0614 SS for 2017 Extension

FOOD AND DRUG ADMINISTRATION
Exceptions or Alternatives to Labeling Requirements
for Products Held By the Strategic National Stockpile
OMB Control No. 0910-0614
SUPPORTING STATEMENT

A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations regarding
Exceptions or Alternatives to Labeling Requirements for Products Held By the Strategic National
Stockpile. Accordingly, we are requesting an extension of Office of Management and Budget
(OMB) approval of the information collection provisions found in the associated regulations and
discussed here:
21 CFR 201.26(b)(1)(i) Reporting: A Strategic National Stockpile (SNS) official or any
entity that manufactures (including labeling, packing, relabeling, or repackaging),
distributes, or stores a human drug product that is or will be included in the SNS may
submit, with written concurrence from a SNS official, a written request for an exception or
alternative to certain labeling requirements to the appropriate FDA Center Director.
21 CFR 610.68(b)(1)(i) Reporting: A Strategic National Stockpile official or any entity
that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or
stores a biological product that is or will be included in the SNS may submit, with written
concurrence from a SNS official, a written request for an exception or alternative to certain
labeling requirements to the appropriate FDA Center Director.
21 CFR 801.128(b)(1)(i) Reporting: A Strategic National Stockpile official or any entity
that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or
stores a device that is or will be included in the SNS may submit, with written concurrence
from a SNS official, a written request for an exception or alternative to certain labeling
requirements to the appropriate FDA Center Director.
21 CFR 809.11(b)(1)(i) Reporting: A Strategic National Stockpile official or any entity
that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or
stores an in vitro diagnostic product for human use that is or will be included in the SNS
may submit, with written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the appropriate FDA Center
Director.
Under the Public Health Service Act (PHS Act), the Department of Health and Human Services
(HHS) stockpiles medical products that are essential to the security of the nation (section 319F-2

of the PHS Act (42 U.S.C. 247d-6b)). This collection of medical products for use during national
health emergencies, known as the SNS, is to “provide for the emergency health security of the
United States, including the emergency health security of children and other vulnerable
populations, in the event of a bioterrorist attack or other public health emergency.”
It may be appropriate for certain medical products that are or will be held in the SNS to be labeled
in a manner that would not comply with certain FDA labeling regulations, given their anticipated
circumstances of use in an emergency. However, noncompliance with these labeling
requirements could have rendered such products misbranded under section 502 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352).
2. Purpose and Use of the Information Collection
The appropriate FDA Center Director may grant an exception or alternative to certain FDA
labeling requirements if compliance with the requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included in the SNS. An exception or
alternative granted under the regulations may include conditions or safeguards so that the labeling
for such products includes appropriate information necessary for the safe and effective use of the
product given the product’s anticipated circumstances of use. This facilitates the safety,
effectiveness, and availability of appropriate medical countermeasures in the event of a public
health emergency.
If the request is granted, the manufacturer may need to report to FDA any resulting changes to the
new drug application (NDA), biologics license application (BLA), premarket approval application
(PMA), or premarket notification (510(k)) in effect, if any. The submission and grant of a request
for an exception or alternative to the labeling requirements may be used to satisfy certain reporting
obligations relating to changes to product applications under 21 CFR 314.70 (human drugs), 21
CFR 601.12 (biological drugs), 21 CFR 814.39 (medical devices subject to premarket approval),
or 21 CFR 807.81 (medical devices subject to premarket notification submission (510(k)
clearance) requirements).
3. Use of Improved Information Technology and Burden Reduction
One of FDA’s continuing objectives is to improve the speed and quality of its review and
approval programs. To make the review process more efficient for industry and FDA, FDA
utilizes electronic information system technologies. FDA believes the increased use of computerassisted information technology enhances the timeliness, effectiveness, and efficiency of the
review process and reduces burdensome, nonessential hard-copy handling and storage. FDA is
not aware of any other improved technology to reduce the burden.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.

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5. Impact on Small Businesses or Other Small Entities
This collection of information applies to both small and well as large establishments. Although
FDA must apply the statutory and regulatory requirements equally to all enterprises, FDA does
provide special help to small businesses. The Center for Biologics Evaluation and Research,
Office of Communications, Outreach, and Development, Division of Manufacturer’s Assistance
and Training, the Center for Drug Evaluation and Research, Office of Communication, Division
of Drug Information, and the Center for Devices and Radiological Health, Office of
Communication and Education, Division of Industry and Consumer Education provide assistance
to small businesses subject to FDA’s regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
Less frequent collection of this and other information would not provide the information that
FDA needs to facilitate the safety, effectiveness, and availability of appropriate medical
countermeasures in the event of a public health emergency.
There are no technical or legal obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
An entity may be required to submit to FDA proprietary trade secret or other confidential
information when submitting a request for an exception or alternative to the labeling
requirements. FDA protects confidential information received from manufacturers to the extent
permitted by law.
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 May 23, 2017 (82 FR 23584). No public comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) and FDA’s published regulations of “Public Information” under 21 CFR
Part 20, and 21 CFR 312.130, 314.430, 601.50, 601.51, 807.95, 809.4, 812.38, and 814.122.
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this collection of information.
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12. Estimates of Annualized Burden Hours and Costs
12.a. Annualized Hour Burden Estimate
The total annual estimated burden of this collection of information is 32 hours, as reflected
in Table 1, below.
Table 1. – Estimated Annual Reporting Burden
21 CFR Section

201.26(b)(1)(i),
610.68(b)(1)(i),
801.128(b)(1)(i)
809.11(b)(1)(i)
201.26(b)(1)(i);
610.68(b)(1)(i);
801.128(b)(1)(i) and
809.11(b)(1)(i)
[Changes]
Total

No. of
Respondents

No. of Responses
per Respondent

Total Annual
Responses

Total
Hours

1

Average
Burden per
Response
24

1

1

1

1

1

8

8

24

32

Respondents to this collection of information are entities that manufacture (including labeling,
packing, relabeling, or repackaging), distribute, or store affected products.
Based on the number of requests for an exception or alternative received by FDA in fiscal years
2014 and 2015, FDA estimates an average of one request annually. FDA is estimating that each
respondent will spend an average of 24 hours preparing each request. The average burden per
response for each submission is based on the estimated time that it takes to prepare a supplement
to an application which may be considered similar to a request for an exception or alternative. To
the extent that labeling changes not already required by FDA regulations are made in connection
with an exception or alternative granted under the regulations, FDA is estimating one occurrence
annually in the event FDA would require any additional labeling changes not already covered by
FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes.
The information collection provisions in 21 CFR 314.70, 601.12, 807.81 and 814.39 have been
approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-0231,
respectively.

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12.b. Annualized Cost Burden Estimate
The estimated annual cost to respondents is $2,208.
Activity
Reporting

No. of Hours

Cost per Hour

32

$69.00

Total Cost
$2,208

The cost estimate is based on a regulatory affairs specialist, at a pay rate of $69.00 per hour, who
would be responsible for preparing a submission to FDA. The estimated average hourly pay rate
includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Record Keepers/CapitalCosts
There are no capital costs or operating or maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
The estimated annual cost to FDA is $2,880.
Activity
Review & Process

Number of
Reviews
2

Average Hours
per Review
20

Average Cost
per Hour
$72.00

Total Cost
$2,880

This cost estimate is based on FDA regulatory review staff with an average pay of $72 per hour
spending an estimated average of 20 hours to review and process the submissions to FDA. This
salary estimate includes benefits but no overhead costs.
15. Explanation for Program Changes or Adjustments
The estimated total annual burden for this information collection in 2014 was 32 hours. Based on
a review of more current data we have made no change in our burden estimate for the information
collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt display of the OMB Expiration Date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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