81 FR 27452 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 88 (May 6, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 88 (May 6, 2016)
| Page Range | 27452-27453 | |
| FR Document | 2016-10635 |
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)] [Notices] [Pages 27452-27453] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10635] ----------------------------------------------------------------------- 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 [email protected] 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 [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. [[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
![27452 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
that is required for submissions to the Pharmacy Compounding Advisory CONTACT). In light of the fact that no
SRDP and providing a streamlined and Committee. The committee is a change has been made to the committee
standardized format for the presentation discretionary Federal advisory name or description of duties, no
of the required information. Form committee established to provide advice amendment will be made to 21 CFR
Number: CMS–10328 (OMB control to the Commissioner. The Pharmacy 14.100.
number: 0938–1106); Frequency: Compounding Advisory Committee This document is issued under the
Annually and semi-annually; Affected advises the Commissioner or designee Federal Advisory Committee Act (5
Public: Private sector (Business or other in discharging responsibilities as they U.S.C. app.). For general information
for-profits and Not-for-profits); Number relate to compounded drugs for human related to FDA advisory committees,
of Respondents: 200; Total Annual use and, as required, any other product please visit us at http://www.fda.gov/
Responses: 200; Total Annual Hours: for which the Food and Drug AdvisoryCommittees/default.htm.
5,000. (For policy questions regarding Administration has regulatory Dated: April 29, 2016.
this collection contact Matt Edgar at responsibility. Jill Hartzler Warner,
410–786–0698.) The Committee shall provide advice
Associate Commissioner for Special Medical
on scientific, technical, and medical Programs.
Dated: May 3, 2016.
issues concerning drug compounding
William N. Parham, III, [FR Doc. 2016–10585 Filed 5–5–16; 8:45 am]
under sections 503A and 503B of the
Director, Paperwork Reduction Staff, Office Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P
of Strategic Operations and Regulatory (21 U.S.C. 353a) and (21 U.S.C. 353b),
Affairs.
and, as required, any other product for DEPARTMENT OF HEALTH AND
[FR Doc. 2016–10705 Filed 5–5–16; 8:45 am] which the Food and Drug HUMAN SERVICES
BILLING CODE 4120–01–P Administration has regulatory
responsibility, and make appropriate Health Resources and Services
recommendations to the Commissioner Administration
DEPARTMENT OF HEALTH AND of Food and Drugs.
HUMAN SERVICES The Committee shall consist of a core Agency Information Collection
of 12 voting members including the Activities: Proposed Collection: Public
Food and Drug Administration
Chair. Members and the Chair are Comment Request
[Docket No. FDA–2013–N–1687] selected by the Commissioner or
designee from among authorities AGENCY: Health Resources and Services
Advisory Committee; Pharmacy knowledgeable in the fields of Administration, HHS.
Compounding Advisory Committee, pharmaceutical compounding, ACTION: Notice.
Renewal pharmaceutical manufacturing, SUMMARY: In compliance with the
AGENCY: Food and Drug Administration, pharmacy, medicine, and related requirement for opportunity for public
HHS. specialties. These members will include comment on proposed data collection
representatives from the National projects (section 3506(c)(2)(A) of the
ACTION:Notice; renewal of advisory Association of Boards of Pharmacy, the
committee. Paperwork Reduction Act of 1995), the
United States Pharmacopeia, Health Resources and Services
SUMMARY: The Food and Drug pharmacists with current experience Administration (HRSA) announces
Administration (FDA) is announcing the and expertise in compounding, plans to submit an Information
renewal of the Pharmacy Compounding physicians with background and Collection Request (ICR), described
Advisory Committee by the knowledge in compounding, and patient below, to the Office of Management and
Commissioner of Food and Drugs (the and public health advocacy Budget (OMB). Prior to submitting the
Commissioner). The Commissioner has organizations. Members will be invited ICR to OMB, HRSA seeks comments
determined that it is in the public to serve for overlapping terms of up to from the public regarding the burden
interest to renew the Pharmacy 4 years. Almost all non-Federal estimate, below, or any other aspect of
Compounding Advisory Committee for members of this committee serve as the ICR.
an additional 2 years beyond the charter Special Government Employees. The
DATES: Comments on this Information
expiration date. The new charter will be core of voting members may include one
Collection Request must be received no
in effect until April 25, 2018. or more technically qualified members,
later than July 5, 2016.
selected by the Commissioner or
DATES: Authority for the Pharmacy ADDRESSES: Submit your comments to
designee, who are identified with
Compounding Advisory Committee will consumer interests and are paperwork@hrsa.gov or mail the HRSA
expire on April 25, 2016, unless the recommended by either a consortium of Information Collection Clearance
Commissioner formally determines that consumer-oriented organizations or Officer, Room 14N–39, Parklawn
renewal is in the public interest. other interested persons. In addition to Building, 5600 Fishers Lane, Rockville,
FOR FURTHER INFORMATION CONTACT: the voting members, the Committee may MD 20857.
Cindy Hong, Center for Drug Evaluation include one or more non-voting FOR FURTHER INFORMATION CONTACT: To
and Research, Food and Drug members who are identified with request more information on the
Administration, 10903 New Hampshire industry interests. proposed project or to obtain a copy of
Ave., Bldg. 31, Rm. 2417, Silver Spring, Further information regarding the the data collection plans and draft
asabaliauskas on DSK3SPTVN1PROD with NOTICES
MD 20993–0002, 301–796–9001, most recent charter and other instruments, email paperwork@hrsa.gov
PCAC@fda.hhs.gov. information can be found at http:// or call the HRSA Information Collection
SUPPLEMENTARY INFORMATION: Pursuant www.fda.gov/AdvisoryCommittees/ Clearance Officer at (301) 443–1984.
to 41 CFR 102–3.65 and approval by the CommitteesMeetingMaterials/Drugs/ SUPPLEMENTARY INFORMATION: When
Department of Health and Human PharmacyCompoundingAdvisory submitting comments or requesting
Services pursuant to 45 CFR part 11 and Committee/ucm381305.htm or by information, please include the
by the General Services Administration, contacting the Designated Federal information request collection title for
FDA is announcing the renewal of the Officer (see FOR FURTHER INFORMATION reference.
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![Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices 27453
Information Collection Request Title: relevant to the Health Center Program admissible projects will include: (1)
Data Use Agreement and Supplement using up-to-date information. Relevance of the topic of study to
for 2014 Health Center Patient Survey. Prior to releasing information from BPHC/HHS policy; (2) feasibility of the
OMB No.: 0915–xxxx–New. the survey, BPHC will request project given the parameters described
Abstract: The Health Center Patient prospective users to complete the ‘‘Data in DUA supplemental; and (3) the
Survey (HCPS), sponsored by the Health Use Agreement’’ (DUA). BPHC uses proposed end-use of the research that
Resources and Services DUAs as legal binding agreements when will be undertaken.
Administration’s (HRSA) Bureau of an external entity (e.g., contractor,
Primary Health Care (BPHC), surveys Likely Respondents: Prospective
private industry, academic institution,
patients who use health centers funded researchers in academia, private
other federal government agency, or
under Section 330 of the Public Health contractors, and Primary Care
state agency) requests the use of BPHC
Service Act. HCPS collects data on personally/organizationally identifiable Associations/Health Center Program
health center patients’ data that is covered by the Privacy Act grantee organizations.
sociodemographic characteristics, of 1974. The agreement delineates the Burden Statement: Burden in this
health conditions, health behaviors, confidentiality requirements of the context means the time expended by
access to and utilization of health care Privacy Act, security safeguards, and persons to generate, maintain, retain,
services, and satisfaction with their BPHC’s data use policies and disclose or provide the information
health care. Survey results come from procedures. The DUA will serve as both requested. This includes the time
in-person, one-on-one interviews with a means of informing data users of these needed to review instructions; to
patients and are nationally requirements and a means of obtaining develop, acquire, install and utilize
representative of the Health Center their agreement to abide by these technology and systems for the purpose
Program patient population. To inform requirements. of collecting, validating and verifying
BPHC and HHS policy, funding, and Need and Proposed Use of the information, processing and
planning decisions, the survey Information: Before allowing access to maintaining information, and disclosing
investigated how well HRSA-supported unrestricted data that contains sensitive and providing information; to train
sites meet health care needs of the grantee and patient information that is personnel and to be able to respond to
medically underserved and assessed protected by the Privacy Act of 1974, a collection of information; to search
how patients perceive the quality of prospective users will submit a signed data sources; to complete and review
their care. HCPS is unique because it DUA and describe what proposed the collection of information; and to
focused on comprehensive patient-level research they intend to undertake in transmit or otherwise disclose the
data. These and other features of the using the dataset. A BPHC workgroup information. The total annual burden
data will provide researchers and will determine whether the project is an hours estimated for this Information
policymakers the capacity to appropriate and legitimate use of the Collection Request are summarized in
empirically explore policy topics data. The criteria to determine the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
DUA ...................................................................................... 20 1 20 0.25 5
DUA Supplemental .............................................................. 20 1 20 1.25 25
Total .............................................................................. 40 ........................ 40 ........................ 30
HRSA specifically requests comments DEPARTMENT OF HEALTH AND applications, the disclosure of which
on (1) the necessity and utility of the HUMAN SERVICES would constitute a clearly unwarranted
proposed information collection for the invasion of personal privacy.
proper performance of the agency’s National Institutes of Health
Name of Committee: Molecular, Cellular
functions, (2) the accuracy of the and Developmental Neuroscience Integrated
Center for Scientific Review; Notice of
estimated burden, (3) ways to enhance Review Group; Neurogenesis and Cell Fate
Closed Meetings
the quality, utility, and clarity of the Study Section.
information to be collected, and (4) the Pursuant to section 10(d) of the Date: June 1, 2016.
use of automated collection techniques Federal Advisory Committee Act, as Time: 9:00 a.m. to 8:00 p.m.
or other forms of information amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant
technology to minimize the information applications.
hereby given of the following meetings.
Place: Hyatt Regency Crystal City, 2799
collection burden. The meetings will be closed to the Jefferson Davis Highway, Arlington, VA
public in accordance with the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Jackie Painter, 22202.
provisions set forth in sections Contact Person: Joanne T Fujii, Ph.D.,
Director, Division of the Executive Secretariat.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review Officer, Center for
[FR Doc. 2016–10635 Filed 5–5–16; 8:45 am]
as amended. The grant applications and Scientific Review, National Institutes of
BILLING CODE 4165–15–P the discussions could disclose Health, 6701 Rockledge Drive, Room 4184,
confidential trade secrets or commercial MSC 7850, Bethesda, MD 20892, (301) 435–
property such as patentable material, 1178, fujiij@csr.nih.gov.
and personal information concerning Name of Committee: Biological Chemistry
individuals associated with the grant and Macromolecular Biophysics Integrated
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Document Created: 2016-05-06 00:29:36
Document Modified: 2016-05-06 00:29:36
| 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 July 5, 2016. | |
| 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 | 81 FR 27452 |
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