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]
-----------------------------------------------------------------------
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