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
53974 Federal Register / Vol. 75, No. 170 / Thursday, September 2, 2010 / Notices 

the Pharmacopoeial Discussion Group 

(PDG). The guidance conveys 

recognition of the three pharmacopoeial 

methods by the three ICH regulatory 

regions and provides specific 

information regarding the recognition. 

The guidance is intended to recognize 

the interchangeability between the local 

regional pharmacopoeias, thus avoiding 

redundant testing in favor of a common 

testing strategy in each regulatory 

region. This guidance is in the form of 

an annex to the core guidance on the 

Q4B process entitled ‘‘Q4B Evaluation 

and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions’’ (the core ICH Q4B 

guidance). 

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 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. 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: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242, or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of December 

17, 2009 (74 FR 66982), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 12: Analytical 

Sieving General Chapter.’’ The notice 

gave interested persons an opportunity 

to submit comments by February 16, 

2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 12: Analytical 

Sieving General Chapter’’ was submitted 

to the ICH Steering Committee and 

endorsed by the three participating 

regulatory agencies in June 2010. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Analytical Sieving 

General Chapter harmonization 

proposal originating from the threeparty PDG. This guidance is in the form 

of an annex to the core ICH Q4B 

guidance made available in the Federal 

Register of February 21, 2008 (73 FR 

9575). When implemented, the annex 

will provide guidance for industry and 

regulators on the use of the specific 

pharmacopoeial texts evaluated by the 

ICH Q4B process. Following receipt of 

comments on the draft, no substantive 

changes were made to the annex. 

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 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. 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: August 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21979 Filed 9–1–10; 8:45 am] 

BILLING CODE 4160–01–S 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1