Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59721 

Instrument Number of 

respondents 

Responses/ 

respondents 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Employment Verification Form ............................................. 8,000 1 8,000 .50 4,000 

Authorization for Release of Employment Information 

Form ................................................................................. 8,000 1 8,000 .10 800 

Authorization to Release Information Form ......................... 8,000 1 8,000 .10 800 

Certification Regarding Debarment, Suspension, Disqualification and Related Matters Form ................................... 8,000 1 8,000 .10 800 

Certification of Accreditation Status for School of Nursing 

Education Programs Form ............................................... 500 1 500 .10 50 

Application Checklist and Self-Certification Form ............... 8,000 1 8,000 .50 4,000 

Total .............................................................................. ........................ ........................ 72,500 ........................ 46,450 

The annual estimate of burden for 

Participants is as follows: 

Participant Semi-Annual Employment Verification Form ..... 2,300 2 4,600 .5 2,300 

Total .............................................................................. 2,300 2 4,600 .5 2,300 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: September 22, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–24209 Filed 9–27–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0356] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Designated New 

Animal Drugs for Minor Use and Minor 

Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 28, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0605. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Designated New Animal Drugs for 

Minor Use and Minor Species; (OMB 

Control Number 0910–0605)—Extension 

The Minor Use and Minor Species 

(MUMS) Animal Health Act of 2004 

amended the Federal Food, Drug, and 

Cosmetic Act to authorize FDA to 

establish new regulatory procedures 

intended to make more medications 

legally available to veterinarians and 

animal owners for the treatment of 

minor animal species as well as 

uncommon diseases in major animal 

species. This legislation provides 

incentives designed to help 

pharmaceutical companies overcome 

the financial burdens they face in 

providing limited-demand animal 

drugs. These incentives are only 

available to sponsors whose drugs are 

‘‘MUMS-designated’’ by FDA. Minor use 

drugs are drugs for use in major species 

(cattle, horses, swine, chickens, turkeys, 

dogs, and cats) that are needed for 

diseases that occur in only a small 

number of animals either because they 

occur infrequently or in limited 

geographic areas. Minor species are all 

animals other than the major species, for 

example, zoo animals, ornamental fish, 

parrots, ferrets, and guinea pigs. Some 

animals of agricultural importance are 

also minor species. These include 

animals such as sheep, goats, catfish, 

and honeybees. Participation in the 

MUMS program is completely optional 

for drug sponsors so the associated 

paperwork only applies to those 

sponsors who request and are 

subsequently granted ‘‘MUMS 

designation.’’ The rule specifies the 

criteria and procedures for requesting 

MUMS designation as well as the 

annual reporting requirements for 

MUMS designees. 

Under part 516 ( 21 CFR part 516), 

§ 516.20 provides requirements on the 

content and format of a request for 

MUMS-drug designation, § 516.26 

provides requirements for amending 

MUMS-drug designation, § 516.27 

provides provisions for change in 

sponsorship of MUMS-drug designation, 

§ 516.29 provides provisions for 

termination of MUMS-drug designation, 

§ 516.30 provides requirements for 

annual reports from sponsor(s) of 

MUMS-designated drugs, and § 516.36 

provides provisions for insufficient 

quantities of MUMS-designated drugs. 

Respondents are pharmaceutical 

companies that sponsor new animal 

drugs. 

In the Federal Register of July 20, 

2010 (75 FR 42094), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. In response, FDA received 


srobinson on DSKHWCL6B1PROD with NOTICES
59722 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

one comment that was not responsive to 

the comment request on the information 

collection provision. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

516.20 15 5 75 16 1,200 

516.26 3 1 3 2 6 

516.27 1 1 1 1 1 

516.29 2 1 2 1 2 

516.30 15 5 75 2 150 

516.36 1 1 1 3 3 

Total 1,362 

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

The burden estimate for this reporting 

requirement was derived in our Office 

of Minor Use and Minor Species Animal 

Drug Development by extrapolating the 

current investigational new animal drug 

(INAD)/new animal drug application 

(NADA) reporting requirements for 

similar actions by this same segment of 

the regulated industry and from 

previous interactions with the minor 

use/minor species community. 

Dated: September 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24273 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0373] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Preparing a Claim 

of Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 28, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0541. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Preparing a Claim of Categorical 

Exclusion or an Environmental 

Assessment for Submission to the 

Center for Food Safety and Applied 

Nutrition (OMB Control Number 0910– 

0541)—Extension 

As an integral part of its 

decisionmaking process, FDA is 

obligated under the National 

Environmental Policy Act of 1969 

(NEPA) to consider the environmental 

impact of its actions, including allowing 

notifications for food contact substances 

to become effective and approving food 

additive petitions, color additive 

petitions and GRAS petition requests for 

exemption from regulation as a food 

additive, and actions on certain food 

labeling citizen petitions, nutrient 

content claims petitions, and health 

claims petitions. In 1997, FDA amended 

its regulations in part 25 (21 CFR part 

25) to provide for categorical exclusions 

for additional classes of actions that do 

not individually or cumulatively have a 

significant effect on the human 

environment (62 FR 40570, July 29, 

1997). As a result of that rulemaking, 

FDA no longer routinely requires 

submission of information about the 

manufacturing and production of FDAregulated articles. FDA also has 

eliminated the previously required 

Environmental Assessment (EA) and 

abbreviated EA formats from the 

amended regulations. Instead, FDA has 

provided guidance that contains sample 

formats to help industry submit a claim 

of categorical exclusion or an EA to 

FDA’s Center for Food Safety and 

Applied Nutrition (CFSAN). The 

guidance document entitled ‘‘Preparing 

a Claim of Categorical Exclusion or an 

Environmental Assessment for 

Submission to the Center for Food 

Safety and Applied Nutrition’’ 

identifies, interprets, and clarifies 

existing requirements imposed by 

statute and regulation, consistent with 

the Council on Environmental Quality 

regulations (40 CFR 1507.3). It consists 

of recommendations that do not 

themselves create requirements; rather, 

they are explanatory guidance for FDA’s 

own procedures in order to ensure full 

compliance with the purposes and 

provisions of NEPA. 

The guidance provides information to 

assist in the preparation of claims of 

categorical exclusion and EAs for 

submission to CFSAN. The following 


srobinson on DSKHWCL6B1PROD with NOTICES