Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 72827 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: ANA Consultant and Evaluator 

Qualifications Form. 

OMB No.: 0970–0265. 

Description: The ANA Consultant and 

Evaluator Qualifications Form is used to 

collect information from prospective 

proposal reviewers in compliance with 

42 USC Section 2991d–1. The form 

allows the Commissioner of ANA to 

select qualified people to review grant 

applications for Social and Economic 

Development Strategies (SEDS), Native 

Language Preservation and 

Maintenance, and Environmental 

Regulatory Enhancement. The panel 

review process is a legislative mandate 

in the ANA grant funding process. 

Respondents: Native Americans, 

Native Alaskans, Native Hawaiians and 

other Pacific Islanders. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden hours 

per response 

Total burden 

hours 

ANA Consultant and Evaluator Qualifications Form ....................................... 300 1 1 300 

Estimated Total Annual Burden 

Hours: 300 

Additional Information: 

Copies of the proposed collection may 

be obtained 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. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, 

Fax: 202–395–7285. 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: November 22, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–29779 Filed 11–24–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0180] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Adoption of Food and Drug 

Administration Food Code by Local, 

State and Tribal Governments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Adoption of FDA Food Code by Local, 

State and Tribal Governments’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793, Denver.Presley@FDA.HHS.GOV. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 24, 2010 (75 FR 

36097), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0448. The 

approval expires on October 31, 2013. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: November 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29688 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0598] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Type A Medicated Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the recordkeeping requirements for 

manufacturers of type A medicated 

articles. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 25, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 


srobinson on DSKHWCL6B1PROD with NOTICES
72828 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Current Good Manufacturing Practice 

Regulations for Type A Medicated 

Articles—21 CFR Part 226 (OMB 

Control Number 0910–0154)—Extension 

Under section 501 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 351), FDA has the 

statutory authority to issue current good 

manufacturing practice (cGMP) 

regulations for drugs, including type A 

medicated articles. A type A medicated 

article is a feed product containing a 

concentrated drug diluted with a feed 

carrier substance. A type A medicated 

article is intended solely for use in the 

manufacture of another type A 

medicated article or a type B or type C 

medicated feed. Medicated feeds are 

administered to animals for the 

prevention, cure, mitigation, or 

treatment of disease or for growth 

promotion and feed efficiency. 

Statutory requirements for cGMPs for 

type A medicated articles have been 

codified in part 226 (21 CFR part 226). 

Type A medicated articles which are not 

manufactured in accordance with these 

regulations are considered adulterated 

under section 501(a)(2)(B) of the FD&C 

Act. Under part 226, a manufacturer is 

required to establish, maintain, and 

retain records for type A medicated 

articles, including records to document 

procedures required under the 

manufacturing process to assure that 

proper quality control is maintained. 

Such records would, for example, 

contain information concerning receipt 

and inventory of drug components, 

batch production, laboratory assay 

results (i.e., batch and stability testing), 

and product distribution. 

This information is needed so that 

FDA can monitor drug usage and 

possible misformulation of type A 

medicated articles. The information 

could also prove useful to FDA in 

investigating product defects when a 

drug is recalled. In addition, FDA will 

use the cGMP criteria in part 226 to 

determine whether or not the systems 

used by manufacturers of type A 

medicated articles are adequate to 

assure that their medicated articles meet 

the requirements of the FD&C Act as to 

safety and also meet the article’s 

claimed identity, strength, quality, and 

purity, as required by section 

501(a)(2)(B) of the FD&C Act. 

The respondents for type A medicated 

articles are pharmaceutical firms that 

manufacture both human and veterinary 

drugs, those firms that produce only 

veterinary drugs, and commercial feed 

mills. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

No. of recordkeepers 

Annual 

frequency per 

recordkeeping 

Total 

annual 

records 

Hours per 

record Total hours 

21 CFR Section: 

226.42 ........................................................................... 115 260 29,900 .75 22,425 

226.58 ........................................................................... 115 260 29,900 1.75 52,325 

226.80 ........................................................................... 115 260 29,900 .75 22,425 

226.102 ......................................................................... 115 260 29,900 1.75 52,325 

226.110 ......................................................................... 115 260 29,900 .25 7,475 

226.115 ......................................................................... 115 10 1,150 .5 575 

........................ ........................ ........................ ........................ 157,550 

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


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 72829 

The estimate of the time required for 

record preparation and maintenance is 

based on Agency communications with 

industry. Other information needed to 

calculate the total burden hours (i.e., 

manufacturing sites, number of type A 

medicated articles being manufactured, 

etc.) are derived from Agency records 

and experience. 

Dated: November 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29687 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Los Alamos Historical Document 

Retrieval and Assessment (LAHDRA) 

Project 

The Centers for Disease Control and 

Prevention (CDC) and the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) announces the following 

meeting. 

Name: Public Meeting to release CDC’s 

recommendations to the Department of 

Energy resulting from the release of the Final 

Report of the Los Alamos Historical 

Document Retrieval and Assessment 

(LAHDRA)Project. 

Time and Date: 5 p.m.–7 p.m., (Mountain 

Time), Wednesday, December 8, 2010 and 5 

p.m.–7 p.m. Thursday, December 9, 2010. 

Place: December 8, 2010, Santa Claran 

Hotel & Casino in Espanola (25 miles north 

of Santa Fe on US 84/285), 460 Riverside 

Drive, Espanola, New Mexico 87532, 

telephone 877–505–4949. 

December 9, 2010, Tularosa Senior & 

Community Center in Tularosa (14 miles 

north of Alamogordo on US 70), 1050 

Bookout Rd., Tularosa, New Mexico 88352, 

telephone 575–585–4532. 

Status: Open to the public, limited only by 

the space available. The meeting room(s) 

accommodates approximately 100 people. 

Background: Under a Memorandum of 

Understanding (MOU) signed in December 

1990 with the Department of Energy (DOE) 

and replaced by MOUs signed in 1996 and 

2000, the Department of Health and Human 

Services (HHS) was given the responsibility 

and resources for conducting analytic 

epidemiologic investigations of residents of 

communities in the vicinity of DOE facilities, 

workers at DOE facilities, and other persons 

potentially exposed to radiation or to 

potential hazards from non-nuclear energy 

production use. HHS delegated program 

responsibility to CDC. 

In addition, a memo was signed in October 

1990 and renewed in November 1992, 1996, 

and in 2000, between the Agency for Toxic 

Substances and Disease Registry (ATSDR) 

and DOE. The MOU delineates the 

responsibilities and procedures for ATSDR’s 

public health activities at DOE sites required 

under sections 104, 105, 107, and 120 of the 

Comprehensive Environmental Response, 

Compensation, and Liability Act (CERCLA or 

a Superfund). These activities include health 

consultations and public health assessments 

at DOE sites listed on, or proposed for, the 

Superfund National Priorities List and at 

sites that are the subject of petitions from the 

public; and other health-related activities 

such as epidemiologic studies, health 

surveillance, exposure and disease registries, 

health education, substance-specific applied 

research, emergency response, and 

preparation of toxicological profiles. 

Purpose: This study group was charged 

with locating, evaluating, cataloguing, and 

copying documents that contain information 

about historical chemical or radionuclide 

releases from facilities at the Los Alamos 

National Laboratory and Trinity Site since its 

inception. The purpose of this meeting is to 

release the CDC’s recommendations to the 

Department of Energy as a result of the 

release of the Final Report (http:// 

www.Lahdra.org). 

Matters to Be Discussed: Agenda items for 

the December 8th meeting include a 

presentation from the National Center for 

Environmental Health (NCEH) and poster 

sessions on various report topics. There will 

be time for the public to ask questions. At the 

December 9th meeting, ChemRisk personnel 

will present on the Final Report’s Trinity Site 

chapter. All agenda items are subject to 

change as priorities dictate. 

Contact Person for Additional Information: 

Phillip R. Green, Public Health Advisor, 

Radiation Studies Branch, Division of 

Environmental Hazards and Health Effects, 

NCEH, CDC, 1600 Clifton Road, NE., 

(Mailstop F–58), Atlanta, Georgia 30333, 

telephone 770/488–3748, fax 770/488–1539, 

or e-mail address: prg1@cdc.gov. 

Dated: November 19, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–29778 Filed 11–24–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0402, FDA– 

2010–M–0361, and FDA–2010–M–0519] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the Agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 


srobinson on DSKHWCL6B1PROD with NOTICES