63832 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0568] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Draft Guidance for 

Industry on Planning for the Effects of 

High Absenteeism to Ensure 

Availability of Medically Necessary 

Drug Products 

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–NEW and 

title Draft Guidance for Industry on 

Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products 

(MNPs). Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400Q, Rockville, MD 20850, 301– 

796–7392, 

Elizabeth.berbakos@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. 

Draft Guidance for Industry on 

Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products 

The draft guidance recommends that 

manufacturers of drug and therapeutic 

biological products and manufacturers 

of raw materials and components used 

in those products develop a written 

Emergency Plan (Plan) for maintaining 

an adequate supply of MNPs during an 

emergency that results in high employee 

absenteeism. The draft guidance 

discusses the issues that should be 

covered by the Plan, such as: (1) 

Identifying a person or position title (as 

well as two designated alternates) with 

the authority to activate and deactivate 

the Plan and make decisions during the 

emergency; (2) prioritizing the 

manufacturer’s drug products based on 

medical necessity; (3) identifying 

actions that should be taken prior to an 

anticipated period of high absenteeism; 

(4) identifying criteria for activating the 

Plan; (5) performing quality risk 

assessments to determine which 

manufacturing activities may be 

reduced to enable the company to meet 

a demand for MNPs; (6) returning to 

normal operations and conducting a 

post-execution assessment of the 

execution outcomes; and (7) testing the 

Plan. The draft guidance recommends 

developing a Plan for each individual 

manufacturing facility as well as a 

broader Plan that addresses multiple 

sites within the organization (for 

purposes of this analysis, we consider 

the Plan for an individual 

manufacturing facility as well as the 

broader Plan to comprise one Plan for 

each manufacturer). Based on FDA’s 

data on the number of manufacturers 

that would be covered by the draft 

guidance, we estimate that 

approximately 70 manufacturers will 

develop an Emergency Plan as 

recommended by the draft guidance 

(i.e., 1 Plan per manufacturer to include 

all manufacturing facilities, sites, and 

drug products), and that each Plan will 

take approximately 500 hours to 

develop, maintain, and update. 

The draft guidance also encourages 

manufacturers to include a procedure in 

their Plan for notifying CDER when the 

Plan is activated and when returning to 

normal operations. The draft guidance 

recommends that these notifications 

occur within 1 day of a Plan’s activation 

and within 1 day of a Plan’s 

deactivation. The draft guidance 

specifies the information that should be 

included in these notifications, such as 

which drug products will be 

manufactured under altered procedures, 

which products will have 

manufacturing temporarily delayed, and 

any anticipated or potential drug 

shortages. We expect that approximately 

two notifications (for purposes of this 

analysis, we consider an activation and 

a deactivation notification to equal one 

notification) will be sent to CDER by 

approximately two manufacturers each 

year, and that each notification will take 

approximately 16 hours to prepare and 

submit. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

Under the draft guidance, if a 

manufacturer obtains information after 

releasing an MNP under its Plan leading 

to suspicion that the product might be 

defective, CDER should be contacted 

immediately 

(drugshortages@fda.hhs.gov) in 

adherence to existing recall reporting 

regulations (21 CFR 7.40) (OMB control 

number 0910–0249) or defect reporting 

requirements for drug application 

products (21 CFR 314.81(b)(1)) and 

therapeutic biological products 

regulated by CDER (21 CFR 600.14) 

(OMB control numbers 0910–0001 and 

0910–0458, respectively). 

The following collections of 

information found in FDA current good 

manufacturing practice (CGMP) 

regulations in part 211 (21 CFR part 

211) are approved under OMB control 

number 0190–0139. The draft guidance 

encourages manufacturers to maintain 

records, in accordance with the CGMP 

requirements (see, e.g., § 211.180), that 

support decisions to carry out changes 

to approved procedures for 

manufacturing and release of products 

under the Plan. The draft guidance 

states: A Plan should be developed, 

written, reviewed, and approved within 

the site’s change control quality system 

in accordance with the requirements in 

§§ 211.100(a) and 211.160(a); execution 

of the Plan should be documented in 

accordance with the requirements 

described in § 211.100(b); and standard 

operating procedures should be 

reviewed and revised or supplementary 

procedures developed and approved to 

enable execution of the Plan. 

In the Federal Register of January 8, 

2010 (75 FR 1060), FDA announced the 

availability of the draft guidance. In that 

Federal Register notice, FDA provided 

the public with 60 days to comment on 

the proposed collection of information. 

FDA received the following comments 

that pertained to the information 

collection in the draft guidance. 

Some comments stated that 

pharmaceutical companies already have 

business continuity plans that address 

shortages of medically necessary 

products and that these plans take into 

account high absenteeism and other 

factors that could affect production. 

FDA believes that a general business 

continuity plan is unlikely to take into 

account individual products or how 

execution of the plan would affect 

product quality. 

Some comments stated that the 

recommendation that the Plan be 

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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. 

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