Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42659 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.676] 

Announcement of Intent To Solicit and 

Issue One OPDIV-Initiated Supplement 

to Lutheran Immigration and Refugee 

Service, Inc. Under the Standing 

Announcement for Residential 

(Shelter) Services for Unaccompanied 

Children, HHS–2017–ACF–ORR–ZU– 

1132 

AGENCY: Unaccompanied Alien 

Children (UAC) Program, Office of 

Refugee Resettlement (ORR), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS). 

ACTION: Notice of solicitation and intent 

to issue of one OPDIV-Initiated 

Supplement to Lutheran Immigration 

and Refugee Service, Inc., Baltimore, 

MD under the UAC Program. 

SUMMARY: ACF, ORR announces the 

solicitation and intent to issue one 

OPDIV-Initiated Supplement to 

Lutheran Immigration and Refugee 

Service, Inc., Baltimore, MD in an 

amount not to exceed $1,000,000. 

ORR has been identifying additional 

capacity for fingerprinting services for 

an expected increase in the number of 

sponsors (parents, guardians, or family 

friends to whom the UAC will be 

released) who will need to be 

fingerprinted. Planning for increased 

fingerprinting capacity is a prudent step 

to ensure that ORR is able to meet its 

responsibility, by law, to ensure that the 

sponsor has not engaged in any activity 

that would indicate a potential risk to 

the UAC. 

DATES: Supplemental award funds will 

support activities for up to eight months 

after award. 

FOR FURTHER INFORMATION CONTACT: 

Jallyn Sualog, Director, Division of 

Unaccompanied Children Operations, 

Office of Refugee Resettlement, 330 C 

Street SW, Washington, DC 20201. 

Telephone: 202–401–4997; email: 

jallyn.sualog@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: ORR is 

continuously monitoring its capacity to 

provide fingerprinting services to the 

sponsors of UAC referred to HHS, as 

well as the information received from 

interagency partners, to inform any 

future decisions or actions. 

ORR has specific requirements for the 

provision of services. Award recipients 

must have the infrastructure, licensing, 

experience, and appropriate level of 

trained staff to meet those requirements. 

The expansion of the existing program 

and its services through this 

supplemental award is a key strategy for 

ORR to be prepared to meet its 

responsibility to provide fingerprinting 

services to the sponsors of UAC referred 

to its care by DHS. 

ORR plans to solicit an application 

from Lutheran Immigration and Refugee 

Service, Inc., Baltimore, MD to meet the 

fingerprinting needs. If the application 

received a favorable objective review, 

ORR intends to issue a supplement in 

the amount up to $1,000,000. 

Statutory Authority: This program is 

authorized by— 

(A) Section 462 of the Homeland 

Security Act of 2002, which in March 

2003, transferred responsibility for the 

care and custody of Unaccompanied 

Alien Children from the Commissioner 

of the former Immigration and 

Naturalization Service (INS) to the 

Director of ORR of the Department of 

Health and Human Services (HHS). 

(B) The Flores Settlement Agreement, 

Case No. CV85–4544RJK (C.D. Cal. 

1996), as well as the William 

Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008 

(Pub. L. 110–457), which authorizes 

post release services under certain 

conditions to eligible children. All 

programs must comply with the Flores 

Settlement Agreement, Case No. CV85– 

4544–RJK (C.D. Cal. 1996), pertinent 

regulations and ORR policies and 

procedures. 

Elizabeth Leo, 

Grants Policy Specialist, Division of Grants 

Policy, Office of Administration. 

[FR Doc. 2018–18230 Filed 8–22–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3079] 

Request for Nominations for Voting 

Members on Public Advisory Panels or 

Committees; Device Good 

Manufacturing Practice Advisory 

Committee and the Medical Devices 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Device Good 

Manufacturing Practice Advisory 

Committee and device panels of the 

Medical Devices Advisory Committee in 

the Center for Devices and Radiological 

Health. This annual notice is also in 

accordance with the 21st Century Cures 

Act, which requires the Secretary to 

provide an annual opportunity for 

patients, representatives of patients, and 

sponsors of medical devices that may be 

specifically the subject of a review by a 

classification panel to provide 

recommendations for individuals with 

appropriate expertise to fill voting 

member positions on classification 

panels. 

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: Nominations received on or 

before October 22, 2018 will be given 

first consideration for membership on 

the Device Good Manufacturing Practice 

Advisory Committee and Panels of the 

Medical Devices Advisory Committee. 

Nominations received after October 22, 

2018 will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, contact the following 

persons listed in table 1: 


daltland on DSKBBV9HB2PROD with NOTICES
42660 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

TABLE 1—PANEL AND ADVISORY COMMITTEE CONTACTS

Primary contact person or designated federal officer Committee/panel 

Joannie Adams-White, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., 

Bldg. 66, Rm. 5519, Silver Spring, MD 20993, 301–796–5421, email: 

Joannie.Adams-White@fda.hhs.gov.

Medical Devices Dispute Resolution Panel. 

LCDR Sara Anderson, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., 

Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301–796–7047, email: 

Sara.Anderson@fda.hhs.gov.

Dental Products Panel. 

Hematology and Pathology Devices Panel. 

Orthopaedic and Rehabilitation Devices Panel. 

Radiological Devices Panel. 

Aden S. Asefa, Office of Device Evaluation, Center for Devices and Radiological 

Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, 

Rm. G642, Silver Spring, MD 20993, 301–796–0400, email: Aden.Asefa@

fda.hhs.gov.

Immunology Devices Panel. 

Microbiology Devices Panel. 

Neurological Devices Panel. 

Ophthalmic Devices Panel. 

Device Good Manufacturing Practice Advisory Committee. 

LCDR Patricio G. Garcia, Office of Device Evaluation, Center for Devices and 

Radiological Health, Food and Drug Administration,10903 New Hampshire 

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

Patricio.Garcia@fda.hhs.gov.

Clinical Chemistry and Clinical Toxicology Devices Panel. 

Gastroenterology and Urology Devices Panel. 

General and Plastic Surgery Devices Panel. 

Obstetrics and Gynecology Devices Panel. 

Evella F. Washington, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., 

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

Evella.Washington@fda.hhs.gov.

Anesthesiology and Respiratory Therapy Devices Panel. 

Circulatory System Devices Panel. 

Ear, Nose and Throat Devices Panel. 

General Hospital and Personal Use Devices Panel. 

Molecular and Clinical Genetics Devices Panel. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members for vacancies listed in table 2: 

TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED

Committee/panel expertise needed Vacancies Approximate 

date needed 

Device Good Manufacturing Practice Advisory Committee—Experts needed to provide cross-cutting scientific or clinical expertise concerning the particular issue in 

dispute. Vacancies include a representative of the interests of the general public 

and government and representatives of the interests of physicians and other 

health professionals.

1 General Public Representative ............

2 Health Professional Representatives. 

1 Government Representative ................

Immediately. 

6/1/2019. 

Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices 

Advisory Committee—Anesthesiologists, pulmonary medicine specialists, or 

other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia.

1 ..............................................................

3 ..............................................................

Immediately. 

11/30/2018. 

Circulatory System Devices Panel of the Medical Devices Advisory Committee— 

Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, 

vascular and cardiothoracic surgeons, and cardiologists with special interest in 

congestive heart failure.

3 .............................................................. Immediately. 

Clinical Chemistry and Clinical Toxicology Panel of the Medical Devices Advisory 

Committee—Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.

1 .............................................................. 2/28/2019. 

Dental Products Panel of the Medical Devices Advisory Committee—Dentists, engineers, and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy.2 .............................................................. 10/31/2018. 

Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee—Otologists, neurotologists, audiologists.3 .............................................................. 10/31/2018. 

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory 

Committee—Gastroenterologists, urologists, and nephrologists.

0 .............................................................. N/A. 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, 

wound healing, and quality of life; and biostatisticians.

1 ..............................................................

1 ..............................................................

Immediately. 

8/31/2018. 

General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee—Internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers or microbiologists/infection control 

practitioners or experts.

3 ..............................................................

3 ..............................................................

Immediately. 

12/31/2018. 


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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42661 

TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued 

Committee/panel expertise needed Vacancies Approximate 

date needed 

Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—Hematologists (benign and/or malignant hematology), 

hematopathologists (general and special hematology, coagulation and homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers.

1 .............................................................. 2/28/2019. 

Immunology Devices Panel of the Medical Devices Advisory Committee—Persons 

with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.

1 ..............................................................

2 ..............................................................

Immediately. 

2/28/19. 

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills.1 .............................................................. 9/30/2018. 

Microbiology Devices Panel of the Medical Devices Advisory Committee—Infectious disease (ID) clinicians (e.g. pulmonary disease specialists, sexually transmitted disease specialists, pediatric ID specialists, tropical diseases specialists) 

and clinical microbiologists experienced in emerging infectious diseases; clinical 

microbiology laboratory directors; molecular biologists with experience in in vitro 

diagnostic device testing; virologists; hepatologists; or clinical oncologists experienced with tumor resistance and susceptibility.

2 .............................................................. Immediately. 

Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory 

Committee—Human genetics and in the clinical management of patients with 

genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals 

with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, and clinical 

molecular genetics testing (e.g., genotyping, array comparative genomic hybridization (CGH), etc.) Individuals with experience in genetics counseling, medical 

ethics are also desired, and individuals with experience in ancillary fields of 

study will be considered.

3 ..............................................................

2 ..............................................................

Immediately. 

5/31/2019. 

Neurological Devices Panel of the Medical Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain 

management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.

1 .............................................................. Immediately. 

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee—Perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, 

electrosurgery, laser surgery, assisted reproductive technologies, contraception, 

postoperative adhesions, and cervical cancer and colposcopy; biostatisticians 

and engineers with experience in obstetrics/gynecology devices; 

urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and 

delivery nursing.

1 ..............................................................

2 ..............................................................

Immediately. 

1/31/2019. 

Ophthalmic Devices Panel of the Medical Devices Advisory Committee—Ophthalmologists specializing in cataract and refractive surgery and vitreo-retinal surgery, in addition to vision scientists, optometrists, and biostatisticians practiced 

in ophthalmic clinical trials.

2 ..............................................................

3 ..............................................................

Immediately. 

10/31/2018. 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory 

Committee—Orthopaedic surgeons (joint, spine, trauma, and pediatric); 

rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians.

2 ..............................................................

1 ..............................................................

8/31/2018. 

8/31/2019. 

Radiological Devices Panel of the Medical Devices Advisory Committee—Physicians with experience in general radiology, mammography, ultrasound, magnetic 

resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and image analysis.

3 ..............................................................

3 ..............................................................

Immediately. 

1/31/2019. 

I. General Description of the 

Committees Duties 

A. Device Good Manufacturing Practice 

Advisory Committee 

The Committee reviews regulations 

proposed for promulgation regarding 

good manufacturing practices governing 

the methods used in, and the facilities 

and controls used for, the manufacture, 

packing, storage, and installation of 

devices, and makes recommendations to 

the Commissioner of Food and Drugs 

(the Commissioner) regarding the 

feasibility and reasonableness of those 

proposed regulations. The Committee 

also advises the Commissioner on any 

petition submitted by a manufacturer for 

an exemption or variance from good 

manufacturing practice regulations that 

is referred to the committee. 

B. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in a 

number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) envisions for 

device advisory panels. With the 

exception of the Medical Devices 


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42662 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

Dispute Resolution Panel, each panel, 

according to its specialty area, performs 

the following duties: (1) Advises the 

Commissioner regarding recommended 

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 FD&C 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 

on issues relating to the design of 

clinical studies regarding the safety and 

effectiveness of marketed and 

investigational devices. 

The Dental Products Panel also 

functions at times as a dental drug 

panel. The functions of the dental drug 

panel are to evaluate and recommend 

whether various prescription drug 

products should be changed to over-thecounter status and to evaluate data and 

make recommendations concerning the 

approval of new dental drug products 

for human use. 

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. 

II. Criteria for Voting Members 

A. Device Good Manufacturing Practice 

Advisory Committee 

The Committee consists of a core of 

nine members including the Chair. 

Members and the Chair are selected by 

the Secretary of Health and Human 

Services. Persons nominated for 

membership as a health professional or 

officer or employee of any Federal, 

State, or local government should have 

knowledge of or expertise in any one or 

more of the following areas: Quality 

assurance concerning the design, 

manufacture, and use of medical 

devices. To be eligible for selection as 

a representative of the general public, 

nominees should possess appropriate 

qualifications to understand and 

contribute to the committee’s work. 

Three of the members shall be officers 

or employees of any State or local 

government or of the Federal 

Government; two shall be representative 

of the interests of the device 

manufacturing industry; two shall be 

representatives of the interests of 

physicians and other health 

professionals; and two shall be 

representatives of the interests of the 

general public. Almost all non-Federal 

members of this committee serves as 

Special Government Employees. 

Members are invited to serve for 

overlapping terms of 4 years. The 

particular needs at this time for this 

committee are listed in table 2 of this 

document. 

B. Panels of the Medical Devices 

Advisory Committee 

The Medical Devices Advisory 

Committee (MDAC) with its 18 panels 

shall consist of a maximum of 159 

standing members. Members are 

selected by the Commissioner or 

designee from among authorities in 

clinical and administrative medicine, 

engineering, biological and physical 

sciences, and other related professions. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. A maximum of 122 

members shall be standing voting 

members and 37 shall be nonvoting 

members who serve as representatives 

of consumer interests and of industry 

interests. FDA is publishing separate 

documents announcing the Request for 

Nominations Notification for NonVoting Representatives on certain 

panels of the MDAC. Persons nominated 

for membership on the panels should 

have adequately diversified experience 

appropriate to the work of the panel in 

such fields as clinical and 

administrative medicine, engineering, 

biological and physical sciences, 

statistics, and other related professions. 

The nature of specialized training and 

experience necessary to qualify the 

nominee as an expert suitable for 

appointment may include experience in 

medical practice, teaching, and/or 

research relevant to the field of activity 

of the panel. The particular needs at this 

time for each panel are listed in table 2. 

Members will be invited to serve for 

terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on one or more of the 

advisory panels or advisory committees. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete resume or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must also 

specify the advisory committee(s) for 

which the nominee is recommended. 

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 related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

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: August 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18216 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2896] 

Osteoarthritis: Structural Endpoints for 

the Development of Drugs, Devices, 

and Biological Products for Treatment; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Osteoarthritis: Structural Endpoints for 

the Development of Drugs, Devices, and 

Biological Products for Treatment.’’ The 

purpose of this draft guidance is to 

assist sponsors who are developing 

drugs, devices, or biological products to 

treat the underlying pathophysiology 

and structural progression of 

osteoarthritis (OA). This draft guidance 

does not address improvement of 

symptoms of OA, such as pain or 


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