Agency Information Collection Activities; Proposed Collection; Comment Request, 13687-13688 [2013-04723]

Download as PDF 13687 Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Notices FDASIA). In addition, when pediatric studies under PREA are fully or partially waived by FDA because there is evidence that a drug would be ineffective or unsafe in a pediatric population or pediatric subpopulation, the safety concern or lack of efficacy must be reflected in the prescription drug labeling (section 505B(a)(4)(D) of the FD&C Act). All useful information on the use of drugs and biological products in the pediatric population should be consistently placed in the proper sections within prescription labeling so that the information is clear and accessible to health care providers. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on incorporating pediatric information into human prescription drug and biological products labeling. 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 requirements of the applicable statutes and regulations. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or http:// www.regulations.gov. Dated: February 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04625 Filed 2–27–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: II. The Paperwork Reduction Act of 1995 Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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 Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s SUMMARY: This guidance refers to previously approved collections of information that 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 201.56 and 201.57 have been approved under OMB control number 0910–0572. III. Comments Interested persons may submit either electronic comments regarding this document to http://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. 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. Information Collection Request Title: The Health Education Assistance Loan (HEAL) Program Regulations (OMB No. 0915–0108)—Extension Abstract: The Health Education Assistance Loan (HEAL) Program has regulations that contain notification, reporting, and recordkeeping requirements to insure that the lenders and holders participating in the HEAL program follow sound management procedures in the administration of federally-insured student loans. While the regulatory requirements are approved under the OMB number referenced above, much of the burden associated with the regulations is cleared under separate OMB numbers for the HEAL forms and electronic submissions used to report required information. The table below provides the estimate of burden for the remaining regulations. 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 review instructions, to 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, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: REPORTING REQUIREMENTS mstockstill on DSK4VPTVN1PROD with NOTICES Number of respondents Number of transactions Total transactions Hours per response (min) Total burden hours 13 Holders ....................................................................................................... 0 Schools ......................................................................................................... 4 0 52 0 12 0 10.40 0 Total Reporting ......................................................................................... ........................ ........................ ........................ 10.40 VerDate Mar<15>2010 19:12 Feb 27, 2013 Jkt 229001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\28FEN1.SGM 28FEN1 13688 Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Notices NOTIFICATION REQUIREMENTS Number of respondents Number of transactions Total transactions Hours per response (min) Total burden hours 15,000 Borrowers ............................................................................................ 13 Holders ....................................................................................................... 0 Schools ......................................................................................................... 1 6,500 0 15,000 84,500 0 10 10 0 2,500.00 14,083.33 0 Total Notification ....................................................................................... ........................ ........................ ........................ 16,583.33 RECORDKEEPING REQUIREMENTS Number of respondents Number of transactions Total transactions Hours per response (min) 13 Holders ....................................................................................................... 0 Schools ......................................................................................................... Total Recordkeeping ................................................................................ 2,600 0 ........................ 33,800 0 ........................ 14 0 ........................ 7,886.67 0 7,886.67 Total Burden Hours .................................................................................. ........................ ........................ ........................ 24,480.40 Submit your comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Deadline: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Dated: February 21, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–04723 Filed 2–27–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration mstockstill on DSK4VPTVN1PROD with NOTICES National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its seventy-second meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Time: April 3, 2013, 9:00 a.m.–5:00 p.m. April 4, 2013, 9:00 a.m.– 5:00 p.m. April 5, 2013, 8:45 a.m.–11:15 a.m. Place: Hospice & Palliative Care of Western Colorado, 3090 North 12th Street, Unit B, Grand Junction, CO 81506, Web site: www.hospicewco.com. Phone: (970) 241–2212. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human VerDate Mar<15>2010 19:12 Feb 27, 2013 Jkt 229001 Services provides advice and recommendations to the Secretary with respect to the delivery, research, development, and administration of health and human services in rural areas. Agenda: Wednesday morning, at 9:00 a.m., the meeting will be called to order by the Chairman of the Committee, the Honorable Ronnie Musgrove. The Committee will be examining hospice and palliative care for rural patients and efforts to ameliorate rural poverty. The day will conclude with a period of public comment at approximately 5:00 p.m. Thursday morning, at approximately 9:00 a.m., the Committee will break into Subcommittees and depart for site visits to rural healthcare and human services providers in Colorado. One panel from the Health Subcommittee will visit Family Health West Hospital in Fruita, CO. Another panel from the Health Subcommittee will visit Plateau Valley Clinic in Collbran, CO. The Human Services Subcommittee will visit Montrose County Health and Human Services in Montrose, Colorado. The day will conclude at the Doubletree Hilton Grand Junction with a period of public comment at approximately 5:00 p.m. The final session will be convened on Friday morning at 9:00 a.m. The Committee will summarize key findings from the meeting and develop a work plan for the next quarter and the following meeting. The meeting will adjourn at 11:15 a.m. For Further Information Contact: Steve Hirsch, MSLS, Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Total burden hours Room 5A–05, 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 443–0835, Fax (301) 443–2803. Persons interested in attending any portion of the meeting should contact Nathan Nash at the Office of Rural Health Policy (ORHP) via telephone at (301) 443–0835 or by email at nnash@hrsa.gov. The Committee meeting agenda will be posted on ORHP’s Web site http://www.hrsa.gov/ advisorycommittees/rural/. Dated: February 21, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–04652 Filed 2–27–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the SUMMARY: E:\FR\FM\28FEN1.SGM 28FEN1

Agencies

[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13687-13688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. 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 Reports Clearance Officer at (301) 443-1984.
    HRSA especially 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.

Information Collection Request Title: The Health Education Assistance 
Loan (HEAL) Program Regulations (OMB No. 0915-0108)--Extension

    Abstract: The Health Education Assistance Loan (HEAL) Program has 
regulations that contain notification, reporting, and recordkeeping 
requirements to insure that the lenders and holders participating in 
the HEAL program follow sound management procedures in the 
administration of federally-insured student loans. While the regulatory 
requirements are approved under the OMB number referenced above, much 
of the burden associated with the regulations is cleared under separate 
OMB numbers for the HEAL forms and electronic submissions used to 
report required information. The table below provides the estimate of 
burden for the remaining regulations.
    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 review 
instructions, to 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, to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information, and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

                                             Reporting Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                     Hours per
             Number of  respondents                  Number of         Total         response      Total burden
                                                   transactions    transactions        (min)           hours
----------------------------------------------------------------------------------------------------------------
13 Holders......................................               4              52              12           10.40
0 Schools.......................................               0               0               0               0
                                                 ---------------------------------------------------------------
    Total Reporting.............................  ..............  ..............  ..............           10.40
----------------------------------------------------------------------------------------------------------------


[[Page 13688]]


                                            Notification Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                     Hours per
             Number of  respondents                  Number of         Total         response      Total burden
                                                   transactions    transactions        (min)           hours
----------------------------------------------------------------------------------------------------------------
15,000 Borrowers................................               1          15,000              10        2,500.00
13 Holders......................................           6,500          84,500              10       14,083.33
0 Schools.......................................               0               0               0               0
                                                 ---------------------------------------------------------------
    Total Notification..........................  ..............  ..............  ..............       16,583.33
----------------------------------------------------------------------------------------------------------------


                                           Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                     Hours per
             Number of  respondents                  Number of         Total         response      Total burden
                                                   transactions    transactions        (min)           hours
----------------------------------------------------------------------------------------------------------------
13 Holders......................................           2,600          33,800              14        7,886.67
0 Schools.......................................               0               0               0               0
    Total Recordkeeping.........................  ..............  ..............  ..............        7,886.67
                                                 ---------------------------------------------------------------
    Total Burden Hours..........................  ..............  ..............  ..............       24,480.40
----------------------------------------------------------------------------------------------------------------


ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20857.
    Deadline: Comments on this Information Collection Request must be 
received within 60 days of this notice.

    Dated: February 21, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-04723 Filed 2-27-13; 8:45 am]
BILLING CODE 4165-15-P