82 FR 48098 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 198 (October 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 48098-48102 | |
| FR Document | 2017-22344 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Notices] [Pages 48098-48102] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22344] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- [[Page 48099]] SUMMARY: The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by November 15, 2017, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by November 15, 2017. Nominations will be accepted for current vacancies and for those that will or may occur through November 30, 2017. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to [email protected]; by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002; or by Fax: 301-847-8640. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm; by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002; or by Fax: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301-796-8220 email: [email protected]. For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1. Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory Research, Food and Drug Administration, Committee. 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993-0002, phone: 301-796-2721, email: [email protected]. Patricio Garcia, Center for Devices and Clinical Chemistry and Radiological Health, Food and Drug Clinical Toxicology Administration, 10903 New Hampshire Ave., Devices Panel. Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002, phone: 301-796-6875, email: [email protected]. Evella Washington, Center for Devices and Ear, Nose and Throat Radiological Health, Food and Drug Devices Panel, Immunology Administration, 10903 New Hampshire Ave., Devices Panel. Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, phone: 301-796-6683, email: [email protected]. Pamela Scott, Center for Devices and Medical Devices Dispute Radiological Health, Food and Drug Resolution. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993-0002, phone: 301-796-5433, email: [email protected]. Aden Asefa, Center for Devices and Neurological Devices Panel. Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, phone: 301-796-0400, email: [email protected]. LaToya Bonner, Center for Drug Evaluation Endocrinologic and and Research, Food and Drug Metabolic Drugs Advisory Administration, 10903 New Hampshire Ave., Committee. Bldg. 31, Rm. 2428, Silver Spring, MD 20993-0002, phone: 301-796-2855, email: [email protected]. Karen Strambler, Center for Food Safety and Food Advisory Committee. Nutrition, Food and Drug Administration, FDA College Park, CPK1, Rm. 1C008, College Park, MD 20740, phone: 240-402-2589, email: [email protected]. Cindy Chee, Center for Drug Evaluation and Gastrointestinal Drugs Research, Food and Drug Administration, Advisory Committee, 10903 New Hampshire Ave., Bldg. 31, Rm. Pulmonary-Allergy Drugs 2430, Silver Spring, MD 20993-0002, phone: Advisory Committee. 301-796-0889, email: [email protected]. Jennifer Shepherd, Center for Drug Medical Imaging Advisory Evaluation and Research, Food and Drug Committee. Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, phone: 301-796-4043, email: [email protected]. Moon Hee Choi, Center for Drug Evaluation Non-Prescription Drugs and Research, Food and Drug Advisory Committee, Administration, 10903 New Hampshire Ave., Peripheral & Central Bldg. 31, Rm. 2434, Silver Spring, MD Nervous Systems Advisory 20993-0002, phone: 301-796-2894, email: Committee. [email protected]. Marieann Brill, Office of the Commissioner, Pediatrics Advisory Office of Medical Products and Tobacco, Committee. Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993-0002, phone: 240-402- 3838, email: [email protected]. ------------------------------------------------------------------------ SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2. [[Page 48100]] Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed ---------------------------------------------------------------------------------------------------------------- Committee/panel/areas of expertise needed Type of vacancy Approximate date needed ---------------------------------------------------------------------------------------------------------------- Antimicrobial Advisory Committee-- 1--Voting.................. November 30, 2017. Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Clinical Chemistry and Clinical Toxicology 1--Nonvoting............... Immediately. Devices Panel--Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology. Ear, Nose and Throat Devices Panel-- 1--Nonvoting............... Immediately. Otologists, neurologists, and audiologists. Immunology Devices--Persons with experience 1--Nonvoting............... Immediately. in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine. Medical Devices Dispute Resolution--Experts 1--Nonvoting............... Immediately. with broad, cross-cutting scientific, clinical, analytical, or mediation skills. Neurological Devices Panel--Neurosurgeons 1--Nonvoting............... Immediately. (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians. Endocrinologic and Metabolic Drugs Advisory 1--Voting.................. Immediately. Committee--Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Food Advisory Committee--Knowledgeable in 1--Voting.................. Immediately. the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines. Gastrointestinal Drugs Advisory Committee-- 1--Voting.................. Immediately. Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Pulmonary-Allergy Drugs Advisory Committee-- 1--Voting.................. Immediately. Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics. Medical Imaging Advisory Committee-- 1--Voting.................. Immediately. Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. Non-Prescription Drugs Advisory Committee-- 1--Voting.................. Immediately. Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Peripheral and Central Nervous System Drugs 1--Voting.................. Immediately. Advisory Committee--Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties. Pediatrics Advisory Committee-- 1--Voting.................. Immediately. Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/ or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and one representative from a relevant patient or patient-family organization and may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one nonvoting member who is identified with industry interests. ---------------------------------------------------------------------------------------------------------------- I. Functions and General Description of the Committee Duties A. Antimicrobial Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders. B. Certain Panels of the Medical Devices Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area: (1) Advises on the classification or reclassification of devices into one of three regulatory categories; (2) advises on any possible risks to health associated with the use of devices; (3) advises on formulation of product development protocols; (4) reviews premarket approval applications for medical devices; (5) reviews guidelines and guidance documents; (6) recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; (7) advises on the necessity to ban a device; and (8) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions. C. Endocrinologic and Metabolic Drugs Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human [[Page 48101]] drug products for use in the treatment of endocrine and metabolic disorders. D. Food Advisory Committee Make recommendations on emerging food safety, food science, nutrition, and other food-related health issues that FDA considers of primary importance for its food and cosmetics programs. Reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food or cosmetic related issues; (2) the safety of new foods and food ingredients; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. E. Gastrointestinal Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases. F. Pulmonary-Allergy Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms. G. Medical Imaging Drugs Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology. H. Non-Prescription Drugs Advisory Committee Review and evaluate available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advise the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee will serve as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDA's mission and regulatory responsibilities. I. Peripheral and Central Nervous System Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases. J. Pediatrics Advisory Committee The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding: (1) Pediatric research; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric labeling changes; (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur; (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products; (8) research involving children as subjects; and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary of Health and Human Services (Secretary) directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services. II. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate an affiliation with and/or active participation in consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel. IV. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations must include a current, complete r[eacute]sum[eacute] or curriculum vitae for each nominee, a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations must also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to [[Page 48102]] permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: October 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22344 Filed 10-13-17; 8:45 am] BILLING CODE 4164-01-P
![48098 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
sections 514 and 515 of the FD&C Act use of the device outweighs the risk of sections 514 and 515 of the FD&C Act,
(21 U.S.C. 360d and 360e) provided that injury or illness from its use, taking into provided that the device meets
the device: (1) Is designed to treat or account the probable risks and benefits requirements set forth under section
diagnose a disease or condition that of currently available devices or 520(m) of the FD&C Act; and (3)
affects no more than 8,000 individuals alternative forms of treatment. whether to grant marketing approval(s)
in the United States; (2) would not be Respondents may submit a for the HUD. Failure to collect this
available to a person with a disease or humanitarian device exemption (HDE) information would prevent FDA from
condition unless an exemption is application seeking exemption from the making a determination on the factors
effectiveness requirements of sections
granted and there is no comparable listed previously in this document.
514 and 515 of the FD&C Act as
device other than another HUD Further, the collected information
authorized by section 520(m)(2). The
approved under this exemption that is would also enable FDA to determine
information collected will assist FDA in
available to treat or diagnose such making determinations on the whether the holder of an HUD is in
disease or condition; and (3) will not following: (1) Whether to grant HUD compliance with the HUD provisions
expose patients to an unreasonable or designation of a medical device; (2) under section 520(m) of the FD&C Act.
significant risk of illness or injury and whether to exempt an HUD from the FDA estimates the burden of this
the probable benefit to health from the effectiveness requirements under collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Request for HUD designation—814.102 ............................. 19 1 19 40 760
HDE Application—814.104 .................................................. 3 1 3 320 960
HDE Amendments and resubmitted HDEs—814.106 ......... 6 5 30 50 1,500
HDE Supplements—814.108 ............................................... 110 1 110 80 8,800
Notification of withdrawal of an HDE—814.116(e)(3) ......... 1 1 1 1 1
Notification of withdrawal of Institutional Review Board ap-
proval—814.124(b) ........................................................... 1 1 1 2 2
Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200
Total .............................................................................. ........................ ........................ ........................ ........................ 16,223
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeping recordkeeping
HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent
Notification of emergency use—814.124(a) ........................ 22 1 22 1 22
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in tables There have been no program changes DEPARTMENT OF HEALTH AND
1, 2, and 3 of this document are an and the estimated Average Burden per HUMAN SERVICES
average based on data for the previous Response has not changed for any of the
3 years, i.e., fiscal years 2014 through information collections since the last Food and Drug Administration
2016. The number of annual reports OMB approval.
submitted under § 814.126(b)(1) in table [Docket No. FDA–2017–N–0001]
Dated: October 11, 2017.
1 reflects 35 respondents with approved
HUD applications. Under Anna K. Abram, Request for Nominations for
ethrower on DSK3G9T082PROD with NOTICES
§ 814.126(b)(2) in table 2, the estimated Deputy Commissioner for Policy, Planning, Individuals and Consumer
number of recordkeepers is 247. Legislation, and Analysis. Organizations for Advisory
The number of respondents has been [FR Doc. 2017–22320 Filed 10–13–17; 8:45 am]
Committees
adjusted to reflect updated respondent BILLING CODE 4164–01–P AGENCY: Food and Drug Administration,
data. This has resulted in an overall HHS.
decrease of 2,971 hours to the total
ACTION: Notice.
estimated annual reporting burden.
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permit evaluation of possible sources of ADDRESSES: Written comments should different hospitals and training
conflicts of interest. Members will be be submitted to Malena Crawford, programs. Additionally, clinical
invited to serve for terms up to 4 years. Public Health Analyst, HRSA, by email outcomes alone may not be appropriate
FDA will review all nominations (MCrawford@hrsa.gov) or by fax (301– measures for establishing a GME quality
received within the specified 443–0162). improvement initiative. HRSA would
timeframes and prepare a ballot FOR FURTHER INFORMATION CONTACT: like to begin to develop approaches to
containing the names of qualified Malena Crawford, Public Health measure and assess the quality of GME
nominees. Names not selected will Analyst, HRSA, 5600 Fishers Lane, programs using existing data sources
remain on a list of eligible nominees Rockville, MD, 20852, (301) 443–7334. initially and then develop new and
and be reviewed periodically by FDA to SUPPLEMENTARY INFORMATION: The improved data sources as we learn
determine continued interest. Upon CHGME Program supports graduate which are most informative and useful.
selecting qualified nominees for the medical education (GME) in Quality Bonus Payment in FY 2019—
ballot, FDA will provide those freestanding children’s hospitals. The Proposal for Public Comment
consumer organizations that are program supports the training of
participating in the selection process HRSA is proposing a multi-step
primary care pediatricians and pediatric implementation in recognition of the
with the opportunity to vote on the medical and surgical subspecialists. The
listed nominees. Only organizations changing landscape and the need for
CHGME Support Reauthorization Act of additional data. For FY 2019, HRSA
vote in the selection process. Persons 2013 makes up to 25 percent of the total
who nominate themselves to serve as proposes a quality bonus system that
amount appropriated annually in excess will initially recognize high-level
voting or nonvoting consumer of $245 million, but not to exceed
representatives will not participate in engagement of CHGME hospitals in state
$7,000,000, available to provide and regional health care transformation,
the selection process. payments to newly qualified hospitals,
This notice is issued under the as well as engagement of resident
as defined in section 340E(h) of the trainees in these activities. HRSA is
Federal Advisory Committee Act (5 Public Health Service Act. The statute
U.S.C. app. 2) and 21 CFR part 14, seeking public comment on the
additionally states that the Secretary timeline, eligibility, standards,
relating to advisory committees. may establish a quality bonus system for documentation, and payment structure
Dated: October 11, 2017. CHGME hospitals using any remaining as described below. HRSA is also
Anna K. Abram, funds after payments are made to newly proposing areas for comment for FY
Deputy Commissioner for Policy, Planning, qualified hospitals. In FY 2017, 2020 and beyond.
Legislation, and Analysis. Congress appropriated $300 million to Timeline: HRSA anticipates
[FR Doc. 2017–22344 Filed 10–13–17; 8:45 am] the CHGME Program. Of this, implementing the proposed CHGME
BILLING CODE 4164–01–P approximately $4 million in payments Quality Bonus System standards in FY
were made to newly qualified hospitals. 2019 payments (project period October
If funding levels and mechanisms 1, 2018, through September 30, 2019).
DEPARTMENT OF HEALTH AND remain constant, it is estimated that CHGME Hospital Eligibility: HRSA
HUMAN SERVICES approximately $3 million may be proposes to include all eligible CHGME
available annually for the CHGME hospitals, including those newly
Health Resources and Services Quality Bonus System. If the total qualified, as eligible entities for the
Administration amount available for the CHGME CHGME Quality Bonus System.
Quality Bonus System in a fiscal year is Quality Bonus System Standards: The
Proposed Standards for the Children’s
less than $2 million, HRSA does not proposed standards are: (1)
Hospitals Graduate Medical Education
plan to implement the CHGME Quality Demonstration of engagement in state-
Payment Program’s Quality Bonus
Bonus System in that year to minimize or regional-level initiatives by a
System
administrative burden on the hospitals. children’s hospital to transform
AGENCY: Health Resources and Services In this case, the funds would be pediatric health care to improve access,
Administration (HRSA), Department of disbursed to all eligible hospitals quality, and cost effectiveness of health
Health and Human Services. (including those newly qualified) care; and (2) demonstration of resident
ACTION: Request for public comment. according to the CHGME formula trainee engagement in these activities.
payment methodology. HRSA has identified several
SUMMARY: This notice seeks public HRSA understands the complexities initiatives involving CHGME hospitals
comment on establishing a quality involved in designing a GME quality that require a significant level of
bonus system for the Children’s improvement initiative. The CHGME engagement. These include federally
Hospitals Graduate Medical Education Quality Bonus System would be the first funded efforts such as: Participation in
(CHGME) Payment Program. The of its kind for any federal GME payment a state Medicaid initiative to improve
CHGME Support Reauthorization Act of program and responds to changes access, quality, and cost effectiveness of
2013 states that the Secretary may occurring in the larger health care arena. pediatric health care (e.g., a Centers for
establish a quality bonus system, For example, the Accreditation Council Medicare & Medicaid Services State
whereby the Secretary distributes bonus for GME, one of the prevailing GME Innovation Model Award or other
payments to hospitals participating in accrediting bodies, recently Health Care Innovation Award with a
the program that meet standards implemented new GME program state or regional impact); participation
specified by the Secretary. The goal of requirements around patient safety and in the HRSA Maternal and Child Health
ethrower on DSK3G9T082PROD with NOTICES
this notice is to seek comment to assist quality improvement. Many GME Bureau’s Health Care Delivery System
HRSA in the development of the programs and stakeholders are working Innovations for Children with Medical
standards, payment structure, and towards establishing GME quality Complexity Collaborative Improvement
outcome measures for the CHGME related outcome metrics, but currently and Innovation Network (CoIIN); or,
Quality Bonus System. no widely accepted metrics exist that participation in HRSA’s Federal Office
DATES: Submit written comments no have the ability to distinguish between of Rural Health Policy Rural Health
later than December 15, 2017. the quality of training provided at Network Development Grant Program.
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Document Created: 2017-10-14 01:42:08
Document Modified: 2017-10-14 01:42:08
| 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 | Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a | |
| Contact | For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301-796-8220 email: [email protected] | |
| FR Citation | 82 FR 48098 |
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