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
Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 53973 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/AnimalVeterinary/ 

default.htm or http:// 

www.regulations.gov. 

Dated: August 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21981 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–0432] 

Guidance for Industry; Small Entities 

Compliance Guide—Designation of 

New Animal Drugs for Minor Uses or 

Minor Species; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

#200 entitled ‘‘Small Entities 

Compliance Guide—Designation of New 

Animal Drugs for Minor Uses or Minor 

Species.’’ This small entities compliance 

guide (SECG) aids industry in 

complying with the requirements of the 

final rule that published in the Federal 

Register of July 26, 2007. The Minor Use 

and Minor Species Animal Health Act 

of 2004 (MUMS act) establishes new 

regulatory procedures that provide 

incentives intended to make more drugs 

legally available to veterinarians and 

animal owners for the treatment of 

minor animal species and uncommon 

diseases in major animal species. 

DATES: Submit either electronic or 

written comments on the SECG at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the SECG 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 SECG. 

Submit electronic comments on the 

SECG 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: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9090, 

Margaret.oeller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

an SECG #200 entitled ‘‘Small Entities 

Compliance Guide—Designation of New 

Animal Drugs for Minor Uses or Minor 

Species.’’ This SECG aids industry in 

complying with the requirements of the 

final rule published in the Federal 

Register of July 26, 2007 (72 FR 41010). 

FDA has prepared this SECG 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 573 of the 

MUMS act. In enacting MUMS, 

Congress 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). These 

regulations describe the procedures for 

designating a new animal drug as a 

minor use or minor species drug. Such 

designation establishes eligibility for the 

incentives provided by the MUMS act. 

II. Significance of Guidance 

FDA is issuing this SECG as a level 2 

guidance 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 SECG 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 573 of the MUMS act have been 

approved under OMB control no. 0910– 

0605. 

IV. Comments 

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. 

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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the SECG at either http:// 

www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: August 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21980 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–2009–D–0574] 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex 12 on 

Analytical Sieving General Chapter; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 12: Analytical 

Sieving General Chapter.’’ The guidance 

was prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance provides the results of the 

ICH Q4B evaluation of the Analytical 

Sieving General Chapter harmonized 

text from each of the three 

pharmacopoeias (United States, 

European, and Japanese) represented by 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1