Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63833 

maintained in the Quality System is 

burdensome and provides no value to 

ensuring protection of public health. 

FDA agrees with these comments and 

has revised the guidance to recommend 

that only the parts of the Plan that could 

have an effect on product quality be 

reviewed and approved by the Quality 

Unit before implementation of the Plan. 

One comment stated that with 

adequate inventory on hand, an 

absenteeism-specific business plan 

might not be needed. FDA disagrees 

with the comment. As we discussed in 

the guidance, potential shortages could 

arise from emergencies not 

contemplated by inventory policy. 

One comment stated that establishing 

provisions to use resources available at 

other sites will require significant effort. 

FDA recommends that these provisions 

be considered as part of the overall Plan 

for handling emergencies. 

Some comments suggested different 

timeframes for notifying FDA of 

activation and deactivation of the Plan, 

stating that 1 day is too short a time. 

FDA did not change its recommendation 

for 1-day notification for Plan activation 

and deactivation because informing 

FDA of this activity in as close to real 

time as possible will assist the FDA in 

making critical decisions related to 

managing the causal event. 

Some comments stated that testing the 

implementation of the Plan and 

producing test batches would be 

impractical and expensive. FDA agrees 

with these comments and has revised its 

recommendation to test the 

implementation of the Plan and 

removed its recommendation to produce 

test batches of the drug product. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Notify FDA of Plan activation and deactivation ................... 2 1 2 16 32 

Total .............................................................................. ........................ ........................ ........................ ........................ 32 

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

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

Develop initial Plan .............................................................. 70 1 70 500 35,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 35,000 

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

Dated: October 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26103 Filed 10–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; the NIH–American 

Association for Retired Persons 

(AARP) Interactive Comprehensive 

Lifestyle Interview by Computer Study 

(iCLIC) (NCI) 

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

PROPOSED COLLECTION: Title: NIHAmerican Association for Retired 

Persons (AARP) interactive 

Comprehensive Lifestyle Interview by 

Computer Study (iCLIC). Type of 

Information Collection Request: 

Extension. Need and Use of Information 

Collection: The Nutritional 

Epidemiology Branch of the Division of 

Cancer Epidemiology and Genetics of 

the National Cancer Institute has 

planned this study to evaluate the 

feasibility of using these three new 

computerized questionnaires as well as 

the Diet and Health Questionnaire 

(DHQ), a well-established food 

frequency questionnaire in a population 

of early-to-late-middle-aged men and 

women. Participants will be asked to 

complete computerized questionnaires 

over a 90 day period, with some 

questionnaires in a series being 

completed twice. This evaluation study 

comprises the necessary performance 

and feasibility tests for the new 

computerized questionnaires, which 

will provide an opportunity to assess 

the possibility of administering 

computerized questionnaires in future 

large prospective cohort studies. The 

computerized questionnaires will 

support the ongoing examination 

between cancer and other health 

outcomes with nutritional, physical 

activity, and lifestyle exposures. The 

computerized questionnaires adhere to 

The Public Health Service Act, Section 

412 (42 U.S.C. 285a–1) and Section 413 

(42 U.S.C. 285a–2), which authorizes 

the Division of Cancer Epidemiology 

and Genetics of the National Cancer 

Institute (NCI) to establish and support 

programs for the detection, diagnosis, 

prevention and treatment of cancer; and 

to collect, identify, analyze and 

disseminate information on cancer 

research, diagnosis, prevention and 

treatment. Frequency of Response: 

Either 1 or 2 times. Affected Public: 

Individuals. Type of Respondents: U.S. 

adults (aged 50 and over). The annual 

reporting burden is displayed in the 

table below. The estimated total 

annualized burden hours being 

requested is 6886. The annualized cost 

to respondents is estimated at $121,743. 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

mstockstill on DSKH9S0YB1PROD with NOTICES

63834 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Instrument(s) tested Frequency of 

response 

Average time per 

response 

(minutes/hour) 

Number of 

respondents 

Annual hour 

burden 

Read Invitation (Attachments 3) .............................................. 1.00 1/60 (0.017) 16,667.00 278 

Pre-Enrollment (Attachment 6) ................................................ 1.00 10/60 (0.167) 2,312.00 385 

Enrollment Process (Attachment 7) ......................................... 1.00 5/60 (0.083) 2,288.00 191 

ASA24 (Attachments 4–1) ....................................................... 2.00 30/60 (0.500) 1,944.00 1,944 

ACT–24 (Attachments 4–2) ..................................................... 2.00 15/60 (0.250) 1,944.00 972 

LHQ (Attachments 4–3) ........................................................... 1.00 20/60 (0.333) 1,944.00 648 

DHQ (Attachments 4–4) .......................................................... 1.00 45/60 (0.750) 1,944.00 1,458 

Web Re-entry (Attachment 8) .................................................. 6.00 5/60 (0.083) 1,944.00 972 

Evaluation Survey (Attachment 9) ........................................... 1.00 1/60 (0.017) 2,288.00 38 

Totals ................................................................................ .............................. .............................. 33,275.00 6,886 

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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Arthur Schatzkin, 

M.D., Dr.P.H, Chief, Nutritional 

Epidemiology Branch, Division of 

Cancer Epidemiology and Genetics, 

National Cancer Institute, NIH, DHHS, 

Executive Plaza South, Room 3040, 

6120 Executive Blvd., EPS–MSC 7242, 

Bethesda, MD 20892–7335 or call nontoll-free number 301–594–2931 or email your request, including your 

address to: schatzka@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: October 12, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–26187 Filed 10–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0273] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Quality System 

Regulations 

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 November 

17, 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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0073. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

Medical Devices: Current Good 

Manufacturing Practice Quality System 

Regulations—21 

CFR Part 820 (OMB Control Number 

0910–0073)—Extension 

Under section 520(f) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C act) (21 U.S.C. 360j(f)), the 

Secretary of the Department of Health 

and Human Services has the authority 

to prescribe regulations requiring that 

the methods used in, and the facilities 

and controls used for, the manufacture, 

preproduction design validation 

(including a process to assess the 

performance of a device but not 

including an evaluation of the safety 

and effectiveness of a device), packing, 

storage, and installation of a device 

conform to current good manufacturing 

practice (CGMP), as described in such 

regulations, to assure that the device 

will be safe and effective and otherwise 

in compliance with the act. 

The CGMP/quality system (QS) 

regulation implementing authority 

provided by this statutory provision is 

found under part 820 (21 CFR part 820) 

and sets forth basic CGMP requirements 

governing the design, manufacture, 

packing, labeling, storage, installation, 

and servicing of all finished medical 

devices intended for human use. The 

authority for this regulation is covered 

under sections 501, 502, 510, 513, 514, 

515, 518, 519, 520, 522, 701, 704, 801, 

and 803 of the FD&C act (21 U.S.C. 351, 

352, 360, 360c, 360d, 360e, 360h, 360i, 

360j, 360l, 371, 374, 381, and 383). The 

CGMP/QS regulation includes 

requirements for purchasing and service 

controls, clarifies recordkeeping 

requirements for device failure and 

complaint investigations, clarifies 

requirements for verifying/validating 

production processes and process or 

product changes, and clarifies 

mstockstill on DSKH9S0YB1PROD with NOTICES