83_FR_63107 83 FR 62873 - Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children

83 FR 62873 - Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 234 (December 6, 2018)

Page Range62873-62874
FR Document2018-26518

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates to fill up to five positions on the Committee.

Federal Register, Volume 83 Issue 234 (Thursday, December 6, 2018) 
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62873-62874]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26518]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Solicitation of Nominations for Membership To Serve on the 
Advisory Committee on Heritable Disorders in Newborns and Children

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Request for nominations.

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SUMMARY: HRSA is seeking nominations of qualified candidates to be 
considered for appointment as members of the Advisory Committee on 
Heritable

[[Page 62874]]

Disorders in Newborns and Children (Committee). The Committee provides 
advice, recommendations, and technical information about aspects of 
heritable disorders and newborn and childhood screening to the 
Secretary of HHS (Secretary). HRSA is seeking nominations of qualified 
candidates to fill up to five positions on the Committee.

DATES: Written nominations for membership on the Committee must be 
received on or before January 4, 2019.

ADDRESSES: Nomination packages must be submitted electronically as 
email attachments to Andrea Matthews, Genetic Services Branch, Maternal 
and Child Health Bureau, HRSA, at [email protected].

FOR FURTHER INFORMATION CONTACT: Andrea Matthews, MCHB, HRSA 5600 
Fishers Lane, Room 18-N-34D , Rockville, MD 20857; 301-945-3062; or 
[email protected]. A copy of the Committee charter and list of the 
current membership may be obtained by accessing the Committee website 
at https://www.hrsa.gov/advisory-committees/heritable-disorders/about/index.html.

SUPPLEMENTARY INFORMATION: The Committee was established in 2003 to 
advise the Secretary regarding newborn screening tests, technologies, 
policies, guidelines, and programs for effectively reducing morbidity 
and mortality in newborns and children having, or at risk for, 
heritable disorders. In addition, the Committee provides advice and 
recommendations to the Secretary concerning the grants and projects 
authorized under section 1109 of the PHS Act and technical information 
to develop policies and priorities for grants, including those that 
will enhance the ability of the state and local health agencies to 
provide for newborn and child screening, counseling, and health care 
services for newborns and children having, or at risk for, heritable 
disorders. The Committee meets four times each calendar year, or at the 
discretion of the Designated Federal Officer in consultation with the 
Chair.
    The Committee reviews and reports regularly on newborn and 
childhood screening practices for heritable disorders, recommends 
improvements in the national newborn and childhood heritable screening 
programs, and recommends conditions for inclusion in the Recommended 
Uniform Screening Panel (RUSP). The Committee's recommendations 
regarding additional conditions/inherited disorders for screening that 
have been adopted by the Secretary are included in the RUSP and 
constitute part of the comprehensive guidelines supported by HRSA 
pursuant to section 2713 of the PHS Act, codified at 42 U.S.C. 300gg-
13. Under this provision, non-grandfathered health plans and group and 
individual health insurance issuers are required to cover screenings 
included in the HRSA-supported comprehensive guidelines without 
charging a co-payment, co-insurance, or deductible for plan years 
(i.e., in the individual market, policy years) beginning on or after 
the date that is 1 year from the Secretary's adoption of the condition 
for screening.
    Nominations: HRSA is requesting nominations for voting members to 
serve on the Committee to fill one position in 2019 and up to four 
positions in 2020. The Secretary appoints Committee members with the 
expertise needed to fulfill the duties of the Advisory Committee. The 
membership requirements are set forth at 42 U.S.C. 300b-10(c)(2). 
Nominees sought are medical, technical, or scientific professionals 
with special expertise in the field of heritable disorders or in 
providing screening, counseling, testing, or specialty services for 
newborns and children with, or at risk for having, heritable disorders; 
individuals who have expertise in ethics (e.g., bioethics) and 
infectious diseases and who have worked and published material in the 
area of newborn screening; members of the public having special 
expertise about, or concern with, heritable disorders; and/or 
representatives from such federal agencies, public health 
constituencies, and medical professional societies. Interested 
applicants may self-nominate or be nominated by another individual or 
organization. Nominees must reside in the United States and cannot be 
funded for international travel.
    Individuals selected for appointment to the Committee will be 
invited to serve for up to 4 years. Members who are not federal 
officers or permanent federal employees are appointed as special 
government employees and receive a stipend and reimbursement for per 
diem and travel expenses incurred for attending Committee meetings and/
or conducting other business on behalf of the Committee, as authorized 
by 5 U.S.C. 5703 of the FACA for persons employed intermittently in 
government service. Members who are already officers or employees of 
the United States Government shall not receive additional compensation 
for service on the Committee, but receive per diem and travel expenses 
incurred for attending Committee meetings and/or conducting other 
business on behalf of the Committee.
    The following information must be included in the package of 
materials submitted for each individual being nominated for 
consideration: (1) A statement that includes the name and affiliation 
of the nominee and a clear statement regarding the basis for the 
nomination, including the area(s) of expertise that may support 
eligibility of a nominee for service on the Committee, as described 
above; (2) confirmation the nominee is willing to serve as a member of 
the Committee; (3) the nominee's contact information (please include 
home address, work address, daytime telephone number, and an email 
address); and (4) a current copy of the nominee's curriculum vitae. 
Nomination packages may be submitted directly by the individual being 
nominated or by the person/organization recommending the candidate.
    HHS will endeavor to ensure that the membership of the Committee is 
fairly balanced in terms of points of view represented and that 
individuals from a broad representation of geographic areas, gender, 
ethnic and minority groups, as well as individuals with disabilities, 
are considered for membership. Appointments shall be made without 
discrimination on the basis of age, ethnicity, gender, sexual 
orientation, and cultural, religious, or socioeconomic status.
    Individuals who are selected to be considered for appointment will 
be required to provide detailed information regarding their financial 
holdings, consultancies, and research grants or contracts. Disclosure 
of this information is required in order for HRSA to determine if the 
selected candidate is involved in any activity that may pose a 
potential conflict with the official duties to be performed as a member 
of the Committee and to identify any required remedial action needed to 
address the potential conflict.

    Authority: Section 1111 of the Public Health Service (PHS) Act, 
as amended by the Newborn Screening Saves Lives Reauthorization Act 
of 2014 (42 U.S.C. 300b-10). The Committee is governed by the 
Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), 
and 41 CFR part 102-3, which set forth standards for the formation 
and use of advisory committees.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-26518 Filed 12-5-18; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices 62873 Establishments and Transfusion one self-addressed adhesive label to practices regulation (21 CFR 10.115). Services to Enhance the Safety and assist the office in processing your The draft guidance, when finalized, will Availability of Platelets for Transfusion; requests. The draft guidance may also be represent the current thinking of FDA Draft Guidance for Industry.’’ Received obtained by mail by calling CBER at 1– on bacterial risk control strategies for comments will be placed in the docket 800–835–4709 or 240–402–8010. See blood collection establishments and and, except for those submitted as the SUPPLEMENTARY INFORMATION section transfusion services to enhance the ‘‘Confidential Submissions,’’ publicly for electronic access to the draft safety and availability of platelets for viewable at https://www.regulations.gov guidance document. transfusion. It does not establish any or at the Dockets Management Staff FOR FURTHER INFORMATION CONTACT: rights for any person and is not binding between 9 a.m. and 4 p.m., Monday Jonathan McKnight, Center for Biologics on FDA or the public. You can use an through Friday. Evaluation and Research, Food and alternative approach if it satisfies the • Confidential Submissions—To Drug Administration, Center for requirements of the applicable statutes submit a comment with confidential Biologics Evaluation and Research, and regulations. This guidance is not information that you do not wish to be Food and Drug Administration, 10903 subject to Executive Order 12866. made publicly available, submit your New Hampshire Ave., Bldg. 71, Rm. comments only as a written/paper II. Paperwork Reduction Act of 1995 7301, Silver Spring, MD 20993–0002, submission. You should submit two 240–402–7911. This draft guidance refers to copies total. One copy will include the previously approved collections of SUPPLEMENTARY INFORMATION: information you claim to be confidential information found in FDA regulations. with a heading or cover note that states I. Background These collections of information are ‘‘THIS DOCUMENT CONTAINS subject to review by the Office of FDA is announcing the availability of CONFIDENTIAL INFORMATION.’’ The Management and Budget (OMB) under a draft document entitled ‘‘Bacterial Agency will review this copy, including the Paperwork Reduction Act of 1995 Risk Control Strategies for Blood the claimed confidential information, in (44 U.S.C. 3501–3520). The collections Collection Establishments and its consideration of comments. The of information in 21 CFR part 601 have second copy, which will have the Transfusion Services to Enhance the Safety and Availability of Platelets for been approved under OMB control claimed confidential information number 0910–0338; the collections of redacted/blacked out, will be available Transfusion; Draft Guidance for Industry.’’ The draft guidance provides information in 21 CFR part 606 have for public viewing and posted on been approved under OMB control https://www.regulations.gov. Submit blood collection establishments and transfusion services with number 0910–0116; and the collections both copies to the Dockets Management of information in 21 CFR part 607 have Staff. If you do not wish your name and recommendations to control the risk of bacterial contamination of room been approved under OMB control contact information to be made publicly number 0910–0052. available, you can provide this temperature stored platelets intended information on the cover sheet and not for transfusion. The draft guidance III. Electronic Access in the body of your comments and you provides recommendations for all Persons with access to the internet must identify this information as platelet products, including platelets may obtain the draft guidance at either ‘‘confidential.’’ Any information marked manufactured by automated methods https://www.fda.gov/Biologics as ‘‘confidential’’ will not be disclosed (apheresis platelets), WBD platelets, BloodVaccines/GuidanceCompliance except in accordance with 21 CFR 10.20 pooled platelets (pre-storage and post- RegulatoryInformation/Guidances/ and other applicable disclosure law. For storage) and platelets stored in additive default.htm or https:// more information about FDA’s posting solutions. Additionally, this guidance www.regulations.gov. of comments to public dockets, see 80 provides licensed blood establishments with recommendations on how to report Dated: November 29, 2018. FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ implementation of manufacturing and Leslie Kux, fdsys/pkg/FR-2015-09-18/pdf/2015- labeling changes under 21 CFR 601.12. Associate Commissioner for Policy. 23389.pdf. The draft guidance replaces the draft [FR Doc. 2018–26477 Filed 12–4–18; 8:45 am] Docket: For access to the docket to guidance of the same title dated March BILLING CODE 4164–01–P read background documents or the 2016 (81 FR 13798; March 15, 2016). electronic and written/paper comments Most recently, FDA convened a Blood received, go to https:// Products Advisory Committee (BPAC) DEPARTMENT OF HEALTH AND www.regulations.gov and insert the meeting in July 2018 to discuss bacterial HUMAN SERVICES docket number, found in brackets in the contamination of platelets and strategies heading of this document, into the to control the risk. At this meeting, Health Resources and Services ‘‘Search’’ box and follow the prompts BPAC considered the scientific evidence Administration and/or go to the Dockets Management and operational considerations of all available strategies to control the risk of Solicitation of Nominations for Staff, 5630 Fishers Lane, Rm. 1061, bacterial contamination of platelets with Membership To Serve on the Advisory Rockville, MD 20852. 5-day and 7-day dating, including Committee on Heritable Disorders in You may submit comments on any bacterial testing strategies using culture- Newborns and Children guidance at any time (see 21 CFR 10.115(g)(5)). based devices, rapid bacterial detection AGENCY: Health Resources and Services Submit written requests for single devices, and the implementation of khammond on DSK30JT082PROD with NOTICES Administration (HRSA), Department of copies of the draft guidance to the Office pathogen reduction technology. The Health and Human Services (HHS). of Communication, Outreach and data presented and BPAC’s discussion ACTION: Request for nominations. Development, Center for Biologics at the July 2018 meeting provided the Evaluation and Research (CBER), Food foundation for the recommendations in SUMMARY: HRSA is seeking nominations and Drug Administration, 10903 New this guidance. of qualified candidates to be considered Hampshire Ave., Bldg. 71, Rm. 3128, This draft guidance is being issued for appointment as members of the Silver Spring, MD 20993–0002. Send consistent with FDA’s good guidance Advisory Committee on Heritable VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1

62874 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices Disorders in Newborns and Children constitute part of the comprehensive The following information must be (Committee). The Committee provides guidelines supported by HRSA pursuant included in the package of materials advice, recommendations, and technical to section 2713 of the PHS Act, codified submitted for each individual being information about aspects of heritable at 42 U.S.C. 300gg–13. Under this nominated for consideration: (1) A disorders and newborn and childhood provision, non-grandfathered health statement that includes the name and screening to the Secretary of HHS plans and group and individual health affiliation of the nominee and a clear (Secretary). HRSA is seeking insurance issuers are required to cover statement regarding the basis for the nominations of qualified candidates to screenings included in the HRSA- nomination, including the area(s) of fill up to five positions on the supported comprehensive guidelines expertise that may support eligibility of Committee. without charging a co-payment, co- a nominee for service on the Committee, insurance, or deductible for plan years DATES: Written nominations for as described above; (2) confirmation the (i.e., in the individual market, policy membership on the Committee must be nominee is willing to serve as a member years) beginning on or after the date that received on or before January 4, 2019. of the Committee; (3) the nominee’s is 1 year from the Secretary’s adoption ADDRESSES: Nomination packages must of the condition for screening. contact information (please include be submitted electronically as email Nominations: HRSA is requesting home address, work address, daytime attachments to Andrea Matthews, nominations for voting members to telephone number, and an email Genetic Services Branch, Maternal and serve on the Committee to fill one address); and (4) a current copy of the Child Health Bureau, HRSA, at position in 2019 and up to four nominee’s curriculum vitae. AMatthews@hrsa.gov. positions in 2020. The Secretary Nomination packages may be submitted FOR FURTHER INFORMATION CONTACT: appoints Committee members with the directly by the individual being Andrea Matthews, MCHB, HRSA 5600 expertise needed to fulfill the duties of nominated or by the person/ Fishers Lane, Room 18–N–34D , the Advisory Committee. The organization recommending the Rockville, MD 20857; 301–945–3062; or membership requirements are set forth candidate. AMatthews@hrsa.gov. A copy of the at 42 U.S.C. 300b–10(c)(2). Nominees HHS will endeavor to ensure that the Committee charter and list of the sought are medical, technical, or scientific professionals with special membership of the Committee is fairly current membership may be obtained by expertise in the field of heritable balanced in terms of points of view accessing the Committee website at disorders or in providing screening, represented and that individuals from a https://www.hrsa.gov/advisory- committees/heritable-disorders/about/ counseling, testing, or specialty services broad representation of geographic index.html. for newborns and children with, or at areas, gender, ethnic and minority risk for having, heritable disorders; groups, as well as individuals with SUPPLEMENTARY INFORMATION: The individuals who have expertise in ethics disabilities, are considered for Committee was established in 2003 to (e.g., bioethics) and infectious diseases membership. Appointments shall be advise the Secretary regarding newborn and who have worked and published made without discrimination on the screening tests, technologies, policies, material in the area of newborn basis of age, ethnicity, gender, sexual guidelines, and programs for effectively screening; members of the public having orientation, and cultural, religious, or reducing morbidity and mortality in special expertise about, or concern with, socioeconomic status. newborns and children having, or at risk heritable disorders; and/or for, heritable disorders. In addition, the Individuals who are selected to be representatives from such federal Committee provides advice and considered for appointment will be agencies, public health constituencies, recommendations to the Secretary and medical professional societies. required to provide detailed information concerning the grants and projects Interested applicants may self-nominate regarding their financial holdings, authorized under section 1109 of the or be nominated by another individual consultancies, and research grants or PHS Act and technical information to or organization. Nominees must reside contracts. Disclosure of this information develop policies and priorities for in the United States and cannot be is required in order for HRSA to grants, including those that will funded for international travel. determine if the selected candidate is enhance the ability of the state and local Individuals selected for appointment involved in any activity that may pose health agencies to provide for newborn to the Committee will be invited to a potential conflict with the official and child screening, counseling, and serve for up to 4 years. Members who duties to be performed as a member of health care services for newborns and are not federal officers or permanent the Committee and to identify any children having, or at risk for, heritable federal employees are appointed as required remedial action needed to disorders. The Committee meets four special government employees and address the potential conflict. times each calendar year, or at the receive a stipend and reimbursement for discretion of the Designated Federal Authority: Section 1111 of the Public per diem and travel expenses incurred Officer in consultation with the Chair. Health Service (PHS) Act, as amended by the for attending Committee meetings and/ The Committee reviews and reports Newborn Screening Saves Lives or conducting other business on behalf regularly on newborn and childhood Reauthorization Act of 2014 (42 U.S.C. 300b- of the Committee, as authorized by 5 screening practices for heritable 10). The Committee is governed by the U.S.C. 5703 of the FACA for persons disorders, recommends improvements Federal Advisory Committee Act (FACA), as employed intermittently in government amended (5 U.S.C. App.), and 41 CFR part in the national newborn and childhood service. Members who are already 102–3, which set forth standards for the heritable screening programs, and officers or employees of the United khammond on DSK30JT082PROD with NOTICES formation and use of advisory committees. recommends conditions for inclusion in States Government shall not receive the Recommended Uniform Screening additional compensation for service on Amy McNulty, Panel (RUSP). The Committee’s the Committee, but receive per diem Acting Director, Division of the Executive recommendations regarding additional and travel expenses incurred for Secretariat. conditions/inherited disorders for attending Committee meetings and/or [FR Doc. 2018–26518 Filed 12–5–18; 8:45 am] screening that have been adopted by the conducting other business on behalf of BILLING CODE 4165–15–P Secretary are included in the RUSP and the Committee. VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1


Document Created: 2018-12-05 02:35:40
Document Modified: 2018-12-05 02:35:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for nominations.
DatesWritten nominations for membership on the Committee must be received on or before January 4, 2019.
ContactAndrea Matthews, MCHB, HRSA 5600 Fishers Lane, Room 18-N-34D , Rockville, MD 20857; 301-945-3062; or [email protected] A copy of the Committee charter and list of the current membership may be obtained by accessing the Committee website at https://www.hrsa.gov/advisory-committees/heritable-disorders/about/ index.html.
FR Citation83 FR 62873 
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