83 FR 11539 - Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Professional Survey of Professional Prescription Drug Promotion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 51 (March 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 51 (March 15, 2018)
| Page Range | 11539-11542 | |
| FR Document | 2018-05235 |
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)] [Notices] [Pages 11539-11542] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05235] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0215] Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Professional Survey of Professional Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Health Care Professional Survey of Professional Prescription Drug Promotion.'' This study will examine how health care professionals experience and perceive prescription drug promotion directed to them. DATES: Submit either electronic or written comments on the collection of information by May 14, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 14, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-0215 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Professional Survey of Professional Prescription Drug Promotion.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed [[Page 11540]] in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Health Care Professional Survey of Professional Prescription Drug Promotion OMB Control Number 0910--NEW Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. As part of its federal mandate, FDA regulates whether direct-to- consumer (DTC) advertising of prescription drug products is truthful, balanced, and accurately communicated (see 21 U.S.C. 352(n)). Similarly, the FD&C Act prohibits the dissemination of false or misleading information about medications in consumer-directed and professional prescription drug promotion. FDA regulates within the framework of free speech and due process principles of the United States Constitution. To inform current and future policies, and to seek to enhance audience comprehension, the Office of Prescription Drug Promotion conducts research focusing on (1) advertising features including content and format, (2) target populations, and (3) research quality. This proposed research focuses on the physician target population. FDA surveyed physicians about their attitudes toward DTC advertising and its role in their relationships with their patients in 2002 (Ref. 1) and again in 2013 (Refs. 2 and 3). The 2013 survey included multiple types of prescribers: Primary care physicians, specialists, nurse practitioners, and physician assistants. Whereas the focus of both previous FDA surveys was on DTC advertising and promotion, the current study is designed to address issues related to professional prescription drug promotion. The goal is to query a representative sample of health care professionals (HCPs) about their opinions of promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. We will also take this opportunity to ask HCPs briefly about their knowledge of abuse-deterrent formulations for opioid products. To educate themselves about prescription drugs, HCPs sometimes rely on professionally directed promotional information (Refs. 4-8). In 2012, pharmaceutical companies spent more than $24 billion on marketing to physicians (Ref. 9). The industry exposes health care professionals to promotional materials through a variety of mechanisms, including communication with pharmaceutical representatives, journal ads, prescribing software, presentations at sponsored meetings, and direct mail ads (Ref. 10). Several studies indicate that data presented in promotional materials may not be fully comprehended and may even potentially be misleading due to a variety of causes, such as insufficient information, unsupported claims, or a failure to disclose limitations of the information presented (Refs. 11-15). Although HCPs are learned intermediaries, like most people, they may rely on heuristics in making decisions and may have cognitive biases in the type of information they attend to at any given time. They may be persuaded by strong statements and may not have the time to ascertain accuracy of such information (Ref. 16). The proposed survey will provide further insights about how professionally targeted prescription drug promotion might influence health care professionals' decision-making processes and practices and how [[Page 11541]] information may be communicated more effectively. It is important to note that FDA does not regulate the practice of medicine. However, as previously mentioned, FDA does regulate prescription drug promotion. This survey is designed to inform FDA of various responses to and impacts of prescription drug promotion of prescription drugs. The general research questions in the survey are as follows: 1. What methods and/or channels are used to disseminate prescription drug promotional information to health care professionals/ prescribers? 2. How knowledgeable and interested are HCPs in clinical trial data and its presence in prescription drug promotion? 3. How familiar are HCPs with the FDA approval of prescription drugs and how does this translate into practice? In addition, given the critical nature of the opioid situation in the United States at this time, we plan to ask several questions about prescription drug promotion of opioid products. HCPs who fall into one of four categories will be recruited online through WebMD's Medscape subscriber network. We propose to complete 700 primary care physician, 600 specialist, 350 nurse practitioner, and 350 physician assistant surveys. HCPs will be included if they see patients at least 50 percent of the time. Both Doctors of Medicine and Doctors of Osteopathy will be included. Primary care physicians will include those who indicate they work in general, family, or internal medicine. Specialties were chosen based on prevalence in the United States and prescription drug promotional activity. Specialists will include cardiologists, dermatologists, endocrinologists, neurologists, obstetrician/gynecologists, oncologists, ophthalmologists, psychiatrists, rheumatologists, and urologists. The data will be weighted to adjust for differential coverage of select characteristics such as region and respondent age and gender. Pretesting with 25 respondents will take place before the main study to evaluate the procedures and measures used in the main study. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Pretest Study ---------------------------------------------------------------------------------------------------------------- HCP screener.................. 63 1 63 0.08 (5 minutes) 5 Informed Consent.............. 25 1 25 0.08 (5 minutes) 2 HCP Survey.................... 25 1 25 0.33 (20 8 minutes). ---------------------------------------------------------------------------------------------------------------- Main Study ---------------------------------------------------------------------------------------------------------------- HCP screener.................. 5,037 1 5,037 0.08 (5 minutes) 403 Informed Consent.............. 2,000 1 2,000 0.08 (5 minutes) 160 HCP Survey.................... 2,000 1 2,000 0.33 (20 660 minutes). --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 1,238 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs and maintenance costs associated with this collection of information. II. References The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm. Last accessed January 26, 2018. 2. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al. (2016). ``Healthcare Professional Social Media Membership and Participation: Findings From a Nationally Representative Sample,'' Journal of the American Association of Nurse Practitioners. Doi: 10.1002/2327- 6924.12383. 3. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al. (2015). ``Awareness of FDA's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings,'' Journal of Health Communication, vol. 20(11), pp. 1330-1336. 4. Crigger, N.J. (2005). ``Pharmaceutical Promotions and Conflict of Interest in Nurse Practitioner's Decision Making: The Undiscovered Country,'' Journal of the American Academy of Nurse Practitioners, vol. 17(6), pp. 207-212. 5. Fischer, M.A., M.E. Keough, J.L. Baril, et al. (2009). ``Prescribers and Pharmaceutical Representatives: Why Are We Still Meeting?'' Journal of General Internal Medicine, vol. 24(7), pp. 795-801. 6. C. Robertson, S. Rose, and A.S. Kesselheim. (2012). ``Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence,'' The Journal of Law, Medicine & Ethics, vol. 40(3), pp. 452-466. 7. Srivastava, V., M. Handa, and A. Vohra. (2014). ``Promotional Tools: Do Physicians Really Bite the Hook?'' Drishtikon: A Management Journal, vol. 5(2). 8. Austad, K.E., J. Avorn, J.M. Franklin, et al. (2014). ``Association of Marketing Interactions With Medical Trainees' Knowledge About Evidence-Based Prescribing: Results From a National Survey,'' JAMA Internal Medicine, vol. 174(8), pp. 1283-1290. 9. Cegedim Strategic Data. (2013). ``2012 U.S. Pharmaceutical Company Promotion Spending.'' Available at: http://www.skainfo.com/health_care_market_reports/2012_promotional_spending.pdf. 10. Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al. (2010). ``Information From Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review,'' PLoS Medicine, vol. 7(10), e1000352. doi: 10.1371/ jounal.pmed. 1000352. 11. Villanueva, P., S. Peir[oacute], J. Librero, et al. (2003). ``Accuracy of Pharmaceutical Advertisements in Medical Journals,'' Lancet, vol. 361(9351), pp. 27-32. 12. Cooper, R.J. and D.L. Schriger. (2005). ``The Availability of References and the Sponsorship of Original Research Cited in Pharmaceutical Advertisements,'' Canadian Medical Association Journal, vol. 172(4), pp. 487-491. 13. Jureidini, J.N., L.B. McHenry, and P.R. Mansfield. (2008). ``Clinical Trials and Drug Promotion: Selective Reporting of [[Page 11542]] Study 329,'' International Journal of Risk & Safety in Medicine, vol. 20(1-2), pp. 73-81. 14. Garcia-Retamero, R. and M. Galesic. (2010). ``Who Profits From Visual Aids: Overcoming Challenges in People's Understanding of Risks,'' Social Science & Medicine, vol. 70(7), pp. 1019-1025. 15. Cooper, R.J., D.L. Schriger, R.C. Wallace, et al. (2003). ``The Quantity and Quality of Scientific Graphs in Pharmaceutical Advertisements,'' Journal of General Internal Medicine, vol. 18(4), pp. 294-297. 16. Sah, S. and A. Fugh-Berman. (2013). ``Physicians Under the Influence: Social Psychology and Industry Marketing Strategies,'' The Journal of Law, Medicine & Ethics, vol. 41(3), pp. 665-672. doi: 10.1111/jlme.12076. Dated: March 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05235 Filed 3-14-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices 11539
concerning each proposed collection of covered outpatient drugs. This pricing considered. Electronic comments must
information, including each proposed benchmark is based on drug acquisition be submitted on or before May 14, 2018.
extension or reinstatement of an existing costs collected directly from pharmacies The https://www.regulations.gov
collection of information, before through a nationwide survey process. electronic filing system will accept
submitting the collection to OMB for This survey is conducted on a monthly comments until midnight Eastern Time
approval. To comply with this basis to ensure that the NADAC at the end of May 14, 2018. Comments
requirement, CMS is publishing this reference file remains current and up-to- received by mail/hand delivery/courier
notice. date. Form Number: CMS–10241 (OMB (for written/paper submissions) will be
Information Collection control number 0938–1041); Frequency: considered timely if they are
Monthly; Affected Public: Private sector postmarked or the delivery service
1. Type of Information Collection (Business or other for-profits); Number acceptance receipt is on or before that
Request: Revision of a currently of Respondents: 30,000; Total Annual date.
approved collection; Title of Responses: 30,000; Total Annual Hours:
Information Collection: Annual Report Electronic Submissions
15,000. (For policy questions regarding
on Home and Community Based this collection contact: Lisa Shochet at Submit electronic comments in the
Services Waivers and Supporting 410–786–5445.) following way:
Regulations; Use: We use this report to • Federal eRulemaking Portal:
compare actual data to the approved Dated: March 12, 2018.
https://www.regulations.gov. Follow the
waiver estimates. In conjunction with William N. Parham, III, instructions for submitting comments.
the waiver compliance review reports, Director, Paperwork Reduction Staff, Office Comments submitted electronically,
the information provided will be of Strategic Operations and Regulatory including attachments, to https://
compared to that in the Medicaid Affairs.
www.regulations.gov will be posted to
Statistical Information System (MSIS) [FR Doc. 2018–05296 Filed 3–14–18; 8:45 am] the docket unchanged. Because your
(CMS–R–284; OMB control number BILLING CODE 4120–01–P comment will be made public, you are
0938–0345) report and FFP claimed on solely responsible for ensuring that your
a state’s Quarterly Expenditure Report comment does not include any
(CMS–64; OMB control number 0938– DEPARTMENT OF HEALTH AND confidential information that you or a
1265), to determine whether to continue HUMAN SERVICES third party may not wish to be posted,
the state’s home and community-based such as medical information, your or
services waiver. States’ estimates of cost Food and Drug Administration
anyone else’s Social Security number, or
and utilization for renewal purposes are [Docket No. FDA–2018–N–0215] confidential business information, such
based upon the data compiled in the as a manufacturing process. Please note
CMS–372(S) reports. Form Number: Agency Information Collection that if you include your name, contact
CMS–372(S) (OMB control number: Activities; Proposed Collection; information, or other information that
0938–0272); Frequency: Yearly; Affected Comment Request; Health Care identifies you in the body of your
Public: State, Local, or Tribal Professional Survey of Professional comments, that information will be
Governments; Number of Respondents: Prescription Drug Promotion posted on https://www.regulations.gov.
47; Total Annual Responses: 282; Total
AGENCY: Food and Drug Administration, • If you want to submit a comment
Annual Hours: 12,126. (For policy with confidential information that you
HHS.
questions regarding this collection do not wish to be made available to the
contact Ralph Lollar at 410–786–0777). ACTION: Notice.
public, submit the comment as a
2. Type of Information Collection written/paper submission and in the
SUMMARY: The Food and Drug
Request: Extension of a currently manner detailed (see ‘‘Written/Paper
Administration (FDA, Agency, or we) is
approved collection; Title of Submissions’’ and ‘‘Instructions’’).
announcing an opportunity for public
Information Collection: Survey of Retail
comment on the proposed collection of Written/Paper Submissions
Prices; Use: This information collection
certain information by the Agency.
request provides for a survey of the Submit written/paper submissions as
Under the Paperwork Reduction Act of
average acquisition costs of all covered follows:
1995 (PRA), Federal Agencies are
outpatient drugs purchased by retail • Mail/Hand delivery/Courier (for
community pharmacies. CMS may required to publish notice in the
written/paper submissions): Dockets
contract with a vendor to conduct Federal Register concerning each
Management Staff (HFA–305), Food and
monthly surveys of retail prices for proposed collection of information,
Drug Administration, 5630 Fishers
covered outpatient drugs. Such prices including each proposed extension of an
Lane, Rm. 1061, Rockville, MD 20852.
represent a nationwide average of existing collection of information, and • For written/paper comments
consumer purchase prices, net of to allow 60 days for public comment in submitted to the Dockets Management
discounts and rebates. The contractor response to the notice. This notice Staff, FDA will post your comment, as
shall provide notification when a drug solicits comments on ‘‘Health Care well as any attachments, except for
product becomes generally available Professional Survey of Professional information submitted, marked and
and that the contract include such terms Prescription Drug Promotion.’’ This identified, as confidential, if submitted
and conditions as the Secretary shall study will examine how health care as detailed in ‘‘Instructions.’’
specify, including a requirement that professionals experience and perceive Instructions: All submissions received
the vendor monitor the marketplace. prescription drug promotion directed to must include the Docket No. FDA–
sradovich on DSK3GMQ082PROD with NOTICES
CMS has developed a National Average them. 2018–N–0215 for ‘‘Agency Information
Drug Acquisition Cost (NADAC) for DATES: Submit either electronic or Collection Activities; Proposed
states to consider when developing written comments on the collection of Collection; Comment Request; Health
reimbursement methodology. The information by May 14, 2018. Care Professional Survey of Professional
NADAC is a pricing benchmark that is ADDRESSES: You may submit comments Prescription Drug Promotion.’’ Received
based on the national average costs that as follows. Please note that late, comments, those filed in a timely
pharmacies pay to acquire Medicaid untimely filed comments will not be manner (see ADDRESSES), will be placed
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![11542 Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
Study 329,’’ International Journal of Risk ACTION: Announcing Budget Period Nearly 26 million people received
& Safety in Medicine, vol. 20(1–2), pp. Extensions with Funding for the Health accessible, affordable, quality primary
73–81. Center Program. health care services through the Health
14. Garcia-Retamero, R. and M. Galesic. Center Program award recipients in
(2010). ‘‘Who Profits From Visual Aids: SUMMARY: HRSA provided additional 2016.
Overcoming Challenges in People’s grant funds during extended budget
Understanding of Risks,’’ Social Science periods to prevent interruptions in the Approximately one-third of Health
& Medicine, vol. 70(7), pp. 1019–1025. provision of critical health care services Center Program award recipients’
15. Cooper, R.J., D.L. Schriger, R.C. Wallace, for funded service areas until new service areas are competed each year,
et al. (2003). ‘‘The Quantity and Quality awards could be made to eligible and each competition has the potential
of Scientific Graphs in Pharmaceutical Service Area Competition (SAC) to result in a change in award recipient.
Advertisements,’’ Journal of General applicants or HRSA could conduct an SACs are also held prior to the current
Internal Medicine, vol. 18(4), pp. 294– orderly phase-out of Health Center grant’s project period end date when (1)
297. Program activities by the current award a grant is voluntarily relinquished, or (2)
16. Sah, S. and A. Fugh-Berman. (2013). recipients. a program noncompliance enforcement
‘‘Physicians Under the Influence: Social SUPPLEMENTARY INFORMATION: action taken by HRSA terminates the
Psychology and Industry Marketing Recipients of the Award: Health grant. If the SAC draws no fundable
Strategies,’’ The Journal of Law, Center Program award recipients for applications, HRSA may extend the
Medicine & Ethics, vol. 41(3), pp. 665– service areas that were threatened with current award recipient’s budget period
672. doi: 10.1111/jlme.12076. a lapse in services due to service area re- to ensure primary health care services
Dated: March 9, 2018. announcement or transitioning award remain available while a new
Leslie Kux, recipients, as listed in Table 1. competition is conducted for the service
Amount of Non-Competitive Awards: area.
Associate Commissioner for Policy.
33 awards for $17,248,966. The amount of additional grant funds
[FR Doc. 2018–05235 Filed 3–14–18; 8:45 am]
Period of Supplemental Funding: is calculated by pro-rating HRSA’s
BILLING CODE 4164–01–P Fiscal years 2016 and 2017. annual funding commitment to the
CFDA Number: 93.224 service area. Approximately 6 months is
DEPARTMENT OF HEALTH AND Authority: Section 330 of the Public required to announce and conduct a
Health Service Act, as amended (42 U.S.C. SAC and select a new award recipient.
HUMAN SERVICES 254b, as amended). In all cases, current fiscal year funds are
Health Resources and Services Justification: Targeting the nation’s used to extend the award recipient’s
Administration high need populations and geographic existing budget period award. Through
areas, the Health Center Program these actions, award recipients receive
Health Center Program currently funds nearly 1,400 health consistent levels of funding to support
centers that operate more than 11,000 uninterrupted primary health care
AGENCY: Health Resources and Services service delivery sites in every state, the services to the nation’s underserved
Administration (HRSA), Department of District of Columbia, Puerto Rico, the populations and communities during
Health and Human Services (HHS). Virgin Islands, and the Pacific Basin. service area award recipient transition.
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Extension Award amount
Grant number Award recipient name award date ($)
H80CS06641 ................................... Ko’olauloa Community Health and Wellness Center, Inc ......................... 12/01/15 235,116
H80CS26606 ................................... Horizon Health and Wellness, Inc ............................................................. 12/23/15 182,771
H80CS26604 ................................... Neighborhood Outreach Access to Health ............................................... 12/23/15 192,815
H80CS00851 ................................... Duval County Health Department ............................................................. 01/11/16 480,066
H80CS26560 ................................... East Central Missouri Behavioral Health Services, Inc. ........................... 01/15/16 281,845
H80CS00048 ................................... Santa Cruz County .................................................................................... 01/15/16 672,655
H80CS00001 ................................... City of Springfield, Massachusetts ............................................................ 01/15/16 606,761
H80CS00384 ................................... Monroe County Health Center .................................................................. 01/15/16 640,737
H80CS26631 ................................... La Casa de Salud, Inc .............................................................................. 01/15/16 563,753
H80CS00400 ................................... Circle Family Healthcare Network, Inc ...................................................... 01/22/16 501,296
H80CS00013 ................................... Covenant House (Under 21) ..................................................................... 02/03/16 279,116
H80CS26632 ................................... Whitman-Walker Clinic, Inc ....................................................................... 02/06/16 423,273
H80CS00054 ................................... Metropolitan Development Council ........................................................... 02/06/16 457,843
H80CS00055 ................................... White Bird Clinic ........................................................................................ 02/10/16 412,985
H80CS26587 ................................... Saint Hope Foundation ............................................................................. 02/10/16 229,491
H80CS26620 ................................... Korean Health, Education, Information and Research Center ................. 02/12/16 504,386
H80CS26513 ................................... FirstMed Health and Wellness Center ...................................................... 02/12/16 596,025
H80CS08770 ................................... Health Center of Southeast Texas ............................................................ 02/12/16 737,066
H80CS00872 ................................... Madison County Community Health Center ............................................. 03/01/16 467,855
H80CS00622 ................................... The Hunter Health Clinic, Inc .................................................................... 03/08/16 450,569
sradovich on DSK3GMQ082PROD with NOTICES
H80CS10606 ................................... St. Vincent de Paul Village, Inc ................................................................ 04/06/16 334,418
H80CS06078 ................................... Yakima Neighborhood Health Services .................................................... 04/06/16 1,025,892
H80CS17251 ................................... Upper Room Aids Ministry, Inc. Health Care Center ................................ 04/06/16 738,043
H80CS00722 ................................... Community Clinic of Maui, Inc .................................................................. 04/06/16 570,042
H80CS01443 ................................... Lane County .............................................................................................. 05/15/16 649,218
H80CS00054 ................................... Metropolitan Development Council ........................................................... 06/14/16 228,922
H80CS00299 ................................... Brazos Valley Community Action Agency, Inc .......................................... 01/17/17 1,520,645
H80CS00814 ................................... Kalihi-Palama Health Center ..................................................................... 01/17/17 1,105,506
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Document Created: 2018-03-15 02:37:43
Document Modified: 2018-03-15 02:37:43
| 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 | Submit either electronic or written comments on the collection of information by May 14, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 11539 |
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