Agency Information Collection Activities: Proposed Collection: Public Comment Request, 9268-9269 [2015-03526]
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Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices
Submit written requests for
single copies of the draft guidance to the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 The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://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: Lori
J. Churchyard, 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:
TKELLEY on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Investigating
and Reporting Adverse Reactions
Related to Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps) Regulated Solely Under
Section 361 of the Public Health Service
Act and 21 CFR part 1271’’ dated
February 2015. The draft guidance
document is intended provide
manufacturers of HCT/Ps, with
recommendations for complying with
the requirements for investigating and
reporting adverse reactions involving
communicable disease in recipients of
HCT/Ps that are regulated solely under
section 361 of the Public Health Service
Act (42 U.S.C. 264) and 21 CFR part
1271 (361 HCT/Ps).
The draft guidance, when finalized, is
intended to supplement section XXII of
FDA’s guidance entitled ‘‘Guidance for
Industry: Current Good Tissue Practice
(CGTP) and Additional Requirements
for Manufacturers of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ dated December
2011 by providing additional
recommendations specific to the
responsibilities to investigate
complaints of adverse reactions
concerning 361 HCT/Ps under
§§ 1271.160(b)(2), 1271.320 and
1271.350(a)(1).
The draft guidance, when finalized, is
intended to supersede the guidance
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17:07 Feb 19, 2015
Jkt 235001
entitled ‘‘Guidance for Industry:
MedWatch Form FDA 3500A:
Mandatory Reporting of Adverse
Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ dated November
2005. The guidance will provide
updated information specific to
reporting adverse reactions related to
HCT/Ps to supplement the general
instructions accompanying the
MedWatch mandatory reporting form,
Form FDA 3500A.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent 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 public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft 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 part 1271 have been
approved under OMB control number
0910–0543 and OMB control number
0910–0291.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. 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 draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
PO 00000
Frm 00009
Fmt 4703
Sfmt 4703
Dated: February 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03490 Filed 2–19–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than April 21, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail to the
HRSA Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Radiation Exposure Screening and
Education Program OMB No. 0915–
xxxx—New.
Abstract: The Radiation Exposure
Screening and Education Program
(RESEP) is authorized by section 417C
of the Public Health Service Act (42
U.S.C. 285a–9). The purpose of RESEP
is to assist individuals who live (or
lived) in areas where U.S. nuclear
weapons testing occurred and who are
SUMMARY:
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Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices
diagnosed with cancer and other
radiogenic diseases caused by exposure
to nuclear fallout or nuclear materials
such as uranium. RESEP funds support
eligible health care organizations in
implementing cancer screening
programs; developing education
programs; disseminating information on
radiogenic diseases and the importance
of early detection; screening eligible
individuals for cancer and other
radiogenic diseases; providing
appropriate referrals for medical
treatment; and facilitating
documentation of Radiation Exposure
Compensation Act (RECA) claims.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993 (Pub. L.
103–62). These measures cover the
principal topic areas of interest to the
Federal Office of Rural Health Policy,
including: (a) Demographics for the
RESEP program medical user patient
population; (b) medical screening
activities for cancers and other
radiogenic diseases; (c) exposure and
presentation types for eligible
radiogenic malignant and nonmalignant diseases; (d) referrals for
appropriate medical treatment; (e)
eligibility counseling and referral
assistance for the RECA and Energy
Employees Occupational Illness
Compensation Act programs; and (f)
program outreach and education
activities. These measures will speak to
the Office’s progress toward meeting the
goals set.
Likely Respondents: Radiation
Exposure Screening and Education
Program award recipients.
Number of
respondents
Form name
Number of
responses per
respondent
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to: (1) Review instructions; (2)
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; (3) train
personnel and to be able to respond to
a collection of information; (4) search
data sources; to complete and review
the collection of information; and (5)
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Radiation Exposure Screening and Education Program
Performance Measures ....................................................
50
1
50
24
1,200
Total ..............................................................................
50
1
50
24
1,200
HRSA specifically requests comments
on: (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.
Jackie Painter,
Director, Division of the Executive Secretariat.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
SUMMARY:
[FR Doc. 2015–03526 Filed 2–19–15; 8:45 am]
Comments on this ICR should be
received no later than March 23, 2015.
BILLING CODE 4165–15–P
ADDRESSES:
Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
TKELLEY on DSK3SPTVN1PROD with NOTICES
DATES:
To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
SUPPLEMENTARY INFORMATION:
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
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Information Collection Request Title:
The Secretary’s Discretionary Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
PO 00000
Frm 00010
Fmt 4703
Sfmt 4703
System Assessment Surveys OMB No.
0906–xxxx—New.
Abstract: The purpose of the public
health system assessment surveys is to
inform the Secretary’s Discretionary
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee) on the ability to add
newborn screening for particular
conditions within a state, including the
feasibility, readiness, and overall
capacity to screen for a new condition.
The Committee was established under
the Public Health Service Act, 42 U.S.C.
217a: Advisory Councils or Committees.
This Committee fulfills the functions
previously undertaken by the former
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children, established under section
1111 of the Public Health Service Act
(PHS), 42 U.S.C. 300b–10, as amended
in the Newborn Screening Saves Lives
Act of 2008. The Committee is governed
by the provisions of the Federal
Advisory Committee Act (FACA), as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
purpose of the Committee is to provide
the Secretary with recommendations,
advice, and technical information
regarding the most appropriate
application of technologies, policies,
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[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Notices]
[Pages 9268-9269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than April 21, 2015.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail to the
HRSA Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Radiation Exposure Screening
and Education Program OMB No. 0915-xxxx--New.
Abstract: The Radiation Exposure Screening and Education Program
(RESEP) is authorized by section 417C of the Public Health Service Act
(42 U.S.C. 285a-9). The purpose of RESEP is to assist individuals who
live (or lived) in areas where U.S. nuclear weapons testing occurred
and who are
[[Page 9269]]
diagnosed with cancer and other radiogenic diseases caused by exposure
to nuclear fallout or nuclear materials such as uranium. RESEP funds
support eligible health care organizations in implementing cancer
screening programs; developing education programs; disseminating
information on radiogenic diseases and the importance of early
detection; screening eligible individuals for cancer and other
radiogenic diseases; providing appropriate referrals for medical
treatment; and facilitating documentation of Radiation Exposure
Compensation Act (RECA) claims.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data useful to the program
and to enable HRSA to provide aggregate program data required by
Congress under the Government Performance and Results Act (GPRA) of
1993 (Pub. L. 103-62). These measures cover the principal topic areas
of interest to the Federal Office of Rural Health Policy, including:
(a) Demographics for the RESEP program medical user patient population;
(b) medical screening activities for cancers and other radiogenic
diseases; (c) exposure and presentation types for eligible radiogenic
malignant and non-malignant diseases; (d) referrals for appropriate
medical treatment; (e) eligibility counseling and referral assistance
for the RECA and Energy Employees Occupational Illness Compensation Act
programs; and (f) program outreach and education activities. These
measures will speak to the Office's progress toward meeting the goals
set.
Likely Respondents: Radiation Exposure Screening and Education
Program award recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to: (1) Review
instructions; (2) develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; (3) train personnel and to be able to respond to
a collection of information; (4) search data sources; to complete and
review the collection of information; and (5) transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Radiation Exposure Screening and 50 1 50 24 1,200
Education Program Performance
Measures.......................
-------------------------------------------------------------------------------
Total....................... 50 1 50 24 1,200
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (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.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-03526 Filed 2-19-15; 8:45 am]
BILLING CODE 4165-15-P
