48098 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

sections 514 and 515 of the FD&C Act 

(21 U.S.C. 360d and 360e) provided that 

the device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risks and benefits 

of currently available devices or 

alternative forms of treatment. 

Respondents may submit a 

humanitarian device exemption (HDE) 

application seeking exemption from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act as 

authorized by section 520(m)(2). The 

information collected will assist FDA in 

making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

whether to exempt an HUD from the 

effectiveness requirements under 

sections 514 and 515 of the FD&C Act, 

provided that the device meets 

requirements set forth under section 

520(m) of the FD&C Act; and (3) 

whether to grant marketing approval(s) 

for the HUD. Failure to collect this 

information would prevent FDA from 

making a determination on the factors 

listed previously in this document. 

Further, the collected information 

would also enable FDA to determine 

whether the holder of an HUD is in 

compliance with the HUD provisions 

under section 520(m) of the FD&C Act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

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 approval—814.124(b) ........................................................... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................... 35 1 35 120 4,200 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,223 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeping 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification of emergency use—814.124(a) ........................ 22 1 22 1 22 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents in tables 

1, 2, and 3 of this document are an 

average based on data for the previous 

3 years, i.e., fiscal years 2014 through 

2016. The number of annual reports 

submitted under § 814.126(b)(1) in table 

1 reflects 35 respondents with approved 

HUD applications. Under 

§ 814.126(b)(2) in table 2, the estimated 

number of recordkeepers is 247. 

The number of respondents has been 

adjusted to reflect updated respondent 

data. This has resulted in an overall 

decrease of 2,971 hours to the total 

estimated annual reporting burden. 

There have been no program changes 

and the estimated Average Burden per 

Response has not changed for any of the 

information collections since the last 

OMB approval. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22320 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

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. 


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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 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 ACOMSSubmissions@

fda.hhs.gov; 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: kimberly.hamilton@

fda.hhs.gov. 

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 Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002, phone: 301–796–2721, email: 

Lauren.Tesh@fda.hhs.gov.

Antimicrobial Advisory Committee. 

Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993–0002, phone: 301–796–6875, email: 

Patricio.Garcio@fda.hhs.gov.

Clinical Chemistry and Clinical 

Toxicology Devices Panel. 

Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993–0002, phone: 301–796–6683, email: 

Evella.Washington@fda.hhs.gov.

Ear, Nose and Throat Devices 

Panel, Immunology Devices 

Panel. 

Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993–0002, phone: 301–796–5433, email: 

Pamela.Scott@fda.hhs.gov.

Medical Devices Dispute Resolution. 

Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–0002, phone: 301–796–0400, email: 

Aden.Asefa@fda.hhs.gov.

Neurological Devices Panel. 

LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993–0002, phone: 301–796–2855, email: 

LaToya.Bonner@fda.hhs.gov.

Endocrinologic and Metabolic 

Drugs Advisory Committee. 

Karen Strambler, Center for Food Safety and Nutrition, Food and Drug Administration, FDA College Park, 

CPK1, Rm. 1C008, College Park, MD 20740, phone: 240–402–2589, email: Karen.Strambler@

fda.hhs.gov.

Food Advisory Committee. 

Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, phone: 301–796–0889, email: 

Cindy.Chee@fda.hhs.gov.

Gastrointestinal Drugs Advisory 

Committee, Pulmonary-Allergy 

Drugs Advisory Committee. 

Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–4043, email: Jennifer.Shepherd@fda.hhs.gov.

Medical Imaging Advisory Committee. 

Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, phone: 301–796–2894, email: 

MoonHee.Choi@fda.hhs.gov.

Non-Prescription Drugs Advisory 

Committee, Peripheral & Central 

Nervous Systems Advisory Committee. 

Marieann Brill, Office of the Commissioner, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993–0002, phone: 

240–402–3838, email: Mariann.Brill@fda.hhs.gov.

Pediatrics Advisory Committee. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting and/ 

or nonvoting consumer representatives 

for the vacancies listed in table 2. 


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48100 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

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—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.1—Voting .............................. November 30, 2017. 

Clinical Chemistry and Clinical Toxicology 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.1—Nonvoting ........................ Immediately. 

Ear, Nose and Throat Devices Panel—Otologists, neurologists, and audiologists ............. 1—Nonvoting ........................ Immediately. 

Immunology Devices—Persons with experience in medical, surgical, or clinical oncology, 

internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.

1—Nonvoting ........................ Immediately. 

Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific, clinical, 

analytical, or mediation skills.

1—Nonvoting ........................ Immediately. 

Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional 

neuroradiologists, psychiatrists, and biostatisticians.

1—Nonvoting ........................ Immediately. 

Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields 

of endocrinology, metabolism, epidemiology or statistics, and related specialties.

1—Voting .............................. Immediately. 

Food Advisory Committee—Knowledgeable in 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.

1—Voting .............................. Immediately. 

Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver 

function, motility, esophagitis, and statistics.

1—Voting .............................. Immediately. 

Pulmonary-Allergy Drugs Advisory Committee—Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics.1—Voting .............................. Immediately. 

Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, 

radiology, epidemiology, statistics, and related specialties.

1—Voting .............................. Immediately. 

Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal 

medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties.

1—Voting .............................. Immediately. 

Peripheral and Central Nervous System Drugs Advisory Committee—Knowledgeable in 

the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.

1—Voting .............................. Immediately. 

Pediatrics Advisory Committee—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.

1—Voting .............................. Immediately. 

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 


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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 re ́sume ́. 

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 re ́sume ́ 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 selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 


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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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Proposed Standards for the Children’s 

Hospitals Graduate Medical Education 

Payment Program’s Quality Bonus 

System 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Request for public comment. 

SUMMARY: This notice seeks public 

comment on establishing a quality 

bonus system for the Children’s 

Hospitals Graduate Medical Education 

(CHGME) Payment Program. The 

CHGME Support Reauthorization Act of 

2013 states that the Secretary may 

establish a quality bonus system, 

whereby the Secretary distributes bonus 

payments to hospitals participating in 

the program that meet standards 

specified by the Secretary. The goal of 

this notice is to seek comment to assist 

HRSA in the development of the 

standards, payment structure, and 

outcome measures for the CHGME 

Quality Bonus System. 

DATES: Submit written comments no 

later than December 15, 2017. 

ADDRESSES: Written comments should 

be submitted to Malena Crawford, 

Public Health Analyst, HRSA, by email 

(MCrawford@hrsa.gov) or by fax (301– 

443–0162). 

FOR FURTHER INFORMATION CONTACT: 

Malena Crawford, Public Health 

Analyst, HRSA, 5600 Fishers Lane, 

Rockville, MD, 20852, (301) 443–7334. 

SUPPLEMENTARY INFORMATION: The 

CHGME Program supports graduate 

medical education (GME) in 

freestanding children’s hospitals. The 

program supports the training of 

primary care pediatricians and pediatric 

medical and surgical subspecialists. The 

CHGME Support Reauthorization Act of 

2013 makes up to 25 percent of the total 

amount appropriated annually in excess 

of $245 million, but not to exceed 

$7,000,000, available to provide 

payments to newly qualified hospitals, 

as defined in section 340E(h) of the 

Public Health Service Act. The statute 

additionally states that the Secretary 

may establish a quality bonus system for 

CHGME hospitals using any remaining 

funds after payments are made to newly 

qualified hospitals. In FY 2017, 

Congress appropriated $300 million to 

the CHGME Program. Of this, 

approximately $4 million in payments 

were made to newly qualified hospitals. 

If funding levels and mechanisms 

remain constant, it is estimated that 

approximately $3 million may be 

available annually for the CHGME 

Quality Bonus System. If the total 

amount available for the CHGME 

Quality Bonus System in a fiscal year is 

less than $2 million, HRSA does not 

plan to implement the CHGME Quality 

Bonus System in that year to minimize 

administrative burden on the hospitals. 

In this case, the funds would be 

disbursed to all eligible hospitals 

(including those newly qualified) 

according to the CHGME formula 

payment methodology. 

HRSA understands the complexities 

involved in designing a GME quality 

improvement initiative. The CHGME 

Quality Bonus System would be the first 

of its kind for any federal GME payment 

program and responds to changes 

occurring in the larger health care arena. 

For example, the Accreditation Council 

for GME, one of the prevailing GME 

accrediting bodies, recently 

implemented new GME program 

requirements around patient safety and 

quality improvement. Many GME 

programs and stakeholders are working 

towards establishing GME quality 

related outcome metrics, but currently 

no widely accepted metrics exist that 

have the ability to distinguish between 

the quality of training provided at 

different hospitals and training 

programs. Additionally, clinical 

outcomes alone may not be appropriate 

measures for establishing a GME quality 

improvement initiative. HRSA would 

like to begin to develop approaches to 

measure and assess the quality of GME 

programs using existing data sources 

initially and then develop new and 

improved data sources as we learn 

which are most informative and useful. 

Quality Bonus Payment in FY 2019— 

Proposal for Public Comment 

HRSA is proposing a multi-step 

implementation in recognition of the 

changing landscape and the need for 

additional data. For FY 2019, HRSA 

proposes a quality bonus system that 

will initially recognize high-level 

engagement of CHGME hospitals in state 

and regional health care transformation, 

as well as engagement of resident 

trainees in these activities. HRSA is 

seeking public comment on the 

timeline, eligibility, standards, 

documentation, and payment structure 

as described below. HRSA is also 

proposing areas for comment for FY 

2020 and beyond. 

Timeline: HRSA anticipates 

implementing the proposed CHGME 

Quality Bonus System standards in FY 

2019 payments (project period October 

1, 2018, through September 30, 2019). 

CHGME Hospital Eligibility: HRSA 

proposes to include all eligible CHGME 

hospitals, including those newly 

qualified, as eligible entities for the 

CHGME Quality Bonus System. 

Quality Bonus System Standards: The 

proposed standards are: (1) 

Demonstration of engagement in stateor regional-level initiatives by a 

children’s hospital to transform 

pediatric health care to improve access, 

quality, and cost effectiveness of health 

care; and (2) demonstration of resident 

trainee engagement in these activities. 

HRSA has identified several 

initiatives involving CHGME hospitals 

that require a significant level of 

engagement. These include federally 

funded efforts such as: Participation in 

a state Medicaid initiative to improve 

access, quality, and cost effectiveness of 

pediatric health care (e.g., a Centers for 

Medicare & Medicaid Services State 

Innovation Model Award or other 

Health Care Innovation Award with a 

state or regional impact); participation 

in the HRSA Maternal and Child Health 

Bureau’s Health Care Delivery System 

Innovations for Children with Medical 

Complexity Collaborative Improvement 

and Innovation Network (CoIIN); or, 

participation in HRSA’s Federal Office 

of Rural Health Policy Rural Health 

Network Development Grant Program. 


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