Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 10605 

prior to each public meeting in order to 

bring pieces of equipment or medical 

devices. These arrangements need to be 

made with the public meeting 

coordinator. It is possible that certain 

requests made in advance of the public 

meeting could be denied because of 

unique safety, security or handling 

issues related to the equipment. A 

minimum of 2 weeks is required for 

approvals and security procedures. Any 

request not submitted at least 2 weeks 

in advance of the public meeting will be 

denied. 

CMS policy requires that every 

foreign visitor is assigned a host. The 

host/hosting official is required to 

inform the Division of Critical 

Infrastructure Protection (DCIP) at least 

12 business days in advance of any visit 

by a foreign national visitor. Foreign 

National visitors will be required to 

produce a valid passport at the time of 

entry. 

Attendees that are Foreign Nationals 

need to identify themselves as such, and 

provide the following information for 

security clearance to the public meeting 

coordinator by the date specified in the 

DATES section of this notice: 

• Visitor’s full name (as it appears on 

passport). 

• Gender. 

• Country of origin and citizenship. 

• Biographical data and related 

information. 

• Date of birth. 

• Place of birth. 

• Passport number. 

• Passport issue date. 

• Passport expiration date. 

• Dates of visits. 

• Company Name. 

• Position/Title. 

Authority: Section 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 42 

U.S.C. 1395hh). 

Dated: February 10, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–3812 Filed 2–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Refugee Assistance Program 

Estimates: CMA—ORR–1. 

OMB No.: 0970–0030. 

Description: 

The Refugee Assistance Program 

Estimates: ORR–1 form is the 

application for funding for the Refugee 

Cash and Medical Assistance program. 

Applicants for funding provide 

estimates of costs of the different 

components of the program—Refugee 

Cash Assistance, Refugee Medical 

Assistance, Health Screening, Services 

to Unaccompanied Refugee Minors, 

Administrative Cost of the Services to 

Unaccompanied Refugee Minors 

program, and Administrative Costs of 

the State Refugee Coordinator. 

Applicants also submit a narrative 

justification for their estimates. 

Applicants submit the form annually on 

August 15 of the fiscal year prior to the 

fiscal year for which funds are being 

requested. The form may be submitted 

through an On-Line Data Collection 

system or hard copy format. The Office 

of Refugee Resettlement uses the cost 

estimate data from the ORR–1 in 

determining and allocating quarterly 

awards of funds and in projecting full 

year costs of this program. 

Respondents: 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Refugee Assistance Program Estimates: ORR–1 ........................................... 46 1 2 92 

Estimated Total Annual Burden Hours: ........................................................... ........................ ........................ ........................ 92 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: February 22, 2011. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–4278 Filed 2–24–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0597] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Index of Legally 

Marketed Unapproved New Animal 

Drugs for 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. 


srobinson on DSKHWCL6B1PROD with NOTICES
10606 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 

DATES: Fax written comments on the 

collection of information by March 28, 

2011. 

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 0910–0620. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, Juanmanuel.vilela@fda.hhs.gov. 

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. 

Index of Legally Marketed Unapproved 

New Animal Drugs for Minor Species— 

21 CFR Part 516 (OMB Control Number 

0910–0620)—Extension 

The Minor Use and Minor Species 

Animal Health Act of 2004 (MUMS Act) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C 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 

(species other than cattle, horses, swine, 

chickens, turkeys, dogs, and cats), as 

well as uncommon diseases in major 

animal species. 

The MUMS Act created three new 

sections in the FD&C Act (sections 571, 

572, and 573 (21 U.S.C. 360ccc, 360ccc– 

1, and 360ccc–2)). The final rule (72 FR 

69108, December 6, 2007) (the 

December 2007 final rule) implements 

section 572 of the FD&C Act that 

provides for an index of legally 

marketed unapproved new animal drugs 

for minor species. Participation in any 

part of the MUMS program is optional 

so the associated paperwork only 

applies to those who choose to 

participate. The December 2007 final 

rule specifies, among other things, the 

criteria and procedures for requesting 

eligibility for indexing and for 

requesting addition to the index as well 

as the annual reporting requirements for 

index holders. 

Under the new subpart C of part 516 

(21 CFR part 516), § 516.119 provides 

requirements for naming a permanentresident U.S. agent by foreign drug 

companies, and § 516.121 provides for 

informational meetings with FDA. 

Section 516.123 provides requirements 

for requesting informal conferences 

regarding Agency administrative actions 

and § 516.125 provides for 

investigational use of new animal drugs 

intended for indexing. Provisions for 

requesting a determination of eligibility 

for indexing can be found under 

§ 516.129 and provisions for subsequent 

requests for addition to the index can be 

found under § 516.145. A description of 

the written report required in § 516.145 

can be found under § 516.143. Under 

§ 516.141 are provisions for drug 

companies to nominate a qualified 

expert panel as well as the panel’s 

recordkeeping requirements. Section 

516.141 also calls for the submission of 

a written conflict of interest statement to 

FDA by each proposed panel member. 

Index holders are able to modify their 

index listing under § 516.161 or change 

drug ownership under § 516.163. 

Requirements for records and reports 

are under § 516.165. 

In the Federal Register of December 3, 

2010 (75 FR 75481), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received no 

comments. 

Description of Respondents: 

Pharmaceutical companies that sponsor 

new animal drugs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

516.119 ................................................................................ 2 1 2 1 2 

516.121 ................................................................................ 30 2 60 4 240 

516.123 ................................................................................ 3 1 3 8 24 

516.125 ................................................................................ 2 3 6 20 120 

516.129 ................................................................................ 30 2 60 20 1,200 

516.141 ................................................................................ 20 1 20 16 320 

516.143 ................................................................................ 20 1 20 120 2,400 

516.145 ................................................................................ 20 1 20 20 400 

516.161 ................................................................................ 1 1 1 4 4 

516.163 ................................................................................ 1 1 1 2 2 

516.165 ................................................................................ 10 2 20 8 160 

Total .............................................................................. 4,872 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section No. of recordkeepers 

Annual 

frequency per 

recordkeeper 

Total annual 

records 

Hours per 

recordkeeper Total hours 

516.141 ................................................................................ 30 2 60 0.5 30 

516.165 ................................................................................ 10 2 20 1 20 

Total .............................................................................. 50 

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


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 10607 

Dated: February 18, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4219 Filed 2–24–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary 

Cosmetic Registration Program 

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 March 28, 

2011. 

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 0910–0027. 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. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

(OMB Control Number 0910–0027)— 

Revision 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides FDA with 

the authority to regulate cosmetic 

products in the United States. Cosmetic 

products that are adulterated under 

section 601 of the FD&C Act (21 U.S.C. 

361) or misbranded under section 602 of 

the FD&C Act (21 U.S.C. 362) may not 

be distributed in interstate commerce. 

To assist FDA in carrying out its 

responsibility to regulate cosmetics, the 

Agency has developed the Voluntary 

Cosmetic Registration Program (VCRP). 

In 21 CFR part 710, FDA requests that 

establishments that manufacture or 

package cosmetic products register with 

the Agency on Form FDA 2511 entitled 

‘‘Registration of Cosmetic Product 

Establishment.’’ The term ‘‘Form FDA 

2511’’ refers to both the paper and 

electronic versions of the form. The 

electronic version of Form FDA 2511 is 

available on FDA’s VCRP Web site at 

http://www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/

VoluntaryCosmeticsRegistration

ProgramVCRP/OnlineRegistration/

default.htm. FDA’s online registration 

system, intended to make it easier to 

participate in the VCRP, was made 

available industrywide on December 1, 

2005. The Agency strongly encourages 

electronic registration of Form FDA 

2511 because it is faster and more 

convenient. A registering facility will 

receive confirmation of electronic 

registration, including a registration 

number, by e-mail, usually within 7 

business days. The online system also 

allows for amendments to past 

submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. FDA 

places the registration information in a 

computer database and uses the 

information to generate mailing lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. FDA also uses the 

information for estimating the size of 

the cosmetic industry and for 

conducting onsite establishment 

inspections. Registration is permanent, 

although FDA requests that respondents 

submit an amended Form FDA 2511 if 

any of the originally submitted 

information changes. 

In part 720 (21 CFR part 720), FDA 

requests that firms that manufacture, 

pack, or distribute cosmetics file with 

the Agency an ingredient statement for 

each of their products. Ingredient 

statements for new submissions 

(§§ 720.1 through 720.4) are reported on 

Form FDA 2512, ‘‘Cosmetic Product 

Ingredient Statement,’’ and on Form 

FDA 2512a, a continuation form. 

Amendments to product formulations 

(§ 720.6) also are reported on Forms 

FDA 2512 and FDA 2512a. When a firm 

discontinues the commercial 

distribution of a cosmetic, FDA requests 

that the firm file Form FDA 2514, 

‘‘Notice of Discontinuance of 

Commercial Distribution of Cosmetic 

Product Formulation’’ (§§ 720.3 and 

720.6). If any of the information 

submitted on or with these forms is 

confidential, the firm may submit a 

request for confidentiality under 

§ 720.8. 

FDA’s online filing system is available 

on FDA’s VCRP Web site at http:// 

www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/

VoluntaryCosmeticsRegistration

ProgramVCRP/OnlineRegistration/ 

default.htm. The online filing system 

contains the electronic versions of 

Forms FDA 2512, 2512a, and 2514, 

which are collectively found within the 

electronic version of Form FDA 2512. 

The Agency strongly encourages 

electronic filing of Form FDA 2512 

because it is faster and more convenient. 

A filer will receive confirmation of 

electronic filing by e-mail. 

FDA places cosmetic product filing 

information in a computer database and 

uses the information for evaluation of 

cosmetic products currently on the 

market. Because filing of cosmetic 

product formulations is not mandatory, 

voluntary filings provide FDA with the 

best information available about 

cosmetic product ingredients and their 

frequency of use, businesses engaged in 

the manufacture and distribution of 

cosmetics, and approximate rates of 

product discontinuance and formula 

modifications. The information assists 

FDA scientists in evaluating reports of 

alleged injuries and adverse reactions 

from the use of cosmetics. The 

information also is used in defining and 

planning analytical and toxicological 

studies pertaining to cosmetics. 

Information from the database is 

releasable to the public under FDA 

compliance with the Freedom of 

Information Act. FDA shares 

nonconfidential information from its 

files on cosmetics with consumers, 

medical professionals, and industry. 

In the Federal Register of December 

15, 2010 (75 FR 78257), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one letter, 

containing multiple comments in 

response to the notice. 

(Comment 1) One comment was 

generally supportive of the necessity of 

the information collection and its 

practical utility. 


srobinson on DSKHWCL6B1PROD with NOTICES