Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 19669 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Total .......................................................................................................... 192 na na 58 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Demographic Questionnaire ............................................................................ 48 4 $21.35 $85 

S-TOFHLA Questionnaire ................................................................................ 48 6 21.35 128 

Health Education Materials & Interview—English, Inhaler .............................. 24 12 21.35 256 

Health Education Materials & Interview —English & Spanish, Colonoscopy 48 24 21.35 512 

Health Education Materials & Interview—Spanish, High Blood Pressure ...... 24 12 21.35 256 

Total .......................................................................................................... 192 58 na 1,237 

* Based upon the mean wage for all occupations, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. 

Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

The total cost of this contract to the 

government is $524,945, and the project 

extends over 3 years (July 19, 2010 to 

July 18, 2013). The data collection for 

which we are seeking OMB clearance 

will take place from September 1, 2012 

to December 31, 2012. Exhibit 3 shows 

a breakdown of the total cost as well as 

the annualized cost for the data 

collection, processing and analysis 

activity for this entire contract. 

EXHIBIT 3—ESTIMATED COST

Cost Component Total Cost Annual Cost 

Project Development ....................................................................................................................................... $66,447 $22,149 

Data Collection Activities ................................................................................................................................. 129,547 43,182 

Data Processing and Analysis ......................................................................................................................... 129,548 43,183 

Publication of Results ...................................................................................................................................... 131,571 43,857 

Project Management ........................................................................................................................................ 67,832 22,611 

Total .......................................................................................................................................................... 524,945 174,982 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: March 22, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–7768 Filed 3–30–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for 

Scientific Review Special Emphasis 

Panel; Neurodegeneration: Mechanisms 

and Therapeutic Targets. 

Date: April 17, 2012. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Laurent Taupenot, 

Ph.D, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

4811, MSC 7850, Bethesda, MD 20892, 

301–435–1203, taupenol@csr.nih.gov. 

Name of Committee: Center for 

Scientific Review Special Emphasis 

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19670 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 

Panel; Member conflict: Chemosensory, 

Pain and Hearing. 

Date: April 18–19, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: John Bishop, Ph.D, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

5182, MSC 7844, Bethesda, MD 20892, 

(301) 408–9664, bishopj@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 27, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7821 Filed 3–30–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0294] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Contact 

Substance Notification Program 

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 collection of information associated 

with the Food Contact Substance 

Notification Program, including 

revisions to Form FDA 3480, new Form 

FDA 3480A, and electronic submission 

via the Electronic Submission Gateway 

(ESG). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 29, 2012. 

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 

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:

With regard to the information 

collection: Denver Presley, Jr., Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3793. 

With regard to the Food Contact 

Substance Notification Program: 

Kenneth A. McAdams, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy (HFS–275), College Park, MD 

20740, 240–402–1224, Fax: 301–436– 

2965, email: 

Kenneth.mcadams@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. 

Food Contact Substance Notification 

Program—21 CFR 170.101, 170.106, 

and 171.1 (OMB Control Number 0910– 

0495)—Revision 

Section 409(h) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 348(h)) establishes a 

premarket notification process for food 

contact substances. Section 409(h)(6) of 

the FD&C Act defines a ‘‘food contact 

substance’’ as ‘‘any substance intended 

for use as a component of materials used 

in manufacturing, packing, packaging, 

transporting, or holding food if such use 

is not intended to have any technical 

effect in such food.’’ Section 409(h)(3) of 

the FD&C Act requires that the 

notification process be used for 

authorizing the marketing of food 

contact substances except when: (1) 

FDA determines that the submission 

and premarket review of a food additive 

petition (FAP) under section 409(b) of 

the FD&C Act is necessary to provide 

adequate assurance of safety or (2) FDA 

and the manufacturer or supplier agree 

that an FAP should be submitted. 

Section 409(h)(1) of the FD&C Act 

requires that a notification include: (1) 

Information on the identity and the 

intended use of the food contact 

substance and (2) the basis for the 

manufacturer’s or supplier’s 

determination that the food contact 

substance is safe under the intended 

conditions of use. 

Sections 170.101 and 170.106 (21 CFR 

170.101 and 170.106) specify the 

information that a notification must 

contain and require that: (1) A food 

contact substance notification (FCN) 

include a completed and signed Form 

FDA 3480 and (2) a notification for a 

food contact substance formulation 

include a completed and signed Form 

FDA 3479. These forms serve to 

summarize pertinent information in the 

notification. The forms facilitate both 

preparation and review of notifications 

because the forms serve to organize 

information necessary to support the 

safety of the use of the food contact 

substance. The burden of filling out the 

appropriate form has been included in 

the burden estimate for the notification. 

Currently, interested persons transmit 

an FCN submission to the Office of Food 

Additive Safety in the Center for Food 

Safety and Applied Nutrition using 

Form FDA 3480 whether it is submitted 

in electronic or paper format. FDA 

recently made minor revisions to Form 

FDA 3480 to better enable its use for 

electronic submission and to prompt 

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