Discretionary Grant Program, 32790-32791 [2010-13788]
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32790
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
Form FDA No.
Amendments/Resubmissions
No. of
Respondents
356h
Annual Frequency
per Response
314
Total Annual
Responses
17
Hours per
Response
5,338
Total Hours
20
TOTAL
106,760
341,697
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirements under §§ 610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65.
4 The reporting requirements under §§ 610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c),
640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under § 601.12(c).
6 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3).
2 The
Under table 2 of this document, the
estimated recordkeeping burden of 1
hour is based on previous estimates for
the recordkeeping requirements
associated with the AER (Adverse Event
Reports) system.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Respondents
21 CFR Section
601.91(b)(2)(iii)
1 There
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Intended Recipients of the Award:
The 30 incumbent grantees (see list
below).
Amount of the Non-Competitive
Supplemental Funding: $97,500 per
grantee.
Authority: Section 501(c)(1) of the
Social Security Act, as amended.
CFDA Number: 93.110.
Project Period: June 1, 2010 through
May 31, 2011 for a total of 12 months.
[FR Doc. 2010–13815 Filed 6–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Discretionary Grant Program
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Noncompetitive
Program Extension Supplemental
Awards.
erowe on DSK5CLS3C1PROD with NOTICES
Annual Frequency
per Response
SUMMARY: HRSA will be issuing noncompetitive supplemental funding
under the Maternal Child and Health
Bureau’s Family to Family Health
Information Centers Program. This will
provide feasible time for the Maternal
and Child Health Bureau (MCHB) to
align fiscal resources and programmatic
goals as outlined in changes that
emerged as a result of enactment of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148) with the least
disruption to the States, communities,
and constituencies that currently
receive assistance and services from
these grantees.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:10 Jun 08, 2010
Jkt 220001
Justification for the Exception to
Competition
The program provides grants to
family-run/staffed organizations to
ensure families of children with special
health care needs have access to
adequate information about health and
community resources to allow informed
decisions around their children’s health
care. Family to Family Health
Information Centers (F2F HICs) were
originally authorized under the Family
Opportunity Act as part of the Budget
Deficit Reduction Act of 2005; Pub. L.
109–171. Congress specified that there
be a family-run/staffed center in each
State and the District of Columbia by
June 2009. These centers, among other
tasks, were to assist families of children
with special health care needs to make
informed choices about health care in
order to promote good treatment
decisions, cost effectiveness and
improved health outcomes by providing
information and educational
opportunities for families, their health
professionals, schools, and other
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
appropriate entities. Awards were
staggered based upon available funding
with 30 grantees awarded in 2007 with
project periods ending May 31, 2010. As
the end of their project period quickly
approached and continued funding was
not provided in the President’s Budget
for fiscal year (FY) 2010, MCHB
prepared for closeout of the program.
Section 5507 of the Patient Protection
and Affordable Care Act (the Affordable
Care Act) extended the F2F HICs
through FY 2012. Therefore, the MCHB
will extend the project periods of the 30
aforementioned grants into FY 2011.
This will provide sufficient fiscal
resources to continue programmatic
activities as outlined in legislation with
the least disruption to the States,
communities, and the MCHB
constituencies that currently receive
assistance and services from these
grantees. The MCHB will also delay the
competition for these grants until FY
2011 to ensure continuity of funding for
all eligible entities, with no eligible
entity being adversely impacted by the
extension.
FOR FURTHER INFORMATION CONTACT:
LaQuanta Person, Project Officer,
Integrated Services Branch, Division of
Services for Children with Special
Health Needs, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18A–18, Rockville, MD
20857; 301.443.2370; lperson@hrsa.gov.
E:\FR\FM\09JNN1.SGM
09JNN1
32791
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices
MATERNAL AND CHILD HEALTH BUREAU SELECTED GRANT PROGRAMS
[Extensions with funding]
Grantee/organization name
State
Raising Special Kids .......................................................................................................................
Support for Families of Children w/Disabilities ...............................................................................
Family Voices of District of Columbia, Inc. ....................................................................................
Family Institute for Family Involvement ..........................................................................................
Parent to Parent of Georgia, Inc. ...................................................................................................
Hawaii Pediatric Association Research & Education Foundation ..................................................
The Arc of Illinois ............................................................................................................................
About Special Kids, Inc. .................................................................................................................
Bayou Land Families Helping Families ..........................................................................................
Federation for Children With Special Needs ..................................................................................
The Parent’s Place of MD ..............................................................................................................
Maine Parent Federation ................................................................................................................
Pacer Center Inc. ............................................................................................................................
University of Southern Mississippi ..................................................................................................
Exceptional Children’s Assistance Center ......................................................................................
Family Voices of North Dakota, Inc ................................................................................................
PTI Nebraska ..................................................................................................................................
Statewide Parent Advocacy Network of New Jersey .....................................................................
Parents Reaching Out To Help ......................................................................................................
Family TIES of Nevada, Inc ...........................................................................................................
Parent to Parent of NYS .................................................................................................................
Oregon Family Support Network ....................................................................................................
Parent Education & Advocacy Leadership Center .........................................................................
Rhode Island Parent Information Network, Inc. .............................................................................
South Dakota Parent Connection, Inc. ...........................................................................................
Tennessee Disability Coalition .......................................................................................................
Texas Parent to Parent ..................................................................................................................
Utah Parent Center .........................................................................................................................
Parent to Parent of Vermont ..........................................................................................................
The Arc Wisconsin Disability Association ......................................................................................
AZ ................
CA ................
DC ................
FL .................
GA ................
HI .................
IL ..................
IN .................
LA .................
MA ................
MD ...............
ME ................
MN ...............
MS ................
NC ................
ND ................
NE ................
NJ .................
NM ...............
NV ................
NY ................
OR ................
PA ................
RI .................
SD ................
TN ................
TX ................
UT ................
VT ................
WI .................
Dated: June 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–13788 Filed 6–8–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0277]
Draft Guidance for Industry:
Compliance With Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Draft Guidance for
Industry: Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents.’’ The
draft guidance is intended to help small
VerDate Mar<15>2010
15:10 Jun 08, 2010
Jkt 220001
entities comply with the final
regulations restricting the sale and
distribution of cigarettes and smokeless
tobacco in order to protect children and
adolescents.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 31, 2010.
ADDRESSES: The draft guidance for
industry entitled ‘‘Draft Guidance for
Industry: Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents’’ is
available on the Internet at https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm, or a paper
copy may be ordered free of charge by
calling 1–877–287–1373.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
FY 2009
authorized
funding level
$95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
95,700
Revised
project end
date
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
31–May–11.
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Kathleen K. Quinn, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 240–276–
1717, Kathleen.Quinn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Public Law 111–31; 123 Stat.
1776) was enacted on June 22, 2009,
amending the Federal Food, Drug, and
Cosmetic Act (FFDCA) and providing
FDA with the authority to regulate
tobacco products. Section 102 of the
Tobacco Control Act requires FDA to
publish final regulations regarding
cigarettes and smokeless tobacco which
are identical in their provisions to the
regulations promulgated by FDA in
1996 (1996 final regulations) on August
28, 1996 (61 FR 44396), with certain
specified exceptions. In the Federal
Register of March 19, 2010 (75 FR
13225), FDA published its final
regulations entitled ‘‘Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
E:\FR\FM\09JNN1.SGM
09JNN1
Agencies
[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32790-32791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Discretionary Grant Program
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of Noncompetitive Program Extension Supplemental Awards.
-----------------------------------------------------------------------
SUMMARY: HRSA will be issuing non-competitive supplemental funding
under the Maternal Child and Health Bureau's Family to Family Health
Information Centers Program. This will provide feasible time for the
Maternal and Child Health Bureau (MCHB) to align fiscal resources and
programmatic goals as outlined in changes that emerged as a result of
enactment of the Patient Protection and Affordable Care Act (Pub. L.
111-148) with the least disruption to the States, communities, and
constituencies that currently receive assistance and services from
these grantees.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award: The 30 incumbent grantees (see
list below).
Amount of the Non-Competitive Supplemental Funding: $97,500 per
grantee.
Authority: Section 501(c)(1) of the Social Security Act, as
amended.
CFDA Number: 93.110.
Project Period: June 1, 2010 through May 31, 2011 for a total of 12
months.
Justification for the Exception to Competition
The program provides grants to family-run/staffed organizations to
ensure families of children with special health care needs have access
to adequate information about health and community resources to allow
informed decisions around their children's health care. Family to
Family Health Information Centers (F2F HICs) were originally authorized
under the Family Opportunity Act as part of the Budget Deficit
Reduction Act of 2005; Pub. L. 109-171. Congress specified that there
be a family-run/staffed center in each State and the District of
Columbia by June 2009. These centers, among other tasks, were to assist
families of children with special health care needs to make informed
choices about health care in order to promote good treatment decisions,
cost effectiveness and improved health outcomes by providing
information and educational opportunities for families, their health
professionals, schools, and other appropriate entities. Awards were
staggered based upon available funding with 30 grantees awarded in 2007
with project periods ending May 31, 2010. As the end of their project
period quickly approached and continued funding was not provided in the
President's Budget for fiscal year (FY) 2010, MCHB prepared for
closeout of the program.
Section 5507 of the Patient Protection and Affordable Care Act (the
Affordable Care Act) extended the F2F HICs through FY 2012. Therefore,
the MCHB will extend the project periods of the 30 aforementioned
grants into FY 2011. This will provide sufficient fiscal resources to
continue programmatic activities as outlined in legislation with the
least disruption to the States, communities, and the MCHB
constituencies that currently receive assistance and services from
these grantees. The MCHB will also delay the competition for these
grants until FY 2011 to ensure continuity of funding for all eligible
entities, with no eligible entity being adversely impacted by the
extension.
FOR FURTHER INFORMATION CONTACT: LaQuanta Person, Project Officer,
Integrated Services Branch, Division of Services for Children with
Special Health Needs, Maternal and Child Health Bureau, Health
Resources and Services Administration, 5600 Fishers Lane, Room 18A-18,
Rockville, MD 20857; 301.443.2370; lperson@hrsa.gov.
[[Page 32791]]
Maternal and Child Health Bureau Selected Grant Programs
[Extensions with funding]
----------------------------------------------------------------------------------------------------------------
FY 2009
Grantee/organization name State authorized Revised project end date
funding level
----------------------------------------------------------------------------------------------------------------
Raising Special Kids................... AZ......................... $95,700 31-May-11.
Support for Families of Children w/ CA......................... 95,700 31-May-11.
Disabilities.
Family Voices of District of Columbia, DC......................... 95,700 31-May-11.
Inc..
Family Institute for Family Involvement FL......................... 95,700 31-May-11.
Parent to Parent of Georgia, Inc....... GA......................... 95,700 31-May-11.
Hawaii Pediatric Association Research & HI......................... 95,700 31-May-11.
Education Foundation.
The Arc of Illinois.................... IL......................... 95,700 31-May-11.
About Special Kids, Inc................ IN......................... 95,700 31-May-11.
Bayou Land Families Helping Families... LA......................... 95,700 31-May-11.
Federation for Children With Special MA......................... 95,700 31-May-11.
Needs.
The Parent's Place of MD............... MD......................... 95,700 31-May-11.
Maine Parent Federation................ ME......................... 95,700 31-May-11.
Pacer Center Inc....................... MN......................... 95,700 31-May-11.
University of Southern Mississippi..... MS......................... 95,700 31-May-11.
Exceptional Children's Assistance NC......................... 95,700 31-May-11.
Center.
Family Voices of North Dakota, Inc..... ND......................... 95,700 31-May-11.
PTI Nebraska........................... NE......................... 95,700 31-May-11.
Statewide Parent Advocacy Network of NJ......................... 95,700 31-May-11.
New Jersey.
Parents Reaching Out To Help........... NM......................... 95,700 31-May-11.
Family TIES of Nevada, Inc............. NV......................... 95,700 31-May-11.
Parent to Parent of NYS................ NY......................... 95,700 31-May-11.
Oregon Family Support Network.......... OR......................... 95,700 31-May-11.
Parent Education & Advocacy Leadership PA......................... 95,700 31-May-11.
Center.
Rhode Island Parent Information RI......................... 95,700 31-May-11.
Network, Inc..
South Dakota Parent Connection, Inc.... SD......................... 95,700 31-May-11.
Tennessee Disability Coalition......... TN......................... 95,700 31-May-11.
Texas Parent to Parent................. TX......................... 95,700 31-May-11.
Utah Parent Center..................... UT......................... 95,700 31-May-11.
Parent to Parent of Vermont............ VT......................... 95,700 31-May-11.
The Arc Wisconsin Disability WI......................... 95,700 31-May-11.
Association.
----------------------------------------------------------------------------------------------------------------
Dated: June 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-13788 Filed 6-8-10; 8:45 am]
BILLING CODE 4165-15-P