Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 59265 

October 20, 2010, from 8:30 a.m. until 

5:15 p.m. 

ADDRESSES: U.S. Department of Health 

and Human Services, 200 Independence 

Avenue SW., Hubert H. Humphrey 

Building, Room 800, Washington, DC 

20201. 

FOR FUTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections (OHRP), or 

Julia Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; 240–453–8141; fax: 

240–453–6909; e-mail address: 

Julia.Gorey@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services and the 

Assistant Secretary for Health on issues 

and topics pertaining to or associated 

with the protection of human research 

subjects. 

On October 19, 2010, SACHRP will 

hear a panel of four experts discuss the 

evolving concepts of identifiability and 

anonymization of data in the context of 

current and future research. Following 

the panel, the Subcommittee on 

Harmonization (SOH) will present a 

report. The SOH was established by 

SACHRP at its July 2009 meeting, and 

is charged with identifying and 

prioritizing areas in which regulations 

and/or guidelines for human subjects 

research adopted by various agencies or 

offices within HHS would benefit from 

harmonization, consistency, clarity, 

simplification and/or coordination. 

On October 20, 2010, the morning 

will begin with a panel discussing the 

use of deception in human subjects 

research. Subpart A Subcommittee 

(SAS) will make a report focusing on 

improvements to the informed consent 

process. SAS is charged with 

developing recommendations for 

consideration by SACHRP about the 

application of subpart A of 45 CFR part 

46 in the current research environment. 

This subcommittee was established by 

SACHRP at its October 2006 meeting. 

Public comment will be heard on both 

days. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend the meeting and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the designated contact persons. 

Members of the public will have the 

opportunity to provide comments on 

both days of the meeting. Public 

comment will be limited to five minutes 

per speaker. Any members of the public 

who wish to have printed materials 

distributed to SACHRP members for this 

scheduled meeting should submit 

materials to the Executive Director, 

SACHRP, prior to the close of business 

Friday, October 15, 2010. 

Dated: September 21, 2010. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections, Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. 2010–24128 Filed 9–24–10; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60-Day–10–10GY] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 to 

provide opportunity for public comment 

on proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited 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) 

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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Community Assessment and 

Engagement Process—New—Division of 

Health Assessment and Consultation 

(DHAC), Agency for Toxic Substances 

and Disease Registry (ATSDR), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

ATSDR serves the public through 

responsive public health actions to 

promote healthy and safe environments 

and to prevent harmful exposures. To 

effectively implement ATSDR’s 

programs, the agency works with 

communities by listening to and 

understanding their health concerns and 

seeking their guidance on where, when, 

and how to take public health actions. 

Communities in proximity to hazardous 

waste sites are concerned that they are 

being exposed to hazardous substances 

being released into the environment. 

Community assessment data will enable 

ATSDR to determine the perceived 

needs, concerns, values, and priorities 

of communities we serve and determine 

their willingness, interest and ability to 

participate in community engagement 

activities. 

In order to secure this data, ATSDR 

will interview adult males and females 

ages 18 and over living near petitioned 

or National Priorities List sites. ATSDR 

will also identify health and other 

concerns and the most effective 

channels of communication and venues 

for engagement. 

ATSDR staff will work with key 

stakeholders in communities to 

interview participants. These interviews 

will take the form of in-depth or 

telephone interviews with five 

audiences: General residential 

population (n = 600), public/private 

health care providers (n = 200), 

community leaders (n = 200), elected 

officials (n = 100), and industry leaders 

(n = 100). 

In-depth Interviews will take place at 

the individual’s residence, at a 

predetermined interview location, at 

ATSDR-sponsored town hall meetings, 

or other ATSDR-sponsored functions. 

Telephone interviews will take place at 

the individual’s residence or business 

location. Findings from these interviews 

will be used to determine how ATSDR 

will engage the community in 

addressing environmental concerns. 

Interview findings will also help 

ATSDR reach as many of the members 

of the affected community as possible 

and ensure that all community members 

are given an opportunity to provide 

input to ATSDR regarding public health 

assessment and community 

involvement activities. There are no 

costs to the respondents other than their 

time. 


srobinson on DSKHWCL6B1PROD with NOTICES
59266 Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Responses per 

respondent 

Average burden 

per response 

(in hours) 

Total burden 

hours 

General Resident .......................... In-depth Interview/phone .............. 600 1 1.5 900 

Screener ....................................... 1,200 1 6/60 120 

Health care provider ..................... In-depth Interview/phone .............. 200 1 .5 100 

Screener ....................................... 400 1 6/60 40 

Community Leader ........................ In-depth Interview/phone .............. 200 1 1.5 300 

Screener ....................................... 400 1 6/60 40 

Elected Official .............................. In-depth Interview/phone .............. 100 1 .5 50 

Industry ......................................... In-depth Interview/phone .............. 100 1 .5 50 

Total ....................................... ....................................................... .......................... .......................... .......................... 1,600 

Dated: September 21, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–24181 Filed 9–24–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0355] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

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 27, 

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 0910–0606. 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. 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements (OMB Control Number 

0910–0606)—Extension 

On October 25, 1994, the Dietary 

Supplement Health and Education Act 

(DSHEA) (Public Law 103–417) was 

signed into law. DSHEA, among other 

things, amended the Federal Food, 

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

by adding section 402(g) of the FD&C 

Act (21 U.S.C. 342(g)). Section 402(g)(2) 

of the FD&C Act provides, in part, that 

the Secretary of Health and Human 

Services (the Secretary) may, by 

regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g) of the 

FD&C Act also stipulates that such 

regulations shall be modeled after 

current good manufacturing practices 

(CGMPs) regulations for food and may 

not impose standards for which there 

are no current, and generally available, 

analytical methodology. Section 

402(g)(1) of the FD&C Act states that a 

dietary supplement is adulterated if ‘‘it 

has been prepared, packed, or held 

under conditions that do not meet 

current good manufacturing practice 

regulations.’’ Under section 701(a) of the 

FD&C Act (21 U.S.C. 371), FDA may 

issue regulations necessary for the 

efficient enforcement of the FD&C Act. 

FDA published a final rule on June 25, 

2007 (72 FR 34752) (the final rule) that 

established, in part 111 (21 CFR part 

111), the minimum CGMPs necessary 

for activities related to manufacturing, 

packaging, labeling, or holding dietary 

supplements to ensure the quality of the 

dietary supplement. 

Records are an indispensable 

component of CGMPs. The records 

required by FDA’s regulations in part 

111 provide the foundation for the 

planning, control, and improvement 

processes that constitute a quality 

control system. Implementation of these 

processes in a manufacturing operation 

serves as the backbone to CGMPs. The 

records will show what is to be 

manufactured; what was, in fact, 

manufactured; and whether the controls 

that the manufacturer put in place to 

control the identity, purity, strength, 

and composition and limits on 

contaminants and to prevent 

adulteration were effective. Further, 

records will show whether and what 

deviations from control processes 

occurred, facilitate evaluation and 

corrective action concerning these 

deviations (including, where necessary, 

whether associated batches of product 

should be recalled from the 

marketplace), and enable a 

manufacturer to assure that the 

corrective action was effective. In 

addition, by requiring records, FDA will 

be able to ensure that industry follows 

CGMPs during manufacturing, 

packaging, labeling, or holding 

operations. The regulations in part 111 

establish the minimum manufacturing 

practices necessary to ensure that 

dietary supplements are manufactured, 

packaged, labeled, or held in a manner 

that will ensure the quality of the 

dietary supplements during 

manufacturing, packaging, labeling or 

holding operations. 

The records requirements of the 

regulations include written procedures 

and records pertaining to: (1) Personnel; 

(2) sanitation; (3) calibration of 

instruments and controls; (4) 

calibration, inspection, or checks of 

automated, mechanical, or electronic 

equipment; (5) maintaining, cleaning, 

and sanitizing equipment and utensils 

and other contact surfaces; (6) water 


srobinson on DSKHWCL6B1PROD with NOTICES