Secretary's Advisory Committee on Heritable Disorders in Newborns and Children, 35698-35699 [2012-14499]

Download as PDF 35698 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—ABBREVIATED NEW DRUG APPLICATION (ANDA) NUMBERS WITH PRODUCT NAMES—Continued ANDA No. 86789 86794 86799 86838 86839 86868 86882 86897 86921 86970 86976 86991 86999 87000 87041 87064 87069 87096 87097 87098 87099 87106 87112 87116 87123 87124 87125 87134 87166 87172 87198 87379 87443 Product name ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ ........................................................ Estradiol valerate. Dipyridamole. Atropine sulfate; phenobarbital. Pentaerythritol tetranitrate. Isosorbide dinitrate. Chlorpromazine hydrochloride. Hydrocortisone. Phenobarbital; hyoscyamine hydrobromide; atropine sulfate; scopolamine hydrobromide. Chlordiazepoxide hydrochloride; clidinum bromide. Aminophylline. Doxylamine succinate; pyridoxine hydrochloride. Probenecid. Butalbital; aspirin; phenacetin; caffeine. Hydralazine hydrochloride. Phendimetrazine tartrate. Piperazine citrate. Sulfisoxazole acetyl. Phentermine hydrochloride. Phentermine hydrochloride. Phentermine hydrochloride. Phentermine hydrochloride. Ergotamine tartrate; caffeine. Spironolactone. Reserpine; chlorothiazide. Benzthiazide. Benzthiazide. Diphenhydramine hydrochloride. Promethazine hydrochloride. Phentolamine hydrochloride. Theophylline. Belladonna alkaloid malates, l-; phenobarbital. Quinidine gluconate. Homatropine methylbromide; phenobarbital. Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. Authority: Section 1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b–10, as amended. The SACHDNC also 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 sets forth standards for the formation and use of advisory committees. [FR Doc. 2012–14476 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P Health Resources and Services Administration Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). AGENCY: Notice of Request for Nominations of Non-Voting Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) members to serve as representatives of organizations or interest groups. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: HRSA is requesting applications to fill three (3) vacancies for non-voting organizational representatives on the SACHDNC. SUMMARY: VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 The agency must receive written applications from nominees (including a letter of support from an appropriate official of the organization with which affiliated) or the nominee’s organization, on or before August 1, 2012. ADDRESSES: Submit written applications to Sara Copeland, M.D., Designated Federal Official (DFO), SACHDNC; and, Chief, Genetic Services Branch, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Applications may also be sent to Screening@hrsa.hhs.gov. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Debi Sarkar, M.P.H., Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at dsarkar@hrsa.gov or (301) 443–1080. A copy of the SACHDNC Charter and list of the current membership may be obtained by contacting Ms. Sarkar or by accessing FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 the SACHDNC Web site at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders/. SUPPLEMENTARY INFORMATION: The SACHDNC is directed to review and report regularly on newborn and childhood screening practices for heritable disorders and recommend improvements in the national newborn and childhood heritable screening programs. The SACHDNC provides the Secretary with recommendations, advice, and technical information regarding the application of technologies, policies, guidelines, and standards for: (a) Effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders; and (b) enhancing 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. Specifically, HRSA is requesting applications for three (3) non-voting organizational representatives to serve on the SACHDNC: Two (2) at large representatives of a public health constituency, medical professional E:\FR\FM\14JNN1.SGM 14JNN1 pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices society or national advocacy organization and one (1) representative of a public health professional organization. Non-voting representatives provide a perspective unique to the SACHDNC based on their organizations’ or interest groups’ subject area of expertise, and each nominee selection is based on the organization’s/interest group’s mission and relevancy to the SACHDNC’s purpose (e.g., primary care, pediatrics, newborn screening, genetics and other relevant specialty expertise). Eligible organizations should represent broad constituencies affected or impacted by the work of the SACHDNC, as noted in the SACHDNC Charter. Applicants eligible for consideration include representatives of the following organizations: (a) Medical, technical, public health, or scientific organizations with special expertise in the field of heritable disorders or (b) organizations that provide screening, counseling, testing, or specialty services for newborns and children at risk for heritable disorders. Organizations will also be chosen based on perspectives and expertise not currently represented, or with expiring terms, that serve to increase the knowledge base of the SACHDNC. Applicants are requested to submit a written application to the DFO. Applications must contain the following: • Letter of nomination stating the organization’s: Æ Name and mission statement; Æ Outline of the perspective and expertise provided by the nominated organization and why this perspective and expertise would benefit the SACHDNC; and Æ Description of how the SACHDNC’s work affects and/or impacts the nominated organization and its constituency. • Contact information: Point of contact name, address, telephone number, and Web site of the organization; • Portfolio of organizational projects, programs and products that are of importance to the SACHDNC’s work; • Organization’s commitment to provide expert input into the decisionmaking process of the SACHDNC; • Organization’s detailed information concerning any possible conflicts of interest relative to both the organization and the proposed organizational representative (e.g., current or anticipated employment, consultancies, research grants, or contracts); • Organization’s commitment to support a representative to attend all SACHDNC meetings; VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 • Organization’s commitment to ensure active contribution to and dissemination of SACHDNC activities and recommendations to its representative constituencies; • Statement affirming that the organization: (a) Wishes to serve as a representative to the SACHDNC, and (b) has no conflict of interest that would preclude informing the SACHDNC in a fair and balanced manner; • Organization’s description clearly identifying how the organizational perspective and expertise would serve to increase the knowledge base of the SACHDNC; and • SACHDNC’s professional impact on the organization and its stakeholders. Please submit written nominations no later than August 1, 2012. The two (2) at large organizational representatives will be invited to contribute to the SACHDNC for terms of not more than 2 years with an opportunity to re-apply to serve after the 2-year term has expired. The public health professional organization will be invited to have a representative contribute to the SACHDNC for terms of not more than 4 years with an opportunity to re-apply to serve after the 4-year term has expired. Selected organizations will have their representatives begin serving their term in January 2013. Whenever possible, organizational representatives to the SACHDNC shall have expertise in dealing with heritable disorders and genetic diseases affecting racially, ethnically, and geographically diverse populations of newborns served by State newborn screening programs. HHS will ensure that SACHDNC members equitably reflect geographical location and gender distribution, provided that Committee effectiveness would not be impaired. Appointments shall be made without regard to age, ethnicity, gender, or sexual orientation, and cultural, religious, or socioeconomic status. Dated: June 7, 2012. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2012–14499 Filed 6–13–12; 8:45 am] BILLING CODE 4165–15–P PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 35699 DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Proposed Information Collection; Request for Public Comment: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions Indian Health Service, HHS. Notice. AGENCY: ACTION: In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions (OMB No. 0917–0028). Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917–0028, ‘‘Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions.’’ Although there was a change on the form ‘‘Addendum to Declaration for Federal Employment, Child care and Indian Child care Worker Positions’’ (OMB No. 0917–0028), where the item number 15a was changed to 16 to reflect a change in the same item number on the ‘‘Declaration for Federal Employment’’ form (OPM OF 306; OMB No. 3206– 0182), there are no program changes or adjustments in burden hours. Form Number: OMB No. 0917–0028. Forms: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of the collection of information as required by Section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law (Pub. L.) 101–630, 104 Stat. 4544, and 25 United States Code (U.S.C.) §§ 3201–3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. 25 U.S.C. § 3207 requires regulations prescribing the SUMMARY: E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35698-35699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Secretary's Advisory Committee on Heritable Disorders in Newborns 
and Children

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

ACTION: Notice of Request for Nominations of Non-Voting Secretary's 
Advisory Committee on Heritable Disorders in Newborns and Children 
(SACHDNC) members to serve as representatives of organizations or 
interest groups.

-----------------------------------------------------------------------

SUMMARY: HRSA is requesting applications to fill three (3) vacancies 
for non-voting organizational representatives on the SACHDNC.

    Authority: Section 1111 of the Public Health Service (PHS) Act, 
42 U.S.C. 300b-10, as amended. The SACHDNC also 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 sets forth standards for the formation and 
use of advisory committees.

DATES: The agency must receive written applications from nominees 
(including a letter of support from an appropriate official of the 
organization with which affiliated) or the nominee's organization, on 
or before August 1, 2012.

ADDRESSES: Submit written applications to Sara Copeland, M.D., 
Designated Federal Official (DFO), SACHDNC; and, Chief, Genetic 
Services Branch, Maternal and Child Health Bureau, Health Resources and 
Services Administration, Room 18A-19, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857. Applications may also be sent to 
Screening@hrsa.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Debi Sarkar, M.P.H., Genetic Services 
Branch, Maternal and Child Health Bureau, HRSA, at dsarkar@hrsa.gov or 
(301) 443-1080. A copy of the SACHDNC Charter and list of the current 
membership may be obtained by contacting Ms. Sarkar or by accessing the 
SACHDNC Web site at https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/.

SUPPLEMENTARY INFORMATION: The SACHDNC is directed to review and report 
regularly on newborn and childhood screening practices for heritable 
disorders and recommend improvements in the national newborn and 
childhood heritable screening programs.
    The SACHDNC provides the Secretary with recommendations, advice, 
and technical information regarding the application of technologies, 
policies, guidelines, and standards for: (a) Effectively reducing 
morbidity and mortality in newborns and children having, or at risk 
for, heritable disorders; and (b) enhancing 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.
    Specifically, HRSA is requesting applications for three (3) non-
voting organizational representatives to serve on the SACHDNC: Two (2) 
at large representatives of a public health constituency, medical 
professional

[[Page 35699]]

society or national advocacy organization and one (1) representative of 
a public health professional organization. Non-voting representatives 
provide a perspective unique to the SACHDNC based on their 
organizations' or interest groups' subject area of expertise, and each 
nominee selection is based on the organization's/interest group's 
mission and relevancy to the SACHDNC's purpose (e.g., primary care, 
pediatrics, newborn screening, genetics and other relevant specialty 
expertise). Eligible organizations should represent broad 
constituencies affected or impacted by the work of the SACHDNC, as 
noted in the SACHDNC Charter.
    Applicants eligible for consideration include representatives of 
the following organizations: (a) Medical, technical, public health, or 
scientific organizations with special expertise in the field of 
heritable disorders or (b) organizations that provide screening, 
counseling, testing, or specialty services for newborns and children at 
risk for heritable disorders. Organizations will also be chosen based 
on perspectives and expertise not currently represented, or with 
expiring terms, that serve to increase the knowledge base of the 
SACHDNC.
    Applicants are requested to submit a written application to the 
DFO. Applications must contain the following:
     Letter of nomination stating the organization's:
    [cir] Name and mission statement;
    [cir] Outline of the perspective and expertise provided by the 
nominated organization and why this perspective and expertise would 
benefit the SACHDNC; and
    [cir] Description of how the SACHDNC's work affects and/or impacts 
the nominated organization and its constituency.
     Contact information: Point of contact name, address, 
telephone number, and Web site of the organization;
     Portfolio of organizational projects, programs and 
products that are of importance to the SACHDNC's work;
     Organization's commitment to provide expert input into the 
decision-making process of the SACHDNC;
     Organization's detailed information concerning any 
possible conflicts of interest relative to both the organization and 
the proposed organizational representative (e.g., current or 
anticipated employment, consultancies, research grants, or contracts);
     Organization's commitment to support a representative to 
attend all SACHDNC meetings;
     Organization's commitment to ensure active contribution to 
and dissemination of SACHDNC activities and recommendations to its 
representative constituencies;
     Statement affirming that the organization: (a) Wishes to 
serve as a representative to the SACHDNC, and (b) has no conflict of 
interest that would preclude informing the SACHDNC in a fair and 
balanced manner;
     Organization's description clearly identifying how the 
organizational perspective and expertise would serve to increase the 
knowledge base of the SACHDNC; and
     SACHDNC's professional impact on the organization and its 
stakeholders.

Please submit written nominations no later than August 1, 2012. The two 
(2) at large organizational representatives will be invited to 
contribute to the SACHDNC for terms of not more than 2 years with an 
opportunity to re-apply to serve after the 2-year term has expired. The 
public health professional organization will be invited to have a 
representative contribute to the SACHDNC for terms of not more than 4 
years with an opportunity to re-apply to serve after the 4-year term 
has expired. Selected organizations will have their representatives 
begin serving their term in January 2013.
    Whenever possible, organizational representatives to the SACHDNC 
shall have expertise in dealing with heritable disorders and genetic 
diseases affecting racially, ethnically, and geographically diverse 
populations of newborns served by State newborn screening programs. HHS 
will ensure that SACHDNC members equitably reflect geographical 
location and gender distribution, provided that Committee effectiveness 
would not be impaired. Appointments shall be made without regard to 
age, ethnicity, gender, or sexual orientation, and cultural, religious, 
or socioeconomic status.

    Dated: June 7, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-14499 Filed 6-13-12; 8:45 am]
BILLING CODE 4165-15-P
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