Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 61763 

Dated: September 30, 2010. 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–25198 Filed 10–5–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission of OMB Review; Comment 

Request; Drug Accountability Record 

(Form NIH 2564) (NCI) 

SUMMARY: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute, the National 

Cancer Institute (NIH) has submitted to 

the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collected 

below. This proposed information 

collection was previously published in 

the Federal Register on August 4, 2010 

(75 FR 46945) 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 

March 1, 2011, unless it displays a valid 

OMB control number. 

Proposed Collection: Title: Drug 

Accountability Record (NCI) (Form NIH 

2564) (OMB No.0925–0240). Type of 

Information Collection Request: 

Extension with changes. Need and Use 

of Information Collection: Food and 

Drug Administration (FDA) regulations 

require investigators to establish a 

record of the receipt, use and 

disposition of all investigational agents. 

The National Cancer Institute (NCI), as 

a sponsor of investigational drug trials, 

has the responsibility to assure the FDA 

that investigators in its clinical trials 

program are maintaining systems for 

drug accountability. In order to fulfill 

these requirements, a standard 

Investigational Drug Accountability 

Report Form (NIH 2564) was designed 

to account for drug inventories and 

usage by protocols. The data obtained 

from the drug accountability record will 

be used to keep track of the dispensing 

of investigational anticancer agents to 

patients. It is used by NCI management 

to ensure that investigational drug 

supplies are not diverted for 

inappropriate protocol or patient use. 

The information is also compared to 

patient flow sheets (protocol reporting 

forms) during site visits conducted for 

each investigator once every three years. 

All comparisons are done with the 

intention of ensuring protocol, patient 

and drug compliance for patient and 

drug compliance for patient safety and 

protections. Frequency of Response: 

Approximately 16 times per year. 

Affected Public: Private sector including 

businesses, other for-profit 

organizations, and non-profit 

institutions. Type of Respondents: 

Investigators, pharmacists, nurses, 

pharmacy technicians, and data 

managers. The annualized respondents’ 

burden is estimated to require 6,714 

hours (Table 1). There are no capital 

costs, operating costs, and maintenance 

cost to report. 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Annnual 

burden 

hours 

Investigators, or Designees ............................................................................. 4,196 16 6/60 

(0.1) 

6,714 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments or suggestions regarding the 

item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

times, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Charles 

L. Hall, Jr., Chief, Pharmaceutical 

Management Branch, Cancer Therapy 

Evaluation Program, Division of the 

Cancer Treatment and Diagnosis, and 

Centers, National Cancer Institute, 

Executive Plaza North, Room 7148, 9000 

Rockville Pike, Bethesda, MD 20892 or 

call non-toll-free number 301–496–5725 

or e-mail your request, including your 

address to: Hallch@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days following the 

date of this publication. 

Dated: September 27, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–25190 Filed 10–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; NCCAM Office of 

Communications and Public Liaison 

Communications Program Planning 

and Evaluation Research 

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, the National 

Center for Complementary and 

Alternative Medicine (NCCAM), the 

National Institutes of Health (NIH), has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

mstockstill on DSKH9S0YB1PROD with NOTICES

61764 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 

listed below. This proposed information 

collection was previously published in 

the Federal Register on August 25, 2010 

(Vol. 75, No. 164, p. 52349) and allowed 

60 days for public comment. There was 

one public comment received during 

this time. 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: NCCAM 

Office of Communications and Public 

Liaison Communications Program 

Planning and Evaluation Research. Type 

of Information Collection Request: 

Extension. 

Need and Use of Information 

Collection: To carry out NCCAM’s 

legislative mandate to educate and 

disseminate information about 

complementary and alternative 

medicine (CAM) to a wide variety of 

audiences and organizations, the 

NCCAM Office of Communications and 

Public Liaison (OCPL) requests 

clearance to carry out (1) formative and 

(2) evaluative research of a variety of 

print and online materials, outreach 

activities, and messages to maximize 

their impact and usefulness. 

OCPL wishes to continue to carry out 

formative research to further understand 

the knowledge, attitudes, and behaviors 

of its core constituent groups: Members 

of the general public, researchers, and 

providers of both conventional and 

CAM health care. In addition, it seeks to 

test newly formulated messages and 

identify barriers and impediments to the 

effective communication of those 

messages. With this formative audience 

research, OCPL tests audience responses 

to NCCAM’s fact sheets, Web content, 

and other materials and messages. 

Clearance is also requested to 

continue evaluative research on existing 

materials and messages, as part of 

OCPL’s ongoing effort to develop a 

comprehensive program of testing and 

evaluation of all of its communications 

strategies. This evaluative research will 

include pilot testing of recently 

developed messages and information 

products such as consumer fact sheets 

and brochures. It will address the need 

to evaluate the processes by which new 

materials and messages were developed, 

the effectiveness of an outreach activity 

or the extent to which behaviors were 

changed by the message, and the impact 

of a message on health knowledge and 

behaviors. 

The tools to collect this information 

have been selected to minimize burden 

on NCCAM’s audiences, produce or 

refine messages that have the greatest 

potential to influence target audience 

attitudes and behavior in a positive 

manner, and to use Government 

resources efficiently. They may include 

individual in-depth interviews, focus 

group interviews, intercept interviews, 

self-administered questionnaires, 

gatekeeper reviews, and omnibus 

surveys. 

The data will enhance OCPL’s 

understanding of the unique 

information needs and distinct healthinformation-seeking behaviors of its 

core constituencies, and the segments 

within these constituencies with special 

information needs (for example, among 

the general public these segments 

include cancer patients, the chronically 

ill, minority and ethnic populations, the 

elderly, users of dietary supplements, 

and patients integrating complementary 

therapies with conventional medical 

treatments). 

Frequency of Response: On occasion. 

Affected Public: Individuals and 

households; non-profit institutions; 

Federal Government; State, Local, or 

Tribal Government. Type of 

Respondents: Adult patients; members 

of the public; health care professionals; 

organizational representatives. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

2,500; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours per Response: 0.58; and 

Estimated Total Burden Hours 

Requested: 2,109 for the 3-year 

clearance period (approximately 703 

hours annually). The annualized cost to 

respondents is estimated at $18,123. 

There are no Capital Costs, Operating 

Costs, or Maintenance Costs to report. 

TABLE 1—ANNUAL BURDEN HOURS

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

In-depth interviews with general public ........................................................... 30 1 .75 23 

Focus groups ................................................................................................... 20 1 1.5 30 

Omnibus surveys ............................................................................................. 1,900 1 0.25 475 

Intercept interviews with public and healthcare professionals ........................ 300 1 0.25 75 

In-depth interviews with health professionals .................................................. 50 1 .50 25 

Self-administered questionnaires with health professionals ............................ 200 1 .25 50 

TOTAL ...................................................................................................... 2,500 ........................ ........................ 678 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Christy 

Thomsen, Director, Office of 

Communications and Public Liaison, 

NCCAM, 31 Center Drive, Room 2B11, 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices 61765 

Bethesda, MD 20892, or fax your request 

to 301–402–4741, or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: September 29, 2010. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. 2010–25170 Filed 10–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Correction in Burden Table. 

SUMMARY: The Health Resources and 

Services Administration published an 

Agency Information Collection 

document in the Federal Register of 

September 17, 2010 (FR Doc. 201– 

023260), on page 57037, regarding the 

Black Lung Clinics Program Database 

(OMB No. 0915–0292). In the burden 

table, the Total responses, Hours per 

response and Total burden hours are 

incorrect. 

Correction 

In the Federal Register issue of 

September 17, 2010, FR Doc. 201– 

023260, on page 57037, correct the Total 

responses, Hours per response and Total 

burden hours as follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Database .............................................................................. 15 1 15 20 300 

Dated: September 28, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–25113 Filed 10–5–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Diabetes, 

Endocrinology and Metabolic Diseases B 

Subcommittee, October 20, 2010, 5 p.m. 

to October 22, 2010, 5 p.m., Hyatt 

Regency Bethesda, One Bethesda Metro 

Center, 7400 Wisconsin Avenue, 

Bethesda, MD 20814 which was 

published in the Federal Register on 

September 15, 2010, 75 FR 56117. 

The meeting has been changed to 

October 20, 2010, 5 p.m. to October 21, 

2010, 5 p.m. The location remains the 

same. The meeting is partially closed to 

the public. 

Dated: September 30, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–25175 Filed 10–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

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 meeting. 

The meeting 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: Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development Special Emphasis 

Panel; ‘‘Reproductive Panel’’. 

Date: November 3–5, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, Montgomery County 

Conference Center Facility, 5701 Marinelli 

Road, North Bethesda, MD 20852. 

Contact Person: Dennis E. Leszczynski, 

PhD, Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 5B01, Bethesda, MD 20892, 

301–435–6884, leszczyd@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 30, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–25178 Filed 10–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES