0675 Planning for high absenteeism SSA 2020 EXT

UNITED STATES FOOD & DRUG ADMINISTRATION
Planning for the Effects of High Absenteeism
to Ensure Availability of Medically Necessary Drug Products
OMB Control No. – 0910-0675
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations and related agency guidance. The document entitled, “Guidance for Industry;
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug
Products (MNPs)” provides recommendations to manufacturers of drug and therapeutic biological
products and manufacturers of raw materials and components used in those products for
developing a written plan to maintain an adequate supply of MNPs during an emergency that
results in high employee absenteeism. The guidance discusses issues such as: (1) identifying a
person or position title (as well as two designated alternates) with the authority to activate and
deactivate a plan (hereafter, “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 guidance recommends developing a Plan for each individual manufacturing facility as well as
a broader Plan that addresses multiple sites within the organization.
The guidance also encourages manufacturers to include a procedure in their Plan for notifying
FDA’s Center for Drug Evaluation and Research (CDER) when the Plan is activated and when
returning to normal operations. The guidance recommends that these notifications occur within 1
day of a Plan’s activation and within 1 day of a Plan’s deactivation. The 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. The guidance is intended to assist
respondents to information collection requirements found in 21 CFR part 211 pertaining to CGMP
and finished pharmaceuticals (currently approved under OMB control no. 0910-0139), specifically
with regard to personnel organization in subpart B and production and process controls in subpart
F.
We therefore request extension of OMB approval for the information collection as discussed in
this supporting statement.

2. Purpose and Use of the Information Collection
The guidance recommends that manufacturers develop, maintain, and update a written plan (i.e., 1
Plan per manufacturer to include all manufacturing facilities, sites, and drug products). In
addition, manufacturers are encouraged to include a procedure for notifying CDER when the plan
is activated and when returning to normal operations. The guidance recommends that these
notifications to occur within 1 day of activation and within 1 day of deactivation.
3. Use of Improved Information Technology and Burden Reduction
Although not specifically addressed in the guidance, we assume that manufacturers will rely on
their standard electronic information technology systems to develop and maintain the Plan
recommended in the guidance, including the use of standard email technology to notify CDER at
the email address given in the guidance. Therefore, we assume 100% of respondents will utilize
electronic means to notify FDA.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We are unaware of undue burden on small entities.
6. Consequences of Collecting the Information Less Frequently
We believe that by following the recommendations in the guidance, including the reporting
timeframes, manufacturers will help avoid or mitigate disruptions in supply of MNPs during
emergencies that result in high absenteeism at production facilities.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The information collection recommendations in the guidance are consistent with the guidelines in
5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice inviting public comment in the
Federal Register of October 25, 2019 (84 FR 57448). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
There are no questions of a sensitive nature associated with the information collection.

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10. Assurance of Respondent Privacy and Confidentiality
No personally identifiable information (PII) or other data of a personal nature is being collected.
Information is collected from manufacturers of (1) drug and therapeutic biological products and
(2) raw materials and components used in those products and addresses the development of a
written Emergency Plan for an adequate supply of medically necessary drug products (MNPs) and
procedures in the Plan for notifying FDA. In preparing this Supporting Statement, we consulted
our Privacy Office to ensure appropriate handling of information collected. Confidentiality of the
information submitted as recommended in the guidance is protected under 21 CFR 312.130 and 21
CFR part 20. The unauthorized use or disclosure of trade secrets required in applications is
specifically prohibited under section 310(j) of the FD&C Act.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature associated with the information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate:
Table 1.--Estimated Annual Reporting Burden
No. of
No. of
Total
Avg. Burden
Respondents
Responses
Annual
per Response
per
Responses
Respondent
Activate/deactivate Plan as
2
1
2
16
recommended in the guidance

Activity

Table 2.--Estimated Annual Recordkeeping Burden
Activity
No. of
No. of
Total
Recordkeepers Records per
Annual
Recordkeeper Records
Develop initial Plan as
70
1
70
recommended in the guidance

Total
Hours

32

Avg. Burden Total
per
Hours
Recordkeeper
250
17,500

12b. Annualized Cost Burden Estimate
We assume labor costs associated with preparing and maintaining the Emergency Plan and
notifying FDA of the Plan activation and deactivation in the amount of $85 per hour (averaged
from wages for upper management, middle management, and clerical support, plus overhead and
personnel benefits), for a total annual cost of $1,447,720.

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13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, or operating or maintenance costs associated with the information
collection.
14. Annualized Cost to the Federal Government
The information collection is covered by existing agency resource allocations.
15. Explanation for Program Changes or Adjustments
Upon development of a plan for the effects of high absenteeism to ensure availability of MNPs,
we believe fewer hours are necessary for maintaining the plan and making updates. Since
establishing the information collection in 2011, we believe most respondents have developed a
plan as recommended by the guidance. Accordingly, we have reduced burden we attribute to
recordkeeping activities by half resulting in 17,500 fewer burden hours.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no publications or other schedules associated with the information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date as required by 5 CFR 1320.5 is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification statement.

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