0675 SS for 2017 Extension

Food and Drug Administration
Guidance for Industry (GFI): Planning for the Effects of High Absenteeism
to Ensure Availability of Medically Necessary Drug Products
OMB Control Number 0910-0675
Supporting Statement

A. Justification
1. Circumstances Making the Collection of Information Necessary
The information collection supports agency guidance entitled, “Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug Products.” The guidance
provides recommendations to manufacturers of drug and therapeutic biological products and
manufacturers of raw materials and components used in those for developing a written
Emergency Plan (the Plan) to maintain an adequate supply of medically necessary drug products
(MNPs) during an emergency that results in high employee absenteeism. The 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 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 stimulate planning to avoid or mitigate disruptions in supply of
MNPs during emergencies that result in high absenteeism at production facilities, and to provide
to industry considerations for developing emergency plans, as well as to discuss CDER’s
intended approach to assist in avoiding shortages that may have a negative impact on the national
public health during such emergencies.
2. Purpose and Use of the Information Collection
The guidance recommends that manufacturers develop, maintain, and update a Plan as specified
in the guidance (i.e., 1 Plan per manufacturer to include all manufacturing facilities, sites, and

2

drug products). In addition, manufacturers are encouraged to include a procedure in their Plan
for notifying 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.
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% electronic compliance.
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
The guidance applies to both large and small manufacturers of drug and therapeutic biologic
products regulated by CDER, and any components of those products. Under the Regulatory
Flexibility Act, FDA regularly analyzes regulatory options that would minimize any significant
impact on small entities. FDA also assists small businesses in complying with regulatory
requirements.
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
This guidance contains no inconsistency 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), FDA published a 60 day notice for public comment in the
Federal Register of November 3, 2016 (81 FR 76618). We received no comments that pertained
to the information collection analysis.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents to the information collection.

3

10. Assurance of Confidentiality Provided to Respondents
Although we do not anticipate any confidentiality issues resulting from the information
collection in the guidance, confidentiality of information submitted under marketing applications
is protected under 21 CFR 314.430 and 21 CFR part 20. In addition, 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.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Hours
For purposes of this information collection 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 guidance, we estimate that approximately 70 manufacturers will develop a Plan as
recommended by the 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 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
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. 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.
The guidance also refers to previously approved collections of information found in FDA
regulations. Under the 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 at [email protected] 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).
In addition, the following collections of information found in FDA current good
manufacturing practice (CGMP) regulations in part 211 (21 CFR part 211) are approved under

4

OMB control number 0190-0139. The 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 guidance states that 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.
FDA estimates the burden of this information collection as follows:
Table 1.--Estimated Annual Reporting Burden
Activity

No. of
Respondents

Activation/deactivation of
Plan as recommended in
GFI

2

No. of
Responses per
Respondent
1

Total
Annual
Responses
2

Average
Burden per
Response
16

Total
Hours
32

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

Table 2.--Estimated Annual Recordkeeping Burden
Activity
Develop Initial Plan as
recommended in GFI

No. of
Recordkeepers

No. of Records per
Recordkeeper

70

1

Total
Annual
Records
70

Average
Burden per
Recordkeeping
500

Total
Hours
35,000

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

12b. Annualized Cost Burden Estimate
There are labor costs associated with preparing and maintaining the Emergency Plan, and
notifying FDA of the Plan activation and deactivation. Assuming a wage rate of approximately
$85 per hour (averaged from wages for upper management, middle management, and clerical
support, plus overhead and personnel benefits), we estimate the costs to be approximately
$2,977,720.
13. Estimates of Other Total Annual Cost Burden to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
The information collection is covered by existing agency resource allocations.

5

15. Explanation for Program Changes or Adjustments
There are no changes from the currently approved burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no such plans.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.