Agency Information Collection Activities: Proposed Collection: Public Comment Request, 27452-27453 [2016-10635]

Download as PDF 27452 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices that is required for submissions to the SRDP and providing a streamlined and standardized format for the presentation of the required information. Form Number: CMS–10328 (OMB control number: 0938–1106); Frequency: Annually and semi-annually; Affected Public: Private sector (Business or other for-profits and Not-for-profits); Number of Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 5,000. (For policy questions regarding this collection contact Matt Edgar at 410–786–0698.) Dated: May 3, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016–10705 Filed 5–5–16; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1687] Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2018. DATES: Authority for the Pharmacy Compounding Advisory Committee will expire on April 25, 2016, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, PCAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 May 05, 2016 Jkt 238001 Pharmacy Compounding Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Pharmacy Compounding Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to compounded drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee shall provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) and (21 U.S.C. 353b), and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee shall consist of a core of 12 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. These members will include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one or more technically qualified members, selected by the Commissioner or designee, who are identified with consumer interests and are recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one or more non-voting members who are identified with industry interests. Further information regarding the most recent charter and other information can be found at http:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ PharmacyCompoundingAdvisory Committee/ucm381305.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: April 29, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–10585 Filed 5–5–16; 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 July 5, 2016. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N–39, 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. SUMMARY: E:\FR\FM\06MYN1.SGM 06MYN1 27453 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices Information Collection Request Title: Data Use Agreement and Supplement for 2014 Health Center Patient Survey. OMB No.: 0915–xxxx–New. Abstract: The Health Center Patient Survey (HCPS), sponsored by the Health Resources and Services Administration’s (HRSA) Bureau of Primary Health Care (BPHC), surveys patients who use health centers funded under Section 330 of the Public Health Service Act. HCPS collects data on health center patients’ sociodemographic characteristics, health conditions, health behaviors, access to and utilization of health care services, and satisfaction with their health care. Survey results come from in-person, one-on-one interviews with patients and are nationally representative of the Health Center Program patient population. To inform BPHC and HHS policy, funding, and planning decisions, the survey investigated how well HRSA-supported sites meet health care needs of the medically underserved and assessed how patients perceive the quality of their care. HCPS is unique because it focused on comprehensive patient-level data. These and other features of the data will provide researchers and policymakers the capacity to empirically explore policy topics relevant to the Health Center Program using up-to-date information. Prior to releasing information from the survey, BPHC will request prospective users to complete the ‘‘Data Use Agreement’’ (DUA). BPHC uses DUAs as legal binding agreements when an external entity (e.g., contractor, private industry, academic institution, other federal government agency, or state agency) requests the use of BPHC personally/organizationally identifiable data that is covered by the Privacy Act of 1974. The agreement delineates the confidentiality requirements of the Privacy Act, security safeguards, and BPHC’s data use policies and procedures. The DUA will serve as both a means of informing data users of these requirements and a means of obtaining their agreement to abide by these requirements. Need and Proposed Use of the Information: Before allowing access to unrestricted data that contains sensitive grantee and patient information that is protected by the Privacy Act of 1974, prospective users will submit a signed DUA and describe what proposed research they intend to undertake in using the dataset. A BPHC workgroup will determine whether the project is an appropriate and legitimate use of the data. The criteria to determine admissible projects will include: (1) Relevance of the topic of study to BPHC/HHS policy; (2) feasibility of the project given the parameters described in DUA supplemental; and (3) the proposed end-use of the research that will be undertaken. Likely Respondents: Prospective researchers in academia, private contractors, and Primary Care Associations/Health Center Program grantee organizations. 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. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Total responses Total burden hours DUA ...................................................................................... DUA Supplemental .............................................................. 20 20 1 1 20 20 0.25 1.25 5 25 Total .............................................................................. 40 ........................ 40 ........................ 30 asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. 2016–10635 Filed 5–5–16; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:20 May 05, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neurogenesis and Cell Fate Study Section. Date: June 1, 2016. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202. Contact Person: Joanne T Fujii, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD 20892, (301) 435– 1178, fujiij@csr.nih.gov. Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Pages 27452-27453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10635]


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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 July 5, 2016.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 14N-39, 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.

[[Page 27453]]

    Information Collection Request Title: Data Use Agreement and 
Supplement for 2014 Health Center Patient Survey.
    OMB No.: 0915-xxxx-New.
    Abstract: The Health Center Patient Survey (HCPS), sponsored by the 
Health Resources and Services Administration's (HRSA) Bureau of Primary 
Health Care (BPHC), surveys patients who use health centers funded 
under Section 330 of the Public Health Service Act. HCPS collects data 
on health center patients' sociodemographic characteristics, health 
conditions, health behaviors, access to and utilization of health care 
services, and satisfaction with their health care. Survey results come 
from in-person, one-on-one interviews with patients and are nationally 
representative of the Health Center Program patient population. To 
inform BPHC and HHS policy, funding, and planning decisions, the survey 
investigated how well HRSA-supported sites meet health care needs of 
the medically underserved and assessed how patients perceive the 
quality of their care. HCPS is unique because it focused on 
comprehensive patient-level data. These and other features of the data 
will provide researchers and policymakers the capacity to empirically 
explore policy topics relevant to the Health Center Program using up-
to-date information.
    Prior to releasing information from the survey, BPHC will request 
prospective users to complete the ``Data Use Agreement'' (DUA). BPHC 
uses DUAs as legal binding agreements when an external entity (e.g., 
contractor, private industry, academic institution, other federal 
government agency, or state agency) requests the use of BPHC 
personally/organizationally identifiable data that is covered by the 
Privacy Act of 1974. The agreement delineates the confidentiality 
requirements of the Privacy Act, security safeguards, and BPHC's data 
use policies and procedures. The DUA will serve as both a means of 
informing data users of these requirements and a means of obtaining 
their agreement to abide by these requirements.
    Need and Proposed Use of the Information: Before allowing access to 
unrestricted data that contains sensitive grantee and patient 
information that is protected by the Privacy Act of 1974, prospective 
users will submit a signed DUA and describe what proposed research they 
intend to undertake in using the dataset. A BPHC workgroup will 
determine whether the project is an appropriate and legitimate use of 
the data. The criteria to determine admissible projects will include: 
(1) Relevance of the topic of study to BPHC/HHS policy; (2) feasibility 
of the project given the parameters described in DUA supplemental; and 
(3) the proposed end-use of the research that will be undertaken.
    Likely Respondents: Prospective researchers in academia, private 
contractors, and Primary Care Associations/Health Center Program 
grantee organizations.
    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.

                                     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)
----------------------------------------------------------------------------------------------------------------
DUA.............................              20               1              20            0.25               5
DUA Supplemental................              20               1              20            1.25              25
                                 -------------------------------------------------------------------------------
    Total.......................              40  ..............              40  ..............              30
----------------------------------------------------------------------------------------------------------------

    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. 2016-10635 Filed 5-5-16; 8:45 am]
 BILLING CODE 4165-15-P