Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 53971 

Action Program Legal Services, Inc. 

(CAPLAW). 

CFDA Number: 93.710. 

Legislative Authority: The legislative 

authority for this grant is provided by 

the American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5). Additional legislative authority and 

requirements are provided in Sections 

674(b)(2)(A) and 678A of the 

Community Services Block Grant 

(CSBG) Act, as amended (42 U.S.C. 

9903(b)(2)(A) and 9913). 

Amount of Award: $219,445. 

Project Period: August 15, 2010 

through August 14, 2011. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Community Services (OCS) has awarded 

a single source expansion supplement to 

Community Action Program Legal 

Services, Inc. (CAPLAW), located in 

Boston, MA. The project is designed to 

support T/TA that strengthens the 

ability of the Community Action 

Network to comply with and carry out 

the programs funded by ARRA. The 

objectives of the project are to: (1) 

clarify CSBG policy issues, and (2) 

strengthen CSBG-eligible entity 

governance and accountability. It will 

do so by analyzing CSBG policy issues 

needing clarification, as identified by 

OCS; developing policy 

recommendations to address CSBG 

policy issues applicable to ARRA and 

‘‘regular’’ CSBG funds; and responding 

to the legal, financial, and management 

T/TA needs among the recipients of 

CSBG ARRA funds. The project 

resources developed by CAPLAW, Inc. 

will promote accountability and help 

CSBG-eligible entities and States 

enhance the overall administration of 

ARRA-funded programs. These 

resources include issue-specific T/TA 

and individualized financial 

consultation; online interactive 

tutorials; financial network conference 

calls; online governance and financial 

management toolkit(s); and T/TA on 

CSBG ARRA guidance via webinars and 

audio conferences. The T/TA CAPLAW, 

Inc. will provide under this award is 

particularly critical at this time due to 

the large temporary increase in CSBG 

funding to CSBG-eligible entities and 

the need to ensure adherence to high 

standards of accountability and tracking 

of the funds and results. The activities 

funded by this single source expansion 

supplement expand upon prior 

activities provided by CAPLAW under 

their cooperative agreement. A new 

grant award number will be issued to 

allow CAPLAW to track and report 

separately on expenditures from funds 

made available by ARRA. 

FOR FURTHER INFORMATION CONTACT: 

Danielle Williams, U.S. Department of 

Health and Human Services, Office of 

Community Services, Administration 

for Children and Families, 370 L’Enfant 

Promenade, SW., Washington, DC 

20047, Telephone: (202) 205–4717, Email: Danielle.Williams@acf.hhs.gov. 

Dated: August 26, 2010. 

Yolanda J. Butler, 

Acting Director, Office of Community 

Services. 

[FR Doc. 2010–21977 Filed 9–1–10; 8:45 am] 

BILLING CODE 4184–27–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0367] 

Guidance for Industry and Food and 

Drug Administration Staff; ImpactResistant Lenses: Questions and 

Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Impact-Resistant Lenses: Questions and 

Answers.’’ This guidance document 

answers manufacturer, importer, and 

consumer questions on impact-resistant 

lenses, including questions on test 

procedures, lens testing apparatus, 

record maintenance, and exemptions to 

testing. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Impact-Resistant Lenses: 

Questions and Answers’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66. rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

guidance 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: John 

Stigi, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4622, Silver Spring, 

MD 20993–0002, 301–796–5848. 

SUPPLEMENTARY INFORMATION: 

I. Background 

To reduce the number of eye injuries, 

eyeglasses and sunglasses must be fitted 

with impact-resistant lenses capable of 

withstanding the impact test described 

under 21 CFR 801.410(d)(2). This 

guidance answers questions for 

manufacturers, importers, and testing 

laboratories on such topics as test 

procedures, lens testing apparatus, 

record maintenance, and exemptions to 

testing. This document also contains 

more detailed and updated discussions 

of (1) lens blanks, (2) semi-finished, 

finished, and plano lenses, and (3) 

import entry inspections. 

The draft version of this document 

was announced in the Federal Register 

of October 26, 2007 (72 FR 60862). 

Interested persons were invited to 

comment by January 24, 2008. FDA 

received numerous comments from 

laboratories, trade associations, retail 

establishments, and consumers 

surrounding three main issues. FDA 

further clarified the definition of 

‘‘manufacturer’’ according to the Quality 

System regulation (21 CFR 820.3(o)). 

Additionally, based on data provided in 

the comments, FDA eliminated a 

question regarding the salability of 

plastic prescription lenses tested as part 

of a statistical sample. FDA also 

modified several questions which had 

indicated that the testing of all lenses 

had to be done after edging to clarify 

that all plastic prescription lenses and 

glass over-the-counter lenses could be 

tested in either ‘‘un-cut finished’’ or 

‘‘finished’’ form. 

This guidance supersedes ‘‘ImpactResistant Lenses: Questions and 

Answers’’ (FDA 87–4002), issued 

September 1987. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on impact-resistant 

lenses. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
53972 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Impact-Resistant 

Lenses: Questions and Answers,’’ you 

may either send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number (23) to identify the guidance 

you are requesting. A search capability 

for all CDRH guidance documents is 

available at http://www.fda.gov/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

default.htm. Guidance documents are 

also available at http:// 

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR 801.109 have been approved 

under OMB Control No. 0910–0485; the 

collections of information in 21 CFR 

807.87 have been approved under OMB 

Control No. 0910–0120; and the 

collections of information in 21 CFR 

Part 820 have been approved under 

OMB Control No. 0910–0073. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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: August 27, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–21908 Filed 9–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0435] 

Guidance for Industry; Small Entities 

Compliance Guide—The Index of 

Legally Marketed Unapproved New 

Animal Drugs for Minor Species; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a Level 2 guidance for 

industry #201 entitled ‘‘Small Entities 

Compliance Guide—The Index of 

Legally Marketed Unapproved New 

Animal Drugs for Minor Species.’’ This 

small entities compliance guide aids 

industry in complying with the 

requirements of the final rule that 

published in the Federal Register of 

December 6, 2007. This regulation 

establishes administrative procedures 

and criteria for index listing a new 

animal drug for use in a minor species 

as provided by the Minor Use and 

Minor Species Animal Health Act of 

2004 (MUMS). 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance 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. 

FOR FURTHER INFORMATION CONTACT: Joan 

Gotthardt, Center for Veterinary 

Medicine (HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

MPN2, rm. N371, Rockville, MD 20855, 

240–276–9090, email: 

Joan.gotthardt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a Level 2 guidance for industry #201 

entitled ‘‘Small Entities Compliance 

Guide—The Index of Legally Marketed 

Unapproved New Animal Drugs for 

Minor Species.’’ This guidance aids 

industry in complying with the 

requirements of the final rule published 

in the Federal Register of December 6, 

2007 (72 FR 69108) (the indexing 

regulation). 

FDA has prepared this guidance in 

accordance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121). This 

document is intended to provide 

guidance to small businesses on the 

requirements of section 572 of the 

MUMS act. Congress, in enacting 

MUMS, sought to encourage the 

development of animal drugs that are 

currently unavailable to minor species 

(species other than cattle, horses, swine, 

chickens, turkeys, dogs, and cats) in the 

United States or to major species 

afflicted with uncommon diseases or 

conditions (minor uses). The indexing 

regulation establishes procedures and 

criteria for index listing a new animal 

drug for use in a minor species. 

II. Significance of Guidance 

This level 2 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

section 572 of the MUMS act have been 

approved under OMB Control No. 0910– 

0620. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1