81 FR 53489 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Program Application Forms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 156 (August 12, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 156 (August 12, 2016)
| Page Range | 53489-53491 | |
| FR Document | 2016-19301 |
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)] [Notices] [Pages 53489-53491] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19301] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Program Application Forms AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. DATES: Comments on this ICR should be received no later than September 12, 2016. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Health Center Program Application Forms OMB No. 0915-0285--Revision. Abstract: Health centers (those entities funded under Public Health Service Act section 330 and Health Center Program look-alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. Health centers are an essential primary care provider for America's most vulnerable populations. Health centers provide [[Page 53490]] coordinated, comprehensive, and patient-centered primary and preventive health care. Nearly 1,400 health centers operate more than 9,800 service delivery sites that provide care in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. The Health Center Program is administered by HRSA's Bureau of Primary Health Care (BPHC). BPHC uses multiple Health Center Program- specific forms (see table below) to oversee the Health Center Program. Need and Proposed Use of the Information: Health Center Program- specific forms are critical to Health Center Program grant and non- grant award processes and for Health Center Program oversight. The purpose of these forms is to provide HRSA staff and objective review committee panels information essential for application evaluation, funding recommendation, approval, designation, and monitoring. These forms also provide HRSA staff with information essential for ensuring compliance with Health Center Program legislative and regulatory requirements. These application forms are used by existing health centers and other organizations to apply for various grant and non- grant opportunities, renew their grant or non-grant designation, and change their scope of project. Most of the Health Center Program-specific forms do not require any significant changes with this revision. HRSA intends to revise some of the forms to streamline and clarify data already being requested (Form 1A, 1B, 2, 3, 5A, 5B, 6A, 8, Performance Measures, Project Work Plan, Outreach and Enrollment Progress Report) and change several form names (changing Form 3A to Look-Alike Budget Information, Form 10 to Emergency Preparedness Report, and Increased Demand for Services to Expanded Services). HRSA also intends to add seven new forms. The Supplemental Information form and Summary Page will consolidate important application information that is usually found distributed throughout the application, including eligibility criteria and projected goals. These forms will require applicant confirmation that the information provided is accurate. Two of these new forms will include the Program Narrative Update, used to report progress for renewal of Health Center Program awards, and the Substance Abuse Progress Report, used to report quarterly progress for award recipients of Substance Abuse Expansion supplemental funding. Two other forms, the Health Center Controlled Networks Work Plan and Progress Report, are forms that have been used in the past (under another OMB control number) to collect application baseline data and progress metrics for grantees. An additional new form, Zika Progress Report, will collect quarterly progress on Zika-related projects. Likely Respondents: Health Center Program award recipients and look-alikes, state and national technical assistance organizations, and other organizations seeking funding. 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 ICR are summarized in the table below. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total Form name respondents responses per responses response burden respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- Form 1A: General Information Worksheet..... 1,700 1 1,700 1.0 1,700 Form 1B: BPHC Funding Request Summary...... 450 1 450 0.75 337.5 Form 1C: Documents on File................. 1,000 1 1,000 0.5 500 Form 2: Staffing Profile................... 1,700 1 1,700 1.0 1,700 Form 3: Income Analysis.................... 1,900 1 1,900 2.5 4,750 Form 3A: Look-Alike Budget Information..... 100 1 100 1.0 100 Form 4: Community Characteristics.......... 1,000 1 1,000 1.0 1,000 Form 5A: Services Provided................. 1,700 1 1,700 1.0 1,700 Form 5B: Service Sites..................... 1,200 1 1,200 0.75 900 Form 5C: Other Activities/Locations........ 1,000 1 1,000 0.5 500 Form 6A: Current Board Member 1,000 1 1,000 0.5 500 Characteristics........................... Form 6B: Request for Waiver of Governance 100 1 100 1.0 100 Requirements.............................. Form 8: Health Center Agreements........... 600 1 600 0.75 450 Form 9: Need for Assistance Worksheet...... 500 1 500 4.5 2,250 Form 10: Emergency Preparedness Report..... 1,000 1 1,000 1.0 1,000 Form 12: Organization Contacts............. 1,000 1 1,000 0.5 500 Clinical Performance Measures.............. 1,000 1 1,000 3.5 3,500 Financial Performance Measures............. 1,000 1 1,000 1.0 1,000 Implementation Plan........................ 900 1 900 3.0 2,700 Project Work Plan.......................... 200 1 200 5.0 1,000 Proposal Cover Page........................ 400 1 400 1.0 400 Project Cover Page......................... 400 1 400 1.0 400 Equipment List............................. 400 1 400 1.0 400 Other Requirements for Sites............... 400 1 400 0.5 200 Funding Sources............................ 400 1 400 0.5 200 Project Qualification Criteria............. 400 1 400 1.0 400 O&E Supplemental........................... 1,200 1 1,200 1.0 1,200 O&E Progress Report........................ 1,200 1 1,200 1.0 1,200 Checklist for Adding a New Service Delivery 700 1 700 1.5 1,050 Site...................................... Checklist for Deleting Existing Service 700 1 700 1.0 700 Delivery Site............................. [[Page 53491]] Checklist for Adding New Service........... 700 1 700 1.0 700 Checklist for Deleting Existing Service.... 700 1 700 1.0 700 Checklist for Adding a New Target 50 1 50 0.5 25 Population................................ Expanded Services.......................... 1,400 1 1,400 1.0 1,400 Federal Object Class Categories............ 1,400 1 1,400 0.25 350 Supplemental Information (NEW)............. 2,000 1 2,000 0.5 1,000 Summary Page (NEW)......................... 1,700 1 1,700 0.25 425 Program Narrative Update (NEW)............. 900 1 900 4.0 3,600 Substance Abuse Progress Report (NEW)...... 300 4 1,200 1.0 1,200 Health Center Controlled Networks Progress 93 1 93 25 2,325 Report (NEW).............................. Health Center Controlled Networks Work Plan 93 1 93 5.0 465 (NEW)..................................... Zika Progress Report (NEW)................. 20 4 80 1.0 80 -------------------------------------------------------------------- Total.................................. 34,606 .............. 35,566 ........... 44,608 ---------------------------------------------------------------------------------------------------------------- Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-19301 Filed 8-11-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices 53489
guidance no longer cites the Redbook, are especially interested in fda.gov/Food/GuidanceRegulation/
we continue to recommend the use of recommendations for clearer examples GuidanceDocumentsRegulatory
the dietary exposure assessment or criteria to differentiate changes in Information/IngredientsAdditivesGRAS
Packaging/ucm2006826.htm.
methodology and some toxicology tests manufacturing methods and starting
that are also used for the evaluation of materials that alter the identity of the Dated: August 9, 2016.
food additives because these are ingredient from changes that do not. Jeremy Sharp,
standard scientific methods not specific • What processes ‘‘chemically alter’’ Deputy Commissioner for Policy, Planning,
to any particular safety assessment an ingredient within the meaning of Legislation, and Analysis.
paradigm. Finally, we added a new section 413(a)(1) of the FD&C Act, and [FR Doc. 2016–19306 Filed 8–11–16; 8:45 am]
question at the end of section VI.C to why? Conversely, what processes do not BILLING CODE 4164–01–P
emphasize that this draft guidance cause chemical alteration, and why? Are
contains recommendations about safety there certain processes, such as
information to include in an NDI tinctures, that sometimes result in DEPARTMENT OF HEALTH AND
notification, but these recommendations chemical alteration and sometimes do HUMAN SERVICES
are not requirements. not? What criteria should be used to
• Other changes—We made clarifying evaluate whether an ingredient has been Health Resources and Services
changes, explanatory changes, and chemically altered? We are especially Administration
editorial changes throughout the interested in receiving scientific
document. We also updated references information that shows whether a Agency Information Collection
and links and added new references particular process actually results in Activities: Submission to OMB for
where appropriate. chemical alteration. Review and Approval; Public Comment
• What method of compiling Request; Health Center Program
II. Paperwork Reduction Act of 1995 Application Forms
independent and verifiable data on the
Under the Paperwork Reduction Act marketing of dietary ingredients before AGENCY: Health Resources and Services
of 1995 (the PRA) (44 U.S.C. 3501– October 15, 1994, would be most Administration, HHS.
3520), Federal agencies must obtain effective? How should an authoritative ACTION: Notice.
approval from the Office of Management list of ‘‘grandfathered’’ ingredients
and Budget (OMB) for each collection of based on such data be developed and SUMMARY: In compliance with Section
information they conduct or sponsor. implemented? 3507(a)(1)(D) of the Paperwork
This draft guidance contains proposed As FDA considers the development of Reduction Act of 1995, the Health
collections of information. ‘‘Collection final guidance, we will review Resources and Services Administration
of information’’ is defined in 44 U.S.C. comments received on this revised (HRSA) has submitted an Information
3502(3) and 5 CFR 1320.3(c) and version, as well as comments on the Collection Request (ICR) to the Office of
includes Agency requests or 2011 draft guidance that are still Management and Budget (OMB) for
requirements that members of the public relevant. review and approval. Comments
submit reports, keep records, or provide submitted during the first public review
information to a third party. Section IV. Electronic Access
of this ICR will be provided to OMB.
3506(c)(2)(A) of the PRA (44 U.S.C. Persons with access to the Internet OMB will accept further comments from
3506(c)(2)(A)) requires Federal Agencies may obtain the guidance at either http:// the public during the review and
to publish a 60-day notice in the www.fda.gov/FoodGuidances or http:// approval period.
Federal Register soliciting public www.regulations.gov. Use the FDA Web DATES: Comments on this ICR should be
comment on each proposed collection of site listed in the previous sentence to received no later than September 12,
information before submitting the find the most current version of the 2016.
collection to OMB for approval. To draft guidance.
ADDRESSES: Submit your comments,
comply with this requirement, we V. References
intend to publish a 60-day notice on the including the ICR Title, to the desk
proposed collections of information in The following references are on officer for HRSA, either by email to
this draft guidance in a future issue of display in the Division of Dockets OIRA_submission@omb.eop.gov or by
the Federal Register. Management (see ADDRESSES) and are fax to 202–395–5806.
This draft guidance also refers to available for viewing by interested FOR FURTHER INFORMATION CONTACT: To
previously approved collections of persons between 9 a.m. and 4 p.m., request a copy of the clearance requests
information found in FDA regulations. Monday through Friday; they are also submitted to OMB for review, email the
These collections of information are available electronically at http:// HRSA Information Collection Clearance
subject to review by OMB under the www.regulations.gov. FDA has verified Officer at paperwork@hrsa.gov or call
PRA. The collections of information in the Web site addresses, as of the date (301) 443–1984.
21 CFR part 111 have been approved this document publishes in the Federal SUPPLEMENTARY INFORMATION:
under OMB control number 0901–0606, Register, but Web sites are subject to Information Collection Request Title:
and the collections of information in change over time. Health Center Program Application
§ 190.6 have been approved under OMB 1. International Programme on Chemical Forms OMB No. 0915–0285—Revision.
control number 0910–0330. Safety, ‘‘Principles and Methods for the Abstract: Health centers (those
Risk Assessment of Chemicals in Food,’’ entities funded under Public Health
III. Other Issues for Consideration Environmental Health Criteria 240 Service Act section 330 and Health
mstockstill on DSK3G9T082PROD with NOTICES
Although FDA welcomes comments (2009), available at: http://www.who.int/ Center Program look-alikes) deliver
on any aspect of this draft guidance, we foodsafety/publications/chemical-food/ comprehensive, high quality, cost-
en/. effective primary health care to patients
particularly invite comment on the 2. The official name of the Redbook is
following: ‘‘Guidance for Industry and Other regardless of their ability to pay. Health
• What processes alter the identity of Stakeholders: Toxicological Principles centers are an essential primary care
an ingredient marketed prior to October for the Safety Assessment of Food provider for America’s most vulnerable
15, 1994, and thus create an NDI? We Ingredients,’’ available at: http://www. populations. Health centers provide
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![Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices 53491
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Average
Number of Total
Number of Total burden per
Form name responses per burden
respondents responses response
respondent hours
(in hours)
Checklist for Adding New Service ....................................................... 700 1 700 1.0 700
Checklist for Deleting Existing Service ................................................ 700 1 700 1.0 700
Checklist for Adding a New Target Population ................................... 50 1 50 0.5 25
Expanded Services .............................................................................. 1,400 1 1,400 1.0 1,400
Federal Object Class Categories ......................................................... 1,400 1 1,400 0.25 350
Supplemental Information (NEW) ........................................................ 2,000 1 2,000 0.5 1,000
Summary Page (NEW) ........................................................................ 1,700 1 1,700 0.25 425
Program Narrative Update (NEW) ....................................................... 900 1 900 4.0 3,600
Substance Abuse Progress Report (NEW) ......................................... 300 4 1,200 1.0 1,200
Health Center Controlled Networks Progress Report (NEW) ............. 93 1 93 25 2,325
Health Center Controlled Networks Work Plan (NEW) ....................... 93 1 93 5.0 465
Zika Progress Report (NEW) ............................................................... 20 4 80 1.0 80
Total .............................................................................................. 34,606 ........................ 35,566 .................... 44,608
Jason E. Bennett, Name of Committee: National Institute of The meeting will be closed to the
Director, Division of the Executive Secretariat. Biomedical Imaging and Bioengineering public in accordance with the
[FR Doc. 2016–19301 Filed 8–11–16; 8:45 am]
Special Emphasis Panel; 2017–01 R25 provisions set forth in sections
Application Review. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
BILLING CODE 4165–15–P
Date: September 28, 2016.
Time: 10:00 a.m. to 4:00 p.m.
as amended. The grant applications and
Agenda: To review and evaluate grant the discussions could disclose
DEPARTMENT OF HEALTH AND applications. confidential trade secrets or commercial
HUMAN SERVICES Place: National Institutes of Health, Two property such as patentable material,
Democracy Plaza, Suite 920, 6707 Democracy and personal information concerning
National Institutes of Health Boulevard, Bethesda, MD 20892, (Virtual individuals associated with the grant
Meeting). applications, the disclosure of which
National Institute of Biomedical Contact Person: Ruixia Zhoua, Ph.D., would constitute a clearly unwarranted
Imaging and Bioengineering; Notice of Scientific Review Officer, 6707 Democracy invasion of personal privacy.
Closed Meetings Boulevard, Democracy Two Building, Suite
957, Bethesda, MD 20892, (301) 496–473, Name of Committee: National Arthritis and
Pursuant to section 10(d) of the zhour@mail.nih.gov. Musculoskeletal and Skin Diseases Advisory
Federal Advisory Committee Act, as Council.
Dated: August 8, 2016.
amended (5 U.S.C. App.), notice is Date: September 13, 2016.
hereby given of the following meetings. David Clary, Open: 8:30 a.m. to 12:00 p.m.
The meetings will be closed to the Program Analyst, Office of Federal Advisory Agenda: Discussion of program policies.
public in accordance with the Committee Policy. Place: National Institutes of Health,
provisions set forth in sections [FR Doc. 2016–19191 Filed 8–11–16; 8:45 am] Building 31, 31 Center Drive, 6th Floor, C
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P Wing, Conference Room 6, Bethesda, MD
as amended. The grant applications and 20892.
Closed: 1:00 p.m. to 4:00 p.m.
the discussions could disclose
DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant
confidential trade secrets or commercial applications.
property such as patentable material, HUMAN SERVICES
Place: National Institutes of Health,
and personal information concerning Building 31, 31 Center Drive, 6th Floor, C
individuals associated with the grant National Institutes of Health
Wing, Conference Room 6, Bethesda, MD
applications, the disclosure of which National Institute of Arthritis and 20892.
would constitute a clearly unwarranted Musculoskeletal and Skin Diseases;
Contact Person: Laura K. Moen, Ph.D.,
invasion of personal privacy. Director, Division of Extramural Research
Notice of Meeting Activities, NIAMS/NIH, 6700 Democracy
Name of Committee: National Institute of Boulevard, Suite 800, Bethesda, MD 20892,
Biomedical Imaging and Bioengineering Pursuant to section 10(d) of the 301–451–6515, moenl@mail.nih.gov.
Special Emphasis Panel; Rapid Assessment Federal Advisory Committee Act, as Any interested person may file written
of Zika Virus Complications (2017/01). amended (5 U.S.C. App.), notice is
Date: September 12, 2016. comments with the committee by forwarding
hereby given of a meeting of the the statement to the Contact Person listed on
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
National Arthritis and Musculoskeletal this notice. The statement should include the
applications. and Skin Diseases Advisory Council. name, address, telephone number and when
Place: National Institutes of Health, Two The meeting will be open to the applicable, the business or professional
Democracy Plaza, Suite 920, 6707 Democracy public as indicated below, with affiliation of the interested person.
mstockstill on DSK3G9T082PROD with NOTICES
Boulevard, Bethesda, MD 20892, (Telephone attendance limited to space available. In the interest of security, NIH has
Conference Call). instituted stringent procedures for entrance
Individuals who plan to attend and onto the NIH campus. All visitor vehicles,
Contact Person: Dennis Hlasta, Ph.D., need special assistance, such as sign
Scientific Review Officer, National Institute including taxicabs, hotel, and airport shuttles
of Biomedical Imaging and Bioengineering, language interpretation or other will be inspected before being allowed on
National Institutes of Health, 6707 reasonable accommodations, should campus. Visitors will be asked to show one
Democracy Blvd., Bethesda, MD 20892, (301) notify the Contact Person listed below form of identification (for example, a
451–4794, dennis.hlasta@nih.gov. in advance of the meeting. government-issued photo ID, driver’s license,
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Document Created: 2018-02-09 11:33:29
Document Modified: 2018-02-09 11:33:29
| 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 ICR should be received no later than September 12, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 53489 |
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