidemiologic
and/or direct observational studies.’’
The submission of a petition is purely
voluntary, and is not required or
otherwise compelled by NIOSH or the
WTC Health Program.
NIOSH expects to receive no more
than 20 submissions annually.
Petitioners include prospective and
enrolled WTC responders, screeningeligible survivors, certified-eligible
survivors, or members of groups who
advocate on behalf of responders or
survivors, such as physicians. It is
estimated that an individual spends an
average of 40 hours gathering
information to substantiate a request to
add a health condition and assembling
the petition. The total estimated
annualized burden hours are 800.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Responder/Survivor/Advocate (physician) ......
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–07670 Filed 4–2–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2010–D–0566]
Residual Solvents in Animal Drug
Products; Questions and Answers;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
VerDate Sep<11>2014
17:49 Apr 02, 2015
Number of
respondents
Form name
Jkt 235001
Petition for the addition of health conditions
availability of a guidance for industry
#211 entitled ‘‘Residual Solvents in
Animal Drug Products; Questions and
Answers.’’ The questions and answers
guidance addresses the United States
Pharmacopeia (USP) General Chapter
<467> Residual Solvents that applies to
both human and veterinary drugs and to
compendial and non-compendial drug
products. This document answers
questions regarding the Center for
Veterinary Medicine’s (CVM)
implementation of USP <467> Residual
Solvents.
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
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
20
1
Average
burden per
response
(hours)
40
the SUPPLEMENTARY INFORMATION section
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:
Heather Longstaff, Center for Veterinary
Medicine (HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0651,
email: heather.longstaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 3,
2010 (75 FR 75482), FDA published the
notice of availability for a draft guidance
entitled ‘‘Residual Solvents in Animal
Drug Products; Questions and Answers’’
giving interested persons until February
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18238-18239]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0929]
Agency Forms Undergoing Paperwork Reduction Act Review
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
[[Page 18239]]
comments should be received within 30 days of this notice.
Proposed Project
World Trade Center Health Program Petition for the Addition of a
New WTC-Related Health Condition for Coverage under the World Trade
Center (WTC) Health Program (OMB No. 0920-0929, expiration 04/30/
2015)--Revision--Centers for Disease Control and Prevention (CDC),
National Institutes for Occupational Safety and Health (NIOSH).
Background and Brief Description
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
to add Title XXXIII establishing the WTC Health Program within the
Department of Health and Human Services (HHS). The WTC Health Program
provides medical monitoring and treatment benefits to eligible
firefighters and related personnel, law enforcement officers, and
rescue, recovery, and cleanup workers who responded to the September
11, 2001, terrorist attacks in New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders), and to eligible persons who
were present in the dust or dust cloud on September 11, 2001 or who
worked, resided, or attended school, childcare, or adult daycare in the
New York City disaster area (survivors).
PHS Act Sec. 3312(a)(3) identifies a list of health conditions for
which individuals who are enrolled in the WTC Health Program may be
monitored or treated. PHS Act Sec. 3312(a)(6)(B) specifies that
interested parties may petition the Administrator of the WTC Health
Program to request that a new health condition be added to the List of
WTC-Related Health Conditions in 42 CFR 88.1. To aid the petitioner,
the WTC Health Program provides a petition form to be completed and
then sent to the Administrator for review. However, the petitioner is
not required to use the form, and may submit a petition in a different
format, provided it contains all of the data elements requested on the
form.
Data elements include the interested party's name, contact
information, signature, and a statement about the medical basis for the
relationship/association between the 9/11 exposure and the proposed
health condition, which the Administrator of the WTC Health Program
will use to determine whether to propose a rule to add the condition,
to not to add the condition, or to seek a recommendation from the
Scientific/Technical Advisory Committee (STAC).
The petition form is amended slightly to reflect a WTC Health
Program policy change. The current form asks respondents to offer
reference to ``a peer-reviewed, published, epidemiologic study.'' The
revised form will ask respondents to reference ``peer-reviewed,
published, epidemiologic and/or direct observational studies.''
The submission of a petition is purely voluntary, and is not
required or otherwise compelled by NIOSH or the WTC Health Program.
NIOSH expects to receive no more than 20 submissions annually.
Petitioners include prospective and enrolled WTC responders, screening-
eligible survivors, certified-eligible survivors, or members of groups
who advocate on behalf of responders or survivors, such as physicians.
It is estimated that an individual spends an average of 40 hours
gathering information to substantiate a request to add a health
condition and assembling the petition. The total estimated annualized
burden hours are 800.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Responder/Survivor/Advocate Petition for the 20 1 40
(physician). addition of health
conditions.
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-07670 Filed 4-2-15; 8:45 am]
BILLING CODE 4163-18-P
