Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 2397 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

1.337, 1.345, and 1.352 (Records maintenance) ............ 379,493 1 379,493 13.228 5,020,000 

1.337, 1.345, and 1.352 (Learning for new firms) ........... 18,975 1 18,975 4.790 90,890 

Total .......................................................................... 5,110,890 

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

This estimate is based on FDA’s 

estimate of the number of facilities 

affected by the final rule entitled 

‘‘Establishment and Maintenance of 

Records Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002,’’ published in 

the Federal Register of December 9, 

2004 (69 FR 71562 at 71630). With 

regard to records maintenance, FDA 

estimates that approximately 379,493 

facilities will spend 13.228 hours 

collecting, recording, and checking for 

accuracy the limited amount of 

additional information required by the 

regulations, for a total of 5,020,000 

hours annually. In addition, FDA 

estimates that new firms entering the 

affected businesses will incur a burden 

from learning the regulatory 

requirements and understanding the 

records required for compliance. In this 

regard, the Agency estimates the 

number of new firms entering the 

affected businesses to be 5 percent (5%) 

of 379,493, or 18,975 firms. Thus, FDA 

estimates that approximately 18,975 

facilities will spend 4.790 hours 

learning about the recordkeeping and 

records access requirements, for a total 

of 90,890 hours annually. Therefore, the 

total annual recordkeeping burden is 

estimated to be 5,110,890 hours. 

Dated: January 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–592 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Menthol Report Subcommittee of the 

Tobacco Products Scientific Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Menthol Report 

Subcommittee of the Tobacco Products 

Scientific Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 11, 2011, from 9 a.m. 

to 5 p.m. 

Location: Center for Tobacco 

Products, 9200 Corporate Blvd, 

Rockville, MD, 20850. The telephone 

number is 1–877–287–1373. 

Contact Person: Caryn Cohen, Office 

of Science, Center for Tobacco Products, 

Food and Drug Administration, 9200 

Corporate Blvd, Rockville, MD 20850, 

1–877–287–1373 (choose Option 4), email: TPSAC@fda.hhs.gov or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On February 11, 2011, the 

subcommittee will receive presentations 

and discuss the timelines and structure 

of the Tobacco Products Scientific 

Advisory Committee’s required report to 

the Secretary of Health and Human 

Services regarding the impact of use of 

menthol in cigarettes on the public 

health. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 28, 2011. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 noon on February 11, 2011. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 20, 2011. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 21, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caryn Cohen 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 


srobinson on DSKHWCL6B1PROD with NOTICES
2398 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Notices 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 6, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–635 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Tobacco Products Scientific Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Tobacco 

Products Scientific Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 10, 2011, from 8 a.m. 

until 5 p.m. 

Location: Center for Tobacco 

Products, 9200 Corporate Blvd., 

Rockville, MD 20850. The phone 

number is 1–877–287–1373. 

Contact Person: Caryn Cohen, Office 

of Science, Center for Tobacco Products, 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

1–877–287–1373 (choose Option 4), email: TPSAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On February 10, 2011, the 

Committee will continue to do the 

following: (1) Receive updates from the 

Menthol Report Subcommittee and (2) 

receive and discuss presentations 

regarding the data requested by the 

Committee at the March 30 through 31, 

2010, meeting of the Tobacco Products 

Scientific Advisory Committee. 

FDA intends to make redacted 

background material available to the 

public no later than 2 business days 

before the meeting. If FDA is unable to 

post the background material on its Web 

site prior to the meeting, the background 

material will be made publicly available 

at the location of the advisory 

committee meeting, and the background 

material will be posted on FDA’s Web 

site after the meeting. Background 

material is available at http:// 

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

link. 

Procedure: On February 10, 2011, 

from 1 p.m. to 5 p.m., the meeting is 

open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 27, 2011. 

Oral presentations from the public will 

be scheduled between approximately 3 

p.m. and 4 p.m. on February 10, 2011. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 19, 2011. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 20, 2011. 

Closed Committee Deliberations: On 

January 10, 2011, from 9 a.m. to 12 

noon, the meeting will be closed to 

permit discussion and review of trade 

secret and/or confidential commercial 

information (5 U.S.C. 552b(c)(4)). This 

portion of the meeting must be closed 

because the Committee will be 

discussing trade secret and/or 

confidential data provided by the 

Federal Trade Commission and the 

tobacco industry. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caryn Cohen 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 10, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–634 Filed 1–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; California Health 

Interview Survey Cancer Control 

Module (CHIS–CCM) 2011 (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on November 15, 

2010 (75 FR 69681) and allowed 60 days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Proposed Collection: Title: California 

Health Interview Survey Cancer Control 

Module (CHIS–CCM) 2011. Type of 


srobinson on DSKHWCL6B1PROD with NOTICES