Notice of Listing of Grants for Research Projects, 56159-56162 [E6-15729]
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
nanotechnology materials that pertain to
FDA-regulated products. FDA is
interested in learning about the kinds of
new nanotechnology material products
under development in the areas of foods
(including dietary supplements), food
and color additives, animal feeds,
cosmetics, drugs and biologics, and
medical devices, whether there are new
or emerging scientific issues that should
be brought to FDA’s attention, and any
other scientific issues about which the
regulated industry, academia, and the
interested public may wish to inform
FDA concerning the use of
nanotechnology materials in FDAregulated products.
DATES AND TIMES: The public meeting
will be held October 10, 2006, from 9
a.m. to 5 p.m.
REGISTRATION: You may preregister to
attend or make a presentation at https://
www.fda.gov/nanotechnology/.
Preregistration to make a presentation
will close on September 29, 2006;
however, there will be onsite
registration to attend on a first-come,
first-served basis until the room
capacity is reached. Onsite registration
will be open at the meeting site at 8:30
a.m. on October 10. Once room capacity
is reached, individuals will be offered
the opportunity to observe the meeting
from an overflow room located at the
meeting site.
If time permits, there will be an open
public session. Individuals who have
not preregistered to make a presentation
can register onsite if they wish to
present public comments. While every
effort will be made to provide an open
public session after all preregistered
speakers have made presentations, it is
recommended that you preregister if
you would like to make a presentation.
Onsite registration to make a
presentation will be taken on a firstcome, first-served basis. Individuals
who register at the meeting to speak
may be allotted less time to speak than
preregistered speakers, depending on
the number of registrants.
We will post the agenda at https://
www.fda.gov/nanotechnology/ prior to
the meeting.
ADDRESSES: The public meeting will be
held at the Natcher Auditorium,
National Institutes of Health Campus
(NIH), 9000 Rockville Pike, bldg. 45,
Bethesda, MD. We will also post the
address for the meeting at https://
www.fda.gov/nanotechnology/. Note
that parking is limited on the NIH
Campus and that security procedures
are in effect. For further information on
parking and security see https://
www.nih.gov/about/visitorsecurity.htm.
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Written or electronic comments may
be submitted by November 10, 2006.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/
ecomments. All comments should be
identified with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Poppy Kendall, Food and Drug
Administration (HF–11), 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360, FAX: 301–594–6777, e-mail:
poppy.kendall@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding a Public
Meeting?
Previous Federal Register Notices (71
FR 19523, April 14, 2006; 71 FR 46232,
August 11, 2006) contain detailed
supplemental information regarding the
rationale and background for the
meeting.
For more information about FDA’s
role regarding nanotechnology products,
see our Web page at https://www.fda.gov/
nanotechnology/.
II. How Can You Participate?
You can participate through oral
presentation at the meeting or through
written or electronic material submitted
to the docket. The length of the
presentations will be determined by the
number of speakers who preregister and
the time available. Based on the requests
received so far, the presentations are
likely to be less than 8 minutes long. In
order to maximize the number of people
who have the opportunity to present
their views at this public meeting, each
individual or organization will be
limited to one opportunity to present
views at the meeting. However, written
material of any length can be submitted
to the docket.
Individuals and organizations with
common interests are encouraged to
consolidate or coordinate their
presentations. FDA will give the
registered speakers an estimated
timeframe for their presentations by
October 4 through email to the address
provided during preregistration. Persons
should arrive early to make sure that
they are present to make their
presentation in case we are ahead of
schedule.
In a previous notice we indicated the
possibility of holding concurrent
sessions. However, based on the number
of requests for presentation received so
far it appears that all can be
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accommodated by one general session.
A final decision on whether there will
be concurrent sessions will be made
following the cutoff date for registration
and will be communicated through the
posted agenda at https://www.fda.gov/
nanotechnology/ and e-mail to
registered speakers.
We ask that you preregister by
September 29 (see REGISTRATION) if you
intend to provide an oral presentation.
If time permits, there will be an open
public session at the meeting. However,
individuals who register at the meeting
to speak may be allotted less time to
speak than preregistered speakers,
depending on the number of registrants.
The information provided during
preregistration will help us determine
further how to organize the day.
III. Will Meeting Transcripts Be
Available?
Following the meeting, transcripts
will be available for review at the
Division of Dockets Management (see
ADDRESSES).
IV. How Should You Send Comments
on the Issues?
An open public docket has been
established. Individuals may submit
their comments either in writing or
electronically to the docket. All
comments should include the docket
number found in brackets in the
heading of this document (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals have the option of
submitting one paper copy. Comments
are to be identified with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8242 Filed 9–21–06; 1:22 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Listing of Grants for
Research Projects
National Institutes of Health,
Department of Health and Human
Services.
AGENCY:
ACTION:
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
SUMMARY: Section 52.1(b) of the
regulations governing grants for research
projects, codified at 42 CFR part 52,
authorizes the Secretary of Health and
Human Services to publish periodically
a list of all of the research project grant
programs to which the research project
grant regulations apply. This Notice
provides the most recent list of the
programs covered by the regulations and
supersedes the prior Notice published
on November 25, 2003 (68 FR 66114–
66117).
DATES:
Effective Date: September 26,
2006.
Jerry
Moore, NIH Regulations Officer, Office
of Management Assessment, 6011
Executive Boulevard, Room 601, MSC
7669, Rockville, MD 20892, telephone
301–496–4607 (not a toll-free number),
fax 301–402–0169, e-mail
jm40z@nih.gov.
FOR FURTHER INFORMATION CONTACT:
The
National Institutes of Health (NIH)
published a final rule in the Federal
Register on October 24, 1996 (61 FR
55102–55106), amending the regulations
at 42 CFR part 52, Grants for Research
Projects, which govern Public Health
Service (PHS) research project grants.
We amended the regulations to apply to
all research project grant programs
administered by PHS and its
components, including the programs
administered by NIH, except for grants
for health services research,
demonstrations, and evaluation projects
administered by the Agency for
Healthcare Research and Quality
(AHRQ), to make it unnecessary to
include a long list of programs in the
regulations or to go through the lengthy
process of amending the regulations
each time a new program is established.
At that time, we provided in the
preamble a listing of the applicable
programs and indicated that we would
publish periodically a list of the
research project grant programs to
which the regulations apply, and that
the applicability of the regulations to
new programs would be announced as
PHS components initiated new
programs.
Subsequently, we published the
Notice entitled, ‘‘Notice of Listing of
Grants for Research Projects,’’ in the
Federal Register on November 25, 2003.
In the Notice we provided an updated
list of programs to which the regulations
at part 52 apply that reflected the
addition of new authorities in sections
317J, 317K, 317L, 330E, 399M, 399N,
409E, 434A, 445I, 447B, and 1261 of the
Public Health Service Act (PHS Act), as
amended.
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SUPPLEMENTARY INFORMATION:
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We are now publishing a further
updated list that reflects the addition of
the new authority in subsections (a) and
(f) of section 485D of the PHS Act, as
amended, concerning research in
complementary and alternative
medicine. Specifically, the authority in
subsection (a) concerns the conduct and
support of basic and applied research
(including both intramural and
extramural research), research training,
and dissemination of health information
with respect to identifying,
investigating, and validating
complementary and alternative
treatment, diagnostic and prevention
modalities, and disciplines and systems
of complementary and alternative
medicine. Subsection (f) concerns the
conduct and support of high quality,
rigorous scientific reviewing of
complementary and alternative
medicine modalities, including
outcomes research and investigations,
epidemiological studies, health services
research, basic sciences research,
clinical trials, and other appropriate
research and investigational activities.
The regulations codified at 42 CFR
part 52 apply to all PHS research project
grant programs except for grants for
health services research,
demonstrations, and evaluation projects
administered by the AHRQ.
Specifically, the research project grant
authorities to which the Grants for
Research Projects regulations apply
include:
(1) Research into the cause, diagnosis,
treatment, control, or prevention of the
physical or mental diseases, injuries, or
impairments to human life, as
authorized by sections 301, 302, and
related provisions of the PHS Act (42
U.S.C. 241, 242);
(2) Research into the prevention and
control of childhood lead poisoning, as
authorized under section 301 of the PHS
Act (42 U.S.C. 241);
(3) Epidemiologic studies and Statebased research capacity building
projects for the prevention of primary
and secondary disabilities, as
authorized under section 301 of the PHS
Act (42 U.S.C. 241);
(4) Ecological and epidemiologic
research studies in Lyme disease,
including disease surveillance,
development and evaluation of
prevention and control studies, and
development of improved diagnostic
tests, as authorized under section 301 of
the PHS Act (42 U.S.C. 241);
(5) Research for the development of
knowledge and approaches to the
epidemiology, eitology, diagnosis,
treatment, control, and prevention of
narcotic addiction and intravenous (IV)related AIDS and drug abuse, as
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authorized under sections 301 and 302
of the PHS Act (42 U.S.C. 241, 242);
(6) Investigations to identify strategies
for prevention of childhood deaths from
diarrhea, as authorized under sections
301 and 317(k) of the PHS Act (42
U.S.C. 241, 247b(k));
(7) HIV/AIDS surveillance, HIV
serosurveillance surveys and studies,
and epidemiologic research studies of
AIDS and HIV infection, as authorized
under sections 301 and 317(k) of the
PHS Act (42 U.S.C. 241, 247b(k));
(8) Surveillance and epidemiologic
studies for the prevention of infectious
diseases and injuries in children in
child day care settings, as authorized
under sections 301, 317(k), and 391 of
the PHS Act (42 U.S.C. 241, 247b(k)(3),
280(b));
(9) Research into prevention and
control of tuberculosis, especially
research concerning strains of
tuberculosis resistant to drugs and
research concerning cases of
tuberculosis that affect certain
populations, as authorized by section
317E of the PHS Act (42 U.S.C. 247b–
6);
(10) Research with respect to
education and training for health
professionals and the general public
relating to the effects of folic acid in
preventing birth defects, as authorized
by section 317J of the PHS Act (42
U.S.C. 247b–11);
(11) Research relating to risk factors,
prevention strategies, and the roles of
the family, health care providers, and
the community in safe motherhood, as
authorized by section 317K of the PHS
Act, as amended by section 901 of
Public Law 106–310 (42 U.S.C. 424b–
12);
(12) Epidemiological research on the
prevention of prenatal and postnatal
smoking, alcohol, and illegal drug use,
as authorized by section 317L of the
PHS Act, as amended by section 911 of
Public Law 106–310 (42 U.S.C. 247b–
13);
(13) Research relating to intervention
strategies to improve the lives of
persons with epilepsy, particularly
children, as authorized by section 330E
of the PHS Act, as amended by section
801 of Public Law 106–310 (42 U.S.C.
254c–5);
(14) Injury prevention and control
research, as authorized by section 391 of
the PHS Act (42 U.S.C. 280b);
(15) Research relating to the efficacy
of new screening techniques and
technology, including clinical studies of
screening methods and studies on the
efficacy of new interventions regarding
hearing loss in infants, as authorized by
section 399M of the PHS Act, as
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amended by section 702 of Public Law
106–310 (42 U.S.C. 280g–1);
(16) Research relating to improving
the outcomes among children with
childhood cancers and resultant
secondary conditions, as authorized by
section 399N of the PHS Act, as
amended by section 1101 of Public Law
106–310 (42 U.S.C. 280g–2);
(17) Research on osteoporosis, Paget’s
disease, and related bone disorders, as
authorized by section 409A of the PHS
Act (42 U.S.C. 284e);
(18) Research relating to autoimmune
diseases, as authorized by section 409E
of the PHS Act, as amended by section
1901 of Public Law 106–310 (42 U.S.C.
284i);
(19) Long-term epidemiology studies
relating to type 1 or juvenile diabetes, as
authorized by section 434A of the PHS
Act, as amended by section 402 of
Public Law 106–310 (42 U.S.C. 285c–9);
(20) Biomedical research in areas
relating to Alzheimer’s disease and
related dementias, as authorized by
section 445B of the PHS Act (42 U.S.C.
285e–4);
(21) Clinical research and training to
enhance and promote the translation of
new scientific knowledge into clinical
practice related to the diagnosis, care,
and treatment of individuals with
Alzheimer’s disease, as authorized by
section 445I of the PHS Act (42 U.S.C.
285e–10a);
(22) Clinical research and training to
enhance and promote the translation of
new scientific knowledge into clinical
practice related to the diagnosis, care,
and treatment of individuals with
sexually transmitted diseases, as
authorized by section 447B of the PHS
Act, as amended by section 901 of
Public Law 106–505 (42 U.S.C. 285f–3);
(23) Research relating to medical
rehabilitation, as authorized by section
452 of the PHS Act (42 U.S.C. 285g–4);
(24) Research on clinical and health
services on eye care and diabetes, as
authorized by section 456 of the PHS
Act (42 U.S.C. 285i–1);
(25) Research on multiple sclerosis,
especially research on the effects of
genetics and hormonal changes on the
progress of the disease, as authorized by
section 460 of the PHS Act (42 U.S.C.
285j–3);
(26) Research on the social,
behavioral, and biomedical etiology, the
mental and physical health
consequences, and the social and
economic consequences of alcohol
abuse and alcoholism, as authorized by
464H of the PHS Act (42 U.S.C. 285n);
(27) Health services research activities
with respect to the prevention of alcohol
abuse and treatment of alcoholism, as
authorized by section 464H of the PHS
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Act (42 U.S.C. 285n) and as defined in
section 409 of the PHS Act (42 U.S.C.
284d);
(28) Research under the Medication
Development Program to encourage and
promote the development and use of
medications to treat drug addiction; and
to collect, analyze, and disseminate
data, as authorized by section 464P of
the PHS Act (42 U.S.C. 285o–4);
(29) Research on health-related
educational technologies, on medical
library science and related activities,
and for the development or
dissemination of new knowledge,
techniques, systems, and equipment for
processing, storing, retrieving, and
distributing information pertaining to
health sciences, as authorized by section
473 of the PHS Act (42 U.S.C. 286b–4);
(30) Research with respect to
identifying, investigating, and validating
complementary and alternative
treatment, diagnostic and prevention
modalities, disciplines and systems of
complementary and alternative
medicine, as authorized by section 485D
(a) and (f) of the PHS Act, as amended
(42 U.S.C. 287c–21(a), (f));
(31) Research in the biomedical,
contraceptive, development, behavioral
and program implementation fields
related to family planning and
population, as authorized by section
1004 of the PHS Act (42 U.S.C. 300a–
2);
(32) Basic and applied research
regarding traumatic brain injury,
including the development,
modification, and evaluation of
therapies and programs of rehabilitation
toward reaching or restoring normal
capabilities, as authorized by section
1261 of the PHS Act, as amended by
section 1301 of Public Law 106–310 (42
U.S.C. 300d–61);
(33) Research on the causes,
consequences, and approaches of coping
with adolescent sexual relations,
contraceptive use, pregnancy, and
parenthood, as authorized by section
2008 of the PHS Act (42 U.S.C. 300z–
7);
(34) Research relating to the
evaluation of drug treatments for AIDS
not approved by the Commissioner of
Food and Drugs, as authorized by
section 2314 of the PHS Act (42 U.S.C.
300cc–14);
(35) International research relating to
the development and evaluation of
vaccines and treatments for AIDS, as
authorized by section 2315 of the PHS
Act (42 U.S.C. 300cc–15);
(36) Long-term research into
treatments for AIDS, as authorized by
section 2320 of the PHS Act (42 U.S.C.
300cc–20);
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(37) Research relating to AIDS
conducted outside the United States by
qualified foreign professionals and
collaborative research involving
American and foreign participants, as
authorized by section 2354 of the PHS
Act (42 U.S.C. 300cc–41);
(38) Basic research to identify,
characterize, and quantify risks to
human health from air pollutants, as
authorized by section 103 of the Clean
Air Act, as amended (42 U.S.C. 7403);
(39) Electronic product radiation
control research programs designed to
protect the public health and safety
from electronic product radiation, as
authorized by section 532 of the Federal
Food, Drug, and Cosmetic Act, as
amended (21 U.S.C. 360ii);
(40) Research into areas where a
microgravity environment may
contribute to significant progress in the
understanding and treatment of diseases
and other medical conditions, as
authorized by section 603 of the
National Aeronautics and Space
Administration Authorization Act,
Fiscal Year 1993 (42 U.S.C. 2487b);
(41) Support for radiation studies and
research, as authorized under section
301 of the PHS Act (42 U.S.C. 241) and
by section 20(a) of the Occupational
Safety and Health Act of 1970 (29 U.S.C.
669(a));
(42) Research on occupational safety
and health problems in industry, as
authorized by section 20(a) of the
Occupational Safety and Health Act of
1970 (29 U.S.C. 669(a)) and section 501
of the Federal Coal Mine Health and
Safety Act of 1969 (30 U.S.C. 951); and
(43) Research to stimulate healthrelated technological innovation
especially through the use of small
business, minority, and disadvantaged
firms and increased private sector
commercialization of innovations
derived from Federal research and
development, as authorized under
section 301 of the PHS Act (42 U.S.C.
241), in accordance with the procedures
prescribed pursuant to section 2[9] of
the Small Business Innovation
Development Act of 1982, as amended
(15 U.S.C. 638).
The Catalog of Federal Domestic
Assistance (CFDA) numbered programs
affected by title 42 of the Code of Federal
regulations, part 52, are:
93.113—Biological Response to
Environmental Health Hazards
93.114—Applied Toxicological Research and
Testing
93.115—Biometry and Risk Estimation—
Health Risks from Environmental
Exposures
93.118—Acquired Immunodeficiency
Syndrome (AIDS) Activity
93.121—Oral Diseases and Disorders
Research
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
93.135—Centers for Research and
Demonstration for Health Promotion and
Disease Prevention
93.136—Injury Prevention and Control
Research and State and Community Based
Programs
93.172—Human Genome Research
93.173—Research Related to Deafness and
Communication Disorders
93.184—Disabilities Prevention
93.213—Research and Training in
Complementary and Alternative Medicine
93.242—Mental Health Research Grants
93.262—Occupational Safety and Health
Program
93.271—Alcohol Research Career
Development Awards for Scientists and
Clinicians
93.273—Alcohol Research Programs
93.279—Drug Abuse and Addiction Research
Programs
93.281—Mental Health Research Career/
Scientist Development Awards
93.283—Centers for Disease Control and
Prevention—Investigations and Technical
Assistance
93.361—Nursing Research
93.389—National Center for Research
Resources
93.390—Academic Research Enhancement
Award
93.393—Cancer Cause and Prevention
Research
93.394—Cancer Detection and Diagnosis
Research
93.395—Cancer Treatment Research
93.396—Cancer Biology Research
93.821—Biophysics and Physiological
Sciences Research
93.837—Heart and Vascular Diseases
Research
93.838—Lung Diseases Research
93.839—Blood Diseases and Resources
Research
93.846—Arthritis, Musculoskeletal and Skin
Diseases Research
93.847—Diabetes, Endocrinology and
Metabolic Research
93.848—Digestive Diseases and Nutrition
Research
93.849—Kidney Diseases, Urology and
Hematology Research
93.853—Clinical Research Related to
Neurological Disorders
93.855—Allergy, Immunology, and
Transplantation Research
93.856—Microbiology and Infectious
Diseases Research
93.859—Biomedical Research and Research
Training
93.865—Child Health and Human
Development Extramural Research
93.866—Aging Research
93.867—Vision Research
93.879—Medical Library Assistance
93.941—HIV Demonstration, Research,
Public and Professional Education Projects
93.942—Research, Treatment and Education
Programs on Lyme Disease in the United
States
93.943—Epidemiologic Research Studies of
Acquired Immunodeficiency Syndrome
(AIDS) and Human Immunodeficiency
Virus (HIV) Infection in Selected
Population Groups
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93.947—Tuberculosis Demonstration,
Research, Public and Professional
Education
Dated: September 19, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
Approved: September 19, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. E6–15729 Filed 9–25–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Evaluation of the
Project Rehabilitation and Restitution
Program (OMB No. 0930–0248)—
Revision
The Rehabilitation and Restitution
initiative of the Substance Abuse and
Mental Health Services
Administration’s (SAMHSA) Center for
Substance Abuse Treatment seeks to
reduce recidivism and increase
psychosocial functioning and pro-social
lifestyle among substance abusing
offenders that have pled to or been
convicted of a single felony. Hypotheses
of the study are that providing
intensive, long-term case management
services will facilitate a pro-social
lifestyle leading to higher rates of
sealing or expunging of criminal records
and that the prospect of stigma
reduction provided by a sealed criminal
record will motivate offenders to remain
crime and drug free in order to achieve
a felony-free criminal record.
The project consists of (1) providing
technical assistance to develop and
implement an enhanced model for case
management services, and (2) evaluating
of the effectiveness of the case
management model in increasing the
number of people that have their
records sealed or maintain eligibility to
have their records sealed. The study is
confined to jurisdictions with statutes
permitting records to be sealed within
the remaining three-year parameters of
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the study. Two counties in Ohio, one
involving an urban setting (Cuyahoga
county which includes the city of
Cleveland) and the other a rural setting
(Clermont county adjacent to Northern
Kentucky) were awarded by SAMHSA
in 2002 in response to the original
SAMHSA Request for Applications
(RFA).
Target populations, drawn from
Cuyahoga and Clermont County Court of
Common Pleas Probation Departments,
are first-time felons that are eligible to
have their felony records sealed, have a
diagnosis of substance dependence or
abuse, and will receive case
management services, including
treatment referral, through each
County’s Treatment Accountability for
Safer Communities (TASC) agency.
Technical assistance to participating
counties is provided to (1) develop a
strengths-based case management model
designed to increase the proportion of
offenders that achieve record
expungement or maintain eligibility to
have their felony records sealed, and (2)
involve the various stake holders, such
as case managers, probation officers and
administrators, prosecutors, public
defenders, judges, and treatment
providers in the implementation of the
case management model. A formative
evaluation provides feedback on the
implementation of the program. A
systems evaluation examines the
services offered to the felons, and
changes in attitudes towards sealing
records on the part of critical
stakeholders, such as prosecutors,
judges and service providers, and
criminal justice systemic evolution. An
outcomes evaluation examines the effect
of the case management model on
maintaining eligibility to have records
sealed, and social, psychological and
health status, HIV risk behavior, and the
proportion of subjects who have their
records sealed.
In Cuyahoga County a longitudinal
study examines two groups of randomly
assigned subjects: An intent-to-treat,
experimental group participates in a
strengths-based case management model
during the first six months of a one-year
period of judicial supervision followed
by three years of outreach services
availability through a faith-based
community organization; and a control
group receives treatment as usual,
consisting of the regular TASC case
management model now in place with
no outreach service availability. Each
group is stratified by Standard Court
Referral (SCR), i.e., convicted first-time
felons that must remain crime-free for
three years after release from probation
to maintain eligibility to apply for
expungement; and Felony Diversion
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56159-56162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15729]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Listing of Grants for Research Projects
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice.
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[[Page 56160]]
SUMMARY: Section 52.1(b) of the regulations governing grants for
research projects, codified at 42 CFR part 52, authorizes the Secretary
of Health and Human Services to publish periodically a list of all of
the research project grant programs to which the research project grant
regulations apply. This Notice provides the most recent list of the
programs covered by the regulations and supersedes the prior Notice
published on November 25, 2003 (68 FR 66114-66117).
DATES: Effective Date: September 26, 2006.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, 6011 Executive Boulevard, Room 601,
MSC 7669, Rockville, MD 20892, telephone 301-496-4607 (not a toll-free
number), fax 301-402-0169, e-mail jm40z@nih.gov.
SUPPLEMENTARY INFORMATION: The National Institutes of Health (NIH)
published a final rule in the Federal Register on October 24, 1996 (61
FR 55102-55106), amending the regulations at 42 CFR part 52, Grants for
Research Projects, which govern Public Health Service (PHS) research
project grants. We amended the regulations to apply to all research
project grant programs administered by PHS and its components,
including the programs administered by NIH, except for grants for
health services research, demonstrations, and evaluation projects
administered by the Agency for Healthcare Research and Quality (AHRQ),
to make it unnecessary to include a long list of programs in the
regulations or to go through the lengthy process of amending the
regulations each time a new program is established. At that time, we
provided in the preamble a listing of the applicable programs and
indicated that we would publish periodically a list of the research
project grant programs to which the regulations apply, and that the
applicability of the regulations to new programs would be announced as
PHS components initiated new programs.
Subsequently, we published the Notice entitled, ``Notice of Listing
of Grants for Research Projects,'' in the Federal Register on November
25, 2003. In the Notice we provided an updated list of programs to
which the regulations at part 52 apply that reflected the addition of
new authorities in sections 317J, 317K, 317L, 330E, 399M, 399N, 409E,
434A, 445I, 447B, and 1261 of the Public Health Service Act (PHS Act),
as amended.
We are now publishing a further updated list that reflects the
addition of the new authority in subsections (a) and (f) of section
485D of the PHS Act, as amended, concerning research in complementary
and alternative medicine. Specifically, the authority in subsection (a)
concerns the conduct and support of basic and applied research
(including both intramural and extramural research), research training,
and dissemination of health information with respect to identifying,
investigating, and validating complementary and alternative treatment,
diagnostic and prevention modalities, and disciplines and systems of
complementary and alternative medicine. Subsection (f) concerns the
conduct and support of high quality, rigorous scientific reviewing of
complementary and alternative medicine modalities, including outcomes
research and investigations, epidemiological studies, health services
research, basic sciences research, clinical trials, and other
appropriate research and investigational activities.
The regulations codified at 42 CFR part 52 apply to all PHS
research project grant programs except for grants for health services
research, demonstrations, and evaluation projects administered by the
AHRQ. Specifically, the research project grant authorities to which the
Grants for Research Projects regulations apply include:
(1) Research into the cause, diagnosis, treatment, control, or
prevention of the physical or mental diseases, injuries, or impairments
to human life, as authorized by sections 301, 302, and related
provisions of the PHS Act (42 U.S.C. 241, 242);
(2) Research into the prevention and control of childhood lead
poisoning, as authorized under section 301 of the PHS Act (42 U.S.C.
241);
(3) Epidemiologic studies and State-based research capacity
building projects for the prevention of primary and secondary
disabilities, as authorized under section 301 of the PHS Act (42 U.S.C.
241);
(4) Ecological and epidemiologic research studies in Lyme disease,
including disease surveillance, development and evaluation of
prevention and control studies, and development of improved diagnostic
tests, as authorized under section 301 of the PHS Act (42 U.S.C. 241);
(5) Research for the development of knowledge and approaches to the
epidemiology, eitology, diagnosis, treatment, control, and prevention
of narcotic addiction and intravenous (IV)-related AIDS and drug abuse,
as authorized under sections 301 and 302 of the PHS Act (42 U.S.C. 241,
242);
(6) Investigations to identify strategies for prevention of
childhood deaths from diarrhea, as authorized under sections 301 and
317(k) of the PHS Act (42 U.S.C. 241, 247b(k));
(7) HIV/AIDS surveillance, HIV serosurveillance surveys and
studies, and epidemiologic research studies of AIDS and HIV infection,
as authorized under sections 301 and 317(k) of the PHS Act (42 U.S.C.
241, 247b(k));
(8) Surveillance and epidemiologic studies for the prevention of
infectious diseases and injuries in children in child day care
settings, as authorized under sections 301, 317(k), and 391 of the PHS
Act (42 U.S.C. 241, 247b(k)(3), 280(b));
(9) Research into prevention and control of tuberculosis,
especially research concerning strains of tuberculosis resistant to
drugs and research concerning cases of tuberculosis that affect certain
populations, as authorized by section 317E of the PHS Act (42 U.S.C.
247b-6);
(10) Research with respect to education and training for health
professionals and the general public relating to the effects of folic
acid in preventing birth defects, as authorized by section 317J of the
PHS Act (42 U.S.C. 247b-11);
(11) Research relating to risk factors, prevention strategies, and
the roles of the family, health care providers, and the community in
safe motherhood, as authorized by section 317K of the PHS Act, as
amended by section 901 of Public Law 106-310 (42 U.S.C. 424b-12);
(12) Epidemiological research on the prevention of prenatal and
postnatal smoking, alcohol, and illegal drug use, as authorized by
section 317L of the PHS Act, as amended by section 911 of Public Law
106-310 (42 U.S.C. 247b-13);
(13) Research relating to intervention strategies to improve the
lives of persons with epilepsy, particularly children, as authorized by
section 330E of the PHS Act, as amended by section 801 of Public Law
106-310 (42 U.S.C. 254c-5);
(14) Injury prevention and control research, as authorized by
section 391 of the PHS Act (42 U.S.C. 280b);
(15) Research relating to the efficacy of new screening techniques
and technology, including clinical studies of screening methods and
studies on the efficacy of new interventions regarding hearing loss in
infants, as authorized by section 399M of the PHS Act, as
[[Page 56161]]
amended by section 702 of Public Law 106-310 (42 U.S.C. 280g-1);
(16) Research relating to improving the outcomes among children
with childhood cancers and resultant secondary conditions, as
authorized by section 399N of the PHS Act, as amended by section 1101
of Public Law 106-310 (42 U.S.C. 280g-2);
(17) Research on osteoporosis, Paget's disease, and related bone
disorders, as authorized by section 409A of the PHS Act (42 U.S.C.
284e);
(18) Research relating to autoimmune diseases, as authorized by
section 409E of the PHS Act, as amended by section 1901 of Public Law
106-310 (42 U.S.C. 284i);
(19) Long-term epidemiology studies relating to type 1 or juvenile
diabetes, as authorized by section 434A of the PHS Act, as amended by
section 402 of Public Law 106-310 (42 U.S.C. 285c-9);
(20) Biomedical research in areas relating to Alzheimer's disease
and related dementias, as authorized by section 445B of the PHS Act (42
U.S.C. 285e-4);
(21) Clinical research and training to enhance and promote the
translation of new scientific knowledge into clinical practice related
to the diagnosis, care, and treatment of individuals with Alzheimer's
disease, as authorized by section 445I of the PHS Act (42 U.S.C. 285e-
10a);
(22) Clinical research and training to enhance and promote the
translation of new scientific knowledge into clinical practice related
to the diagnosis, care, and treatment of individuals with sexually
transmitted diseases, as authorized by section 447B of the PHS Act, as
amended by section 901 of Public Law 106-505 (42 U.S.C. 285f-3);
(23) Research relating to medical rehabilitation, as authorized by
section 452 of the PHS Act (42 U.S.C. 285g-4);
(24) Research on clinical and health services on eye care and
diabetes, as authorized by section 456 of the PHS Act (42 U.S.C. 285i-
1);
(25) Research on multiple sclerosis, especially research on the
effects of genetics and hormonal changes on the progress of the
disease, as authorized by section 460 of the PHS Act (42 U.S.C. 285j-
3);
(26) Research on the social, behavioral, and biomedical etiology,
the mental and physical health consequences, and the social and
economic consequences of alcohol abuse and alcoholism, as authorized by
464H of the PHS Act (42 U.S.C. 285n);
(27) Health services research activities with respect to the
prevention of alcohol abuse and treatment of alcoholism, as authorized
by section 464H of the PHS Act (42 U.S.C. 285n) and as defined in
section 409 of the PHS Act (42 U.S.C. 284d);
(28) Research under the Medication Development Program to encourage
and promote the development and use of medications to treat drug
addiction; and to collect, analyze, and disseminate data, as authorized
by section 464P of the PHS Act (42 U.S.C. 285o-4);
(29) Research on health-related educational technologies, on
medical library science and related activities, and for the development
or dissemination of new knowledge, techniques, systems, and equipment
for processing, storing, retrieving, and distributing information
pertaining to health sciences, as authorized by section 473 of the PHS
Act (42 U.S.C. 286b-4);
(30) Research with respect to identifying, investigating, and
validating complementary and alternative treatment, diagnostic and
prevention modalities, disciplines and systems of complementary and
alternative medicine, as authorized by section 485D (a) and (f) of the
PHS Act, as amended (42 U.S.C. 287c-21(a), (f));
(31) Research in the biomedical, contraceptive, development,
behavioral and program implementation fields related to family planning
and population, as authorized by section 1004 of the PHS Act (42 U.S.C.
300a-2);
(32) Basic and applied research regarding traumatic brain injury,
including the development, modification, and evaluation of therapies
and programs of rehabilitation toward reaching or restoring normal
capabilities, as authorized by section 1261 of the PHS Act, as amended
by section 1301 of Public Law 106-310 (42 U.S.C. 300d-61);
(33) Research on the causes, consequences, and approaches of coping
with adolescent sexual relations, contraceptive use, pregnancy, and
parenthood, as authorized by section 2008 of the PHS Act (42 U.S.C.
300z-7);
(34) Research relating to the evaluation of drug treatments for
AIDS not approved by the Commissioner of Food and Drugs, as authorized
by section 2314 of the PHS Act (42 U.S.C. 300cc-14);
(35) International research relating to the development and
evaluation of vaccines and treatments for AIDS, as authorized by
section 2315 of the PHS Act (42 U.S.C. 300cc-15);
(36) Long-term research into treatments for AIDS, as authorized by
section 2320 of the PHS Act (42 U.S.C. 300cc-20);
(37) Research relating to AIDS conducted outside the United States
by qualified foreign professionals and collaborative research involving
American and foreign participants, as authorized by section 2354 of the
PHS Act (42 U.S.C. 300cc-41);
(38) Basic research to identify, characterize, and quantify risks
to human health from air pollutants, as authorized by section 103 of
the Clean Air Act, as amended (42 U.S.C. 7403);
(39) Electronic product radiation control research programs
designed to protect the public health and safety from electronic
product radiation, as authorized by section 532 of the Federal Food,
Drug, and Cosmetic Act, as amended (21 U.S.C. 360ii);
(40) Research into areas where a microgravity environment may
contribute to significant progress in the understanding and treatment
of diseases and other medical conditions, as authorized by section 603
of the National Aeronautics and Space Administration Authorization Act,
Fiscal Year 1993 (42 U.S.C. 2487b);
(41) Support for radiation studies and research, as authorized
under section 301 of the PHS Act (42 U.S.C. 241) and by section 20(a)
of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a));
(42) Research on occupational safety and health problems in
industry, as authorized by section 20(a) of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 669(a)) and section 501 of the Federal
Coal Mine Health and Safety Act of 1969 (30 U.S.C. 951); and
(43) Research to stimulate health-related technological innovation
especially through the use of small business, minority, and
disadvantaged firms and increased private sector commercialization of
innovations derived from Federal research and development, as
authorized under section 301 of the PHS Act (42 U.S.C. 241), in
accordance with the procedures prescribed pursuant to section 2[9] of
the Small Business Innovation Development Act of 1982, as amended (15
U.S.C. 638).
The Catalog of Federal Domestic Assistance (CFDA) numbered
programs affected by title 42 of the Code of Federal regulations,
part 52, are:
93.113--Biological Response to Environmental Health Hazards
93.114--Applied Toxicological Research and Testing
93.115--Biometry and Risk Estimation--Health Risks from
Environmental Exposures
93.118--Acquired Immunodeficiency Syndrome (AIDS) Activity
93.121--Oral Diseases and Disorders Research
[[Page 56162]]
93.135--Centers for Research and Demonstration for Health Promotion
and Disease Prevention
93.136--Injury Prevention and Control Research and State and
Community Based Programs
93.172--Human Genome Research
93.173--Research Related to Deafness and Communication Disorders
93.184--Disabilities Prevention
93.213--Research and Training in Complementary and Alternative
Medicine
93.242--Mental Health Research Grants
93.262--Occupational Safety and Health Program
93.271--Alcohol Research Career Development Awards for Scientists
and Clinicians
93.273--Alcohol Research Programs
93.279--Drug Abuse and Addiction Research Programs
93.281--Mental Health Research Career/Scientist Development Awards
93.283--Centers for Disease Control and Prevention--Investigations
and Technical Assistance
93.361--Nursing Research
93.389--National Center for Research Resources
93.390--Academic Research Enhancement Award
93.393--Cancer Cause and Prevention Research
93.394--Cancer Detection and Diagnosis Research
93.395--Cancer Treatment Research
93.396--Cancer Biology Research
93.821--Biophysics and Physiological Sciences Research
93.837--Heart and Vascular Diseases Research
93.838--Lung Diseases Research
93.839--Blood Diseases and Resources Research
93.846--Arthritis, Musculoskeletal and Skin Diseases Research
93.847--Diabetes, Endocrinology and Metabolic Research
93.848--Digestive Diseases and Nutrition Research
93.849--Kidney Diseases, Urology and Hematology Research
93.853--Clinical Research Related to Neurological Disorders
93.855--Allergy, Immunology, and Transplantation Research
93.856--Microbiology and Infectious Diseases Research
93.859--Biomedical Research and Research Training
93.865--Child Health and Human Development Extramural Research
93.866--Aging Research
93.867--Vision Research
93.879--Medical Library Assistance
93.941--HIV Demonstration, Research, Public and Professional
Education Projects
93.942--Research, Treatment and Education Programs on Lyme Disease
in the United States
93.943--Epidemiologic Research Studies of Acquired Immunodeficiency
Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in
Selected Population Groups
93.947--Tuberculosis Demonstration, Research, Public and
Professional Education
Dated: September 19, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
Approved: September 19, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. E6-15729 Filed 9-25-06; 8:45 am]
BILLING CODE 4140-01-P
