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. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Amendments/Resubmissions 356h 314 17 5,338 20 106,760 

TOTAL 341,697 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The 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). 3The 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. 4The 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). 5The 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). 6The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2). 

7The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3). 

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

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

601.91(b)(2)(iii) 1 1 1 1 1 

1There 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. 

[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. 

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: 

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. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 32791 

MATERNAL AND CHILD HEALTH BUREAU SELECTED GRANT PROGRAMS

[Extensions with funding] 

Grantee/organization name State 

FY 2009 

authorized 

funding level 

Revised 

project end 

date 

Raising Special Kids ....................................................................................................................... AZ ................ $95,700 31–May–11. 

Support for Families of Children w/Disabilities ............................................................................... CA ................ 95,700 31–May–11. 

Family Voices of District of Columbia, Inc. .................................................................................... DC ................ 95,700 31–May–11. 

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 & Education Foundation .................................................. HI ................. 95,700 31–May–11. 

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 Needs .................................................................................. MA ................ 95,700 31–May–11. 

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 Center ...................................................................................... NC ................ 95,700 31–May–11. 

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 New Jersey ..................................................................... NJ ................. 95,700 31–May–11. 

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 Center ......................................................................... PA ................ 95,700 31–May–11. 

Rhode Island Parent Information Network, Inc. ............................................................................. RI ................. 95,700 31–May–11. 

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 Association ...................................................................................... WI ................. 95,700 31–May–11. 

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. 

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 

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 http:// 

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 http:// 

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 

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 


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