80 FR 36825 - Advisory Committee on Heritable Disorders in Newborns and Children Request for Nominations
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 123 (June 26, 2015)
Federal Register Volume 80, Issue 123 (June 26, 2015)
| Page Range | 36825-36826 | |
| FR Document | 2015-15744 |
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)] [Notices] [Pages 36825-36826] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15744] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children Request for Nominations AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of request for nominations. ----------------------------------------------------------------------- SUMMARY: The Health Resources and Services Administration (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 Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee. Authority: Section 1111 of the Public Health Service (PHS) Act, Title XI, Sec. 1111(g)(1) (42 U.S.C. 300b-10(g)(1)), as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014. The Committee is governed by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR part 102-3 and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees. DATES: Written nominations for membership on the Committee must be received on or before July 27, 2015. ADDRESSES: Nomination packages must be submitted electronically as email attachments to Ms. Lisa M. Vasquez, Genetic Services Branch, Maternal and Child Health Bureau, Health Resources and Services Administration, [email protected]. FOR FURTHER INFORMATION CONTACT: Ms. Lisa Vasquez, Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at [email protected] or (301) 443-4948. A copy of the Committee Charter and list of the current membership can be obtained by accessing the Advisory Committee Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. SUPPLEMENTARY INFORMATION: The Committee is chartered under section 1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b-10, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2015 (Act). The Committee was established in 2003 to advise the Secretary of the U.S. Department of Health and Human Services 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 is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees. 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 the Health Resources and Services Administration. Pursuant to section 2713 of the Public Health Service Act, codified at 42 U.S.C. 300gg-13, 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 to fill three (3) positions for voting members to serve on the Committee. Nominations of potential candidates for consideration are being sought for individuals who are medical, technical, public health, 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 at risk for heritable disorders; who have expertise in ethics (i.e., 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; or members from such federal agencies, public health constituencies, and medical professional societies as determined to be necessary by the Secretary. Interested applicants may self- nominate or be nominated by another individual and/or organization. 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 any travel expenses incurred for attending Committee meetings and/or conducting other business on behalf of the Committee, as authorized by section 5 U.S.C. 5703 for persons employed intermittently in government service. Members who are 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. Nominees will be invited to serve during calendar year 2016. The following information must be included in the package of materials submitted for each individual being [[Page 36826]] nominated for consideration: (1) A statement that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes such as expertise in bioethics, evidence review, public health, laboratory, maternal and child health, or clinical expertise in heritable disorders, which qualify the nominee for service in this capacity), and that the nominee is willing to serve as a member of the Committee; (2) the nominee's name, address, and daytime telephone number and the home/or work address, telephone number, and email address; and (3) a current copy of the nominee's curriculum vitae. Nomination packages may be summited directly by the individual being nominated or by the person/organization recommending the candidate. The Department of Health and Human Services will make every effort to ensure that the membership of the Committee is fairly balanced in terms of points of view represented. Every effort is made to ensure that individuals from a broad representation of geographic areas, gender, ethnic and minority groups, as well as individuals with disabilities are given consideration 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 necessary in order 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-15744 Filed 6-25-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices 36825
FDA based the burden estimates in DATES: Written nominations for part of the comprehensive guidelines
Table 1 of this document on past membership on the Committee must be supported by the Health Resources and
experience with direct contact with the received on or before July 27, 2015. Services Administration. Pursuant to
medical device manufacturers and ADDRESSES: Nomination packages must section 2713 of the Public Health
anticipated changes in the medical be submitted electronically as email Service Act, codified at 42 U.S.C.
device manufacturing patterns for the attachments to Ms. Lisa M. Vasquez, 300gg–13, non-grandfathered health
specific devices being monitored. FDA Genetic Services Branch, Maternal and plans and group and individual health
estimates that approximately 125 Child Health Bureau, Health Resources insurance issuers are required to cover
manufacturers would be contacted by and Services Administration, lvasquez@ screenings included in the HRSA-
telephone and/or electronic mail 3 times hrsa.gov. supported comprehensive guidelines
per year either to obtain primary data or FOR FURTHER INFORMATION CONTACT: Ms. without charging a co-payment, co-
to verify/validate data. Because the Lisa Vasquez, Genetic Services Branch, insurance, or deductible for plan years
requested data represent data elements Maternal and Child Health Bureau, (i.e., in the individual market, policy
that are monitored or tracked by HRSA, at lvasquez@hrsa.gov or (301) years) beginning on or after the date that
manufacturers as part of routine 443–4948. A copy of the Committee is 1 year from the Secretary’s adoption
inventory management activities, it is Charter and list of the current of the condition for screening.
anticipated that for most manufacturers, membership can be obtained by Nominations: HRSA is requesting
the estimated time required of accessing the Advisory Committee Web nominations to fill three (3) positions
manufacturers to complete the data site at http://www.hrsa.gov/ for voting members to serve on the
request will not exceed 30 minutes per advisorycommittees/mchbadvisory/ Committee. Nominations of potential
request cycle. heritabledisorders. candidates for consideration are being
sought for individuals who are medical,
Dated: June 22, 2015. SUPPLEMENTARY INFORMATION: The technical, public health, or scientific
Leslie Kux, Committee is chartered under section professionals with special expertise in
Associate Commissioner for Policy. 1111 of the Public Health Service (PHS) the field of heritable disorders or in
[FR Doc. 2015–15641 Filed 6–25–15; 8:45 am] Act, 42 U.S.C. 300b–10, as amended by providing screening, counseling, testing,
BILLING CODE 4164–01–P
the Newborn Screening Saves Lives or specialty services for newborns and
Reauthorization Act of 2015 (Act). The children at risk for heritable disorders;
Committee was established in 2003 to who have expertise in ethics (i.e.,
DEPARTMENT OF HEALTH AND advise the Secretary of the U.S. bioethics) and infectious diseases and
HUMAN SERVICES Department of Health and Human who have worked and published
Services regarding newborn screening material in the area of newborn
Health Resources and Services tests, technologies, policies, guidelines, screening; members of the public having
Administration and programs for effectively reducing special expertise about or concern with
morbidity and mortality in newborns heritable disorders; or members from
Advisory Committee on Heritable and children having or at risk for such federal agencies, public health
Disorders in Newborns and Children heritable disorders. In addition, the constituencies, and medical
Request for Nominations Committee provides advice and professional societies as determined to
recommendations to the Secretary be necessary by the Secretary. Interested
AGENCY: Health Resources and Services
concerning the grants and projects applicants may self-nominate or be
Administration, HHS.
authorized under section 1109 of the nominated by another individual and/or
ACTION: Notice of request for PHS Act and technical information to organization.
nominations. develop policies and priorities for Individuals selected for appointment
grants, including those that will to the Committee will be invited to
SUMMARY: The Health Resources and enhance the ability of the state and local serve for up to 4 years. Members who
Services Administration (HRSA) is health agencies to provide for newborn are not federal officers or permanent
seeking nominations of qualified and child screening, counseling and federal employees are appointed as
candidates to be considered for health care services for newborns, and special government employees and
appointment as members of the children having or at risk for heritable receive a stipend and reimbursement for
Advisory Committee on Heritable disorders. per diem and any travel expenses
Disorders in Newborns and Children The Committee is governed by the incurred for attending Committee
(Committee). The Committee provides provisions of Public Law 92–463, as meetings and/or conducting other
advice, recommendations, and technical amended (5 U.S.C. App. 2), and 41 CFR business on behalf of the Committee, as
information about aspects of heritable part 102–3, which set forth standards for authorized by section 5 U.S.C. 5703 for
disorders and newborn and childhood the formation and use of advisory persons employed intermittently in
screening to the Secretary of Health and committees. The Committee reviews government service. Members who are
Human Services. HRSA is seeking and reports regularly on newborn and officers or employees of the United
nominations of qualified candidates to childhood screening practices for States Government shall not receive
fill three positions on the Committee. heritable disorders, recommends additional compensation for service on
Authority: Section 1111 of the Public improvements in the national newborn the Committee, but receive per diem
Health Service (PHS) Act, Title XI, and childhood heritable screening and travel expenses incurred for
§ 1111(g)(1) (42 U.S.C. 300b–10(g)(1)), as programs, and recommends conditions attending Committee meetings and/or
amended by the Newborn Screening Saves
tkelley on DSK3SPTVN1PROD with NOTICES
for inclusion in the Recommended conducting other business on behalf of
Lives Reauthorization Act of 2014. The Uniform Screening Panel (RUSP). The
Committee is governed by the Federal
the Committee. Nominees will be
Advisory Committee Act (FACA), as
Committee’s recommendations invited to serve during calendar year
amended (5 U.S.C. App.), and 41 CFR part regarding additional conditions/ 2016.
102–3 and 41 CFR part 102–3, which set inherited disorders for screening that The following information must be
forth standards for the formation and use of have been adopted by the Secretary are included in the package of materials
advisory committees. included in the RUSP and constitute submitted for each individual being
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![36826 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
nominated for consideration: (1) A Dates and Times: July 13, 2015, 8:30 Health Bureau, telephone: (301) 443–
statement that clearly states the name a.m.–5:30 p.m. (EST), July 14, 2015, 8:30 0543, or email: David.delaCruz@
and affiliation of the nominee, the basis a.m.–3:30 p.m. (EST). hrsa.hhs.gov.
for the nomination (i.e., specific Place: Virtual via Webinar URL:
Jackie Painter,
attributes such as expertise in bioethics, https://hrsa.connectsolutions.com/
evidence review, public health, sacim_seminar_200/. Call-In Number: Director, Division of the Executive Secretariat.
laboratory, maternal and child health, or 1.888.942.8170. Passcode: 3494113. [FR Doc. 2015–15741 Filed 6–25–15; 8:45 am]
clinical expertise in heritable disorders, Status: The meeting is open to the BILLING CODE 4165–15–P
which qualify the nominee for service in public with attendance limited to
this capacity), and that the nominee is availability of call-in lines. For more
willing to serve as a member of the details and registration, please visit the DEPARTMENT OF HEALTH AND
Committee; (2) the nominee’s name, ACIM Web site: http://www.hrsa.gov/ HUMAN SERVICES
address, and daytime telephone number advisorycommittees/mchbadvisory/
and the home/or work address, National Institutes of Health
InfantMortality/index.html).
telephone number, and email address; Purpose: The Committee provides Prospective Grant of Exclusive
and (3) a current copy of the nominee’s advice and recommendations to the License: The Development of an Anti-
curriculum vitae. Nomination packages Secretary of Health and Human Services TSLPR Chimeric Antigen Receptor
may be summited directly by the on the following: Department of Health (CAR) for the Treatment of Human
individual being nominated or by the and Human Services’ programs that Cancers
person/organization recommending the focus on reducing infant mortality and
candidate. improving the health status of infants AGENCY: National Institutes of Health,
The Department of Health and Human and pregnant women; and factors HHS.
Services will make every effort to ensure affecting the continuum of care with ACTION: Notice.
that the membership of the Committee respect to maternal and child health
is fairly balanced in terms of points of care. The Committee focuses on SUMMARY: This is notice, in accordance
view represented. Every effort is made outcomes following childbirth; with 35 U.S.C. 209 and 37 CFR part 404,
to ensure that individuals from a broad strategies to coordinate myriad federal, that the National Institutes of Health,
representation of geographic areas, state, local, and private programs and Department of Health and Human
gender, ethnic and minority groups, as efforts that are designed to deal with the Services, is contemplating the grant of
well as individuals with disabilities are health and social problems impacting an exclusive license to practice the
given consideration for membership. infant mortality; and the inventions embodied in U.S. Provisional
Appointments shall be made without implementation of the Healthy Start Patent Application 61/912,948 entitled
discrimination on the basis of age, program and Healthy People 2020 infant ‘‘Thymic Stromal Lymphopoietin
ethnicity, gender, sexual orientation, mortality objectives. Receptor-Specific Chimeric Antigen
and cultural, religious, or Agenda: Topics that will be discussed Receptors and Methods Using Same’’
socioeconomic status. include the following: HRSA Update; [HHS Ref. E–008–2014/0–US–01], U.S.
Individuals who are selected to be MCHB Update; Healthy Start Program Provisional Patent Application 61/
considered for appointment will be Update; the PREEMIE Act; and, ACIM’s 991,697 entitled ‘‘Thymic Stromal
required to provide detailed information recommendations for the HHS National Lymphopoietin Receptor-Specific
regarding their financial holdings, Strategy to Address Infant Mortality, Chimeric Antigen Receptors and
consultancies, and research grants or specifically, Strategy 5: Invest in Methods Using Same’’ [HHS Ref. E–
contracts. Disclosure of this information adequate data, monitoring, and 008–2014/1–US–01], PCT Patent
is necessary in order to determine if the surveillance systems to measure access, Application PCT/US2014/063096
selected candidate is involved in any quality, and outcomes. entitled ‘‘Thymic Stromal
activity that may pose a potential Proposed agenda items are subject to Lymphopoietin Receptor-Specific
conflict with the official duties to be change as priorities dictate. The most Chimeric Antigen Receptors and
performed as a member of the current agenda will be posted on the Methods Using Same’’ [HHS Ref. E–
Committee. ACIM Web site. 008–2014/2–PCT–01], and all related
Jackie Painter, Time will be provided for public continuing and foreign patents/patent
Director, Division of the Executive Secretariat. comments limited to 5 minutes each. applications for the technology family,
Comments are to be submitted in to Lentigen Technology, Inc. The patent
[FR Doc. 2015–15744 Filed 6–25–15; 8:45 am]
writing no later than 5:00 p.m. EST on rights in these inventions have been
BILLING CODE 4165–15–P
Friday July 3, 2015. assigned to and/or exclusively licensed
FOR FURTHER INFORMATION CONTACT: to the Government of the United States
DEPARTMENT OF HEALTH AND Anyone requiring information regarding of America.
HUMAN SERVICES the Committee should contact Michael The prospective exclusive licensed
C. Lu, M.D., M.P.H., Executive territory may be worldwide, and the
Health Resources and Services Secretary, ACIM, Health Resources and field of use may be limited to:
Administration Services Administration, Room 18 W, ‘‘The development of a TSLPR–CAR-
Parklawn Building, 5600 Fishers Lane, based immunotherapy using chimeric
Advisory Committee on Infant Rockville, Maryland 20857, telephone: antigen receptors (CARs) having:
Mortality; Notice of Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
(301) 443–2170. (1) The complementary determining
In accordance with section 10(a)(2) of Individuals who are submitting public region (CDR) sequences of either
the Federal Advisory Committee Act comments or who have questions (a) the anti-TSLPR antibody known as
(Pub. L. 92–463), notice is hereby given regarding the meeting and location 2D10 or
of the following meeting: should contact David S. de la Cruz, (b) the anti-TSLPR antibody known as
Name: Advisory Committee on Infant Ph.D., M.P.H., ACIM Designated Federal 3G11; and
Mortality (ACIM). Official, HRSA, Maternal and Child (2) a T cell signaling domain
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Document Created: 2015-12-15 14:15:40
Document Modified: 2015-12-15 14:15:40
| 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 of request for nominations. | |
| Dates | Written nominations for membership on the Committee must be received on or before July 27, 2015. | |
| Contact | Ms. Lisa Vasquez, Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at [email protected] or (301) 443-4948. A copy of the Committee Charter and list of the current membership can be obtained by accessing the Advisory Committee Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/ heritabledisorders. | |
| FR Citation | 80 FR 36825 |
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