80 FR 9268 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 34 (February 20, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 34 (February 20, 2015)
| Page Range | 9268-9269 | |
| FR Document | 2015-03526 |
[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)] [Notices] [Pages 9268-9269] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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 [email protected] 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
![9268 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices
ADDRESSES: Submit written requests for entitled ‘‘Guidance for Industry: Dated: February 12, 2015.
single copies of the draft guidance to the MedWatch Form FDA 3500A: Leslie Kux,
Office of Communication, Outreach, and Mandatory Reporting of Adverse Associate Commissioner for Policy.
Development, Center for Biologics Reactions Related to Human Cells, [FR Doc. 2015–03490 Filed 2–19–15; 8:45 am]
Evaluation and Research (CBER), Food Tissues, and Cellular and Tissue-Based BILLING CODE 4164–01–P
and Drug Administration, 10903 New Products (HCT/Ps)’’ dated November
Hampshire Ave., Bldg. 71, Rm. 3128, 2005. The guidance will provide
Silver Spring, MD 20993–0002. Send updated information specific to DEPARTMENT OF HEALTH AND
one self-addressed adhesive label to reporting adverse reactions related to HUMAN SERVICES
assist the office in processing your HCT/Ps to supplement the general
requests. The draft guidance may also be instructions accompanying the Health Resources and Services
obtained by mail by calling CBER at 1– MedWatch mandatory reporting form, Administration
800–835–4709 or 240–402–7800. See Form FDA 3500A.
the SUPPLEMENTARY INFORMATION section Agency Information Collection
The draft guidance is being issued
for electronic access to the draft Activities: Proposed Collection: Public
consistent with FDA’s good guidance
guidance document. Comment Request
practices regulation (21 CFR 10.115).
Submit electronic comments on the The draft guidance, when finalized, will AGENCY: Health Resources and Services
draft guidance to http:// represent FDA’s current thinking on this Administration, HHS.
www.regulations.gov. Submit written topic. It does not create or confer any ACTION: Notice.
comments to the Division of Dockets rights for or on any person and does not
Management (HFA–305), Food and Drug operate to bind FDA or the public. An SUMMARY: In compliance with the
Administration, 5630 Fishers Lane, Rm. alternative approach may be used if requirement for opportunity for public
1061, Rockville, MD 20852. such approach satisfies the requirement comment on proposed data collection
FOR FURTHER INFORMATION CONTACT: Lori of the applicable statutes and projects (section 3506(c)(2)(A) of the
J. Churchyard, Center for Biologics regulations. Paperwork Reduction Act of 1995), the
Evaluation and Research, Food and Health Resources and Services
Drug Administration, 10903 New II. Paperwork Reduction Act of 1995 Administration (HRSA) announces
Hampshire Ave., Bldg. 71, Rm. 7301, The draft guidance refers to plans to submit an Information
Silver Spring, MD 20993–0002, 240– previously approved collections of Collection Request (ICR), described
402–7911. information found in FDA regulations. below, to the Office of Management and
SUPPLEMENTARY INFORMATION: These collections of information are Budget (OMB). Prior to submitting the
subject to review by the Office of ICR to OMB, HRSA seeks comments
I. Background
Management and Budget (OMB) under from the public regarding the burden
FDA is announcing the availability of estimate, below, or any other aspect of
the Paperwork Reduction Act of 1995
a draft document entitled ‘‘Investigating the ICR.
(44 U.S.C. 3501–3520). The collections
and Reporting Adverse Reactions DATES: Comments on this Information
of information in part 1271 have been
Related to Human Cells, Tissues, and Collection Request must be received no
approved under OMB control number
Cellular and Tissue-Based Products later than April 21, 2015.
0910–0543 and OMB control number
(HCT/Ps) Regulated Solely Under
0910–0291. ADDRESSES: Submit your comments to
Section 361 of the Public Health Service
paperwork@hrsa.gov or mail to the
Act and 21 CFR part 1271’’ dated III. Comments
HRSA Information Collection Clearance
February 2015. The draft guidance
The draft guidance is being Officer, Room 10–29, Parklawn
document is intended provide
distributed for comment purposes only Building, 5600 Fishers Lane, Rockville,
manufacturers of HCT/Ps, with
and is not intended for implementation MD 20857.
recommendations for complying with
the requirements for investigating and at this time. Interested persons may FOR FURTHER INFORMATION CONTACT: To
reporting adverse reactions involving submit either electronic comments request more information on the
communicable disease in recipients of regarding this document to http:// proposed project or to obtain a copy of
HCT/Ps that are regulated solely under www.regulations.gov or written the data collection plans and draft
section 361 of the Public Health Service comments to the Division of Dockets instruments, email paperwork@hrsa.gov
Act (42 U.S.C. 264) and 21 CFR part Management (see ADDRESSES). It is only or call the HRSA Information Collection
1271 (361 HCT/Ps). necessary to send one set of comments. Clearance Officer at (301) 443–1984.
The draft guidance, when finalized, is Identify comments with the docket SUPPLEMENTARY INFORMATION: When
intended to supplement section XXII of number found in brackets in the submitting comments or requesting
FDA’s guidance entitled ‘‘Guidance for heading of this document. Received information, please include the
Industry: Current Good Tissue Practice comments may be seen in the Division information request collection title for
(CGTP) and Additional Requirements of Dockets Management between 9 a.m. reference.
for Manufacturers of Human Cells, and 4 p.m., Monday through Friday, and Information Collection Request Title:
Tissues, and Cellular and Tissue-Based will be posted to the docket at http:// Radiation Exposure Screening and
Products (HCT/Ps)’’ dated December www.regulations.gov. Education Program OMB No. 0915–
2011 by providing additional IV. Electronic Access xxxx—New.
Abstract: The Radiation Exposure
TKELLEY on DSK3SPTVN1PROD with NOTICES
recommendations specific to the
responsibilities to investigate Persons with access to the Internet Screening and Education Program
complaints of adverse reactions may obtain the draft guidance at either (RESEP) is authorized by section 417C
concerning 361 HCT/Ps under http://www.fda.gov/BiologicsBlood of the Public Health Service Act (42
§§ 1271.160(b)(2), 1271.320 and Vaccines/GuidanceCompliance U.S.C. 285a–9). The purpose of RESEP
1271.350(a)(1). RegulatoryInformation/Guidances/ is to assist individuals who live (or
The draft guidance, when finalized, is default.htm or http:// lived) in areas where U.S. nuclear
intended to supersede the guidance www.regulations.gov. weapons testing occurred and who are
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![Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 9269
diagnosed with cancer and other 103–62). These measures cover the Burden Statement: Burden in this
radiogenic diseases caused by exposure principal topic areas of interest to the context means the time expended by
to nuclear fallout or nuclear materials Federal Office of Rural Health Policy, persons to generate, maintain, retain,
such as uranium. RESEP funds support including: (a) Demographics for the disclose or provide the information
eligible health care organizations in RESEP program medical user patient requested. This includes the time
implementing cancer screening population; (b) medical screening needed to: (1) Review instructions; (2)
programs; developing education activities for cancers and other develop, acquire, install and utilize
programs; disseminating information on radiogenic diseases; (c) exposure and technology and systems for the purpose
radiogenic diseases and the importance presentation types for eligible of collecting, validating and verifying
of early detection; screening eligible radiogenic malignant and non- information, processing and
individuals for cancer and other malignant diseases; (d) referrals for maintaining information, and disclosing
radiogenic diseases; providing appropriate medical treatment; (e) and providing information; (3) train
appropriate referrals for medical eligibility counseling and referral personnel and to be able to respond to
treatment; and facilitating assistance for the RECA and Energy a collection of information; (4) search
documentation of Radiation Exposure Employees Occupational Illness data sources; to complete and review
Compensation Act (RECA) claims. Compensation Act programs; and (f) the collection of information; and (5)
Need and Proposed Use of the
program outreach and education transmit or otherwise disclose the
Information: For this program,
performance measures were drafted to activities. These measures will speak to information. The total annual burden
provide data useful to the program and the Office’s progress toward meeting the hours estimated for this Information
to enable HRSA to provide aggregate goals set. Collection Request are summarized in
program data required by Congress Likely Respondents: Radiation the table below.
under the Government Performance and Exposure Screening and Education Total Estimated Annualized burden
Results Act (GPRA) of 1993 (Pub. L. Program award recipients. hours:
Average
Number of
Number of Total burden per Total
Form name responses per
respondents responses response burden hours
respondent (in 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 SUMMARY: In compliance with section System Assessment Surveys OMB No.
on: (1) The necessity and utility of the 3507(a)(1)(D) of the Paperwork 0906–xxxx—New.
proposed information collection for the Reduction Act of 1995, the Health Abstract: The purpose of the public
proper performance of the agency’s Resources and Services Administration health system assessment surveys is to
functions; (2) the accuracy of the (HRSA) has submitted an Information inform the Secretary’s Discretionary
estimated burden; (3) ways to enhance Collection Request (ICR) to the Office of Advisory Committee on Heritable
the quality, utility, and clarity of the Management and Budget (OMB) for Disorders in Newborns and Children
information to be collected; and (4) the review and approval. Comments (Committee) on the ability to add
use of automated collection techniques submitted during the first public review newborn screening for particular
or other forms of information of this ICR will be provided to OMB. conditions within a state, including the
technology to minimize the information OMB will accept further comments from feasibility, readiness, and overall
collection burden. the public during the review and capacity to screen for a new condition.
approval period. The Committee was established under
Jackie Painter, the Public Health Service Act, 42 U.S.C.
Director, Division of the Executive Secretariat. DATES: Comments on this ICR should be 217a: Advisory Councils or Committees.
received no later than March 23, 2015. This Committee fulfills the functions
[FR Doc. 2015–03526 Filed 2–19–15; 8:45 am]
BILLING CODE 4165–15–P ADDRESSES: Submit your comments, previously undertaken by the former
including the Information Collection Secretary’s Advisory Committee on
Request Title, to the desk officer for Heritable Disorders in Newborns and
DEPARTMENT OF HEALTH AND HRSA, either by email to OIRA_ Children, established under section
HUMAN SERVICES submission@omb.eop.gov or by fax to 1111 of the Public Health Service Act
202–395–5806. (PHS), 42 U.S.C. 300b–10, as amended
Health Resources and Services FOR FURTHER INFORMATION CONTACT: To in the Newborn Screening Saves Lives
Administration request a copy of the clearance requests Act of 2008. The Committee is governed
submitted to OMB for review, email the by the provisions of the Federal
Agency Information Collection Advisory Committee Act (FACA), as
HRSA Information Collection Clearance
Activities: Submission to OMB for
TKELLEY on DSK3SPTVN1PROD with NOTICES
amended (5 U.S.C. App.), which sets
Officer at paperwork@hrsa.gov or call
Review and Approval; Public Comment forth standards for the formation and
(301) 443–1984.
Request use of advisory committees. The
SUPPLEMENTARY INFORMATION: purpose of the Committee is to provide
AGENCY:Health Resources and Services Information Collection Request Title: the Secretary with recommendations,
Administration, HHS. The Secretary’s Discretionary Advisory advice, and technical information
ACTION: Notice. Committee on Heritable Disorders in regarding the most appropriate
Newborns and Children’s Public Health application of technologies, policies,
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Document Created: 2015-12-18 13:01:54
Document Modified: 2015-12-18 13:01:54
| 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. | |
| Dates | Comments on this Information Collection Request must be received no later than April 21, 2015. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 9268 |
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