0688 SS for 2017 Renewal

FOOD AND DRUG ADMINISTRATION
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally
Recognized as Safe and Effective and Not Misbranded; Guidance for Industry –
Time and Extent Applications for Nonprescription Drug Products
OMB Control No. 0910-0688
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA or we) regulations
regarding “Time and Extent Applications for Nonprescription Drug Products.” FDA’s legal
authority to regulate the ingredients contained in over-the-counter (OTC) drug products derives
from sections 321, 351, 352, 353, 355, 360, and 371 of the Federal Food, Drug, and Cosmetics
Act (the FD&C Act). FDA follows the procedures outlined in 21 CFR 330.10 for classifying
active ingredients in OTC drug products as generally recognized as safe and effective (GRASE)
and not misbranded.
Effective December 23, 2016, additional criteria and procedures by which OTC drugs initially
marketed in the United States after the OTC drug review began in 1972, and OTC drugs without
any U.S. marketing experience, may become eligible for consideration in the OTC drug
monograph system (see 67 FR 3060). The regulations in 21 CFR 330.14 define a two-step
process to include an ingredient in an OTC drug monograph (i.e., to classify the ingredient as
GRASE for a particular purpose). First, to determine whether a drug product is eligible to be
considered for inclusion in the OTC drug monograph system, certain information must be
submitted to FDA in a “time and extent application” (TEA) to show that a drug product meets
the criteria described in 21 CFR 330.14(b) (see 21 CFR 330.14(c) and (d)). Second, if the drug
product is found eligible, FDA will publish a notice of eligibility in the Federal Register
requesting that interested persons submit data to demonstrate the safety and effectiveness of the
drug product for its OTC use(s) (21 CFR 330.14(f)). To assist respondents with the information
collection provisions found in the regulations, FDA has created guidance regarding this process.
FDA, therefore, requests OMB approval of the information collection provisions found in 21
CFR 330.14 and the associated guidance entitled, Guidance for Industry: Time and Extent
Applications for Nonprescription Drug Products.
2. Purpose and Use of the Information Collection
Respondents (private sector businesses) collect information under the provisions of 21 CFR
330.14 to substantiate that an ingredient or ingredients are eligible to be considered for inclusion
in the OTC drug monograph system and, if so, to demonstrate that the ingredient or ingredients
can be classified as GRASE. FDA uses the information collected to determine eligibility (first

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part of two-step process) and, if determined eligible, to classify the ingredient(s) as GRASE or
not GRASE (second part of the process).
3. Use of Improved Information Technology and Burden Reduction
FDA expects information to be collected, reviewed, compiled, and submitted electronically
where possible. Based on our experience to date, FDA estimates that 95 percent or more of the
responses will be submitted electronically. FDA no longer requires that collected information be
submitted in hard copy and would prefer that the information be submitted electronically.
Submissions received in the last several years have been exclusively (100 percent) in electronic
format.
4. Efforts to Identify Duplication and Use of Similar Information
The data and information collected under the provisions of 21 CFR 330.14 do not duplicate any
other data and information that may be available to FDA. No other FDA regulations require
submission of the information required by 21 CFR 330.14(c) and (d). FDA may have data
required by 21 CFR 330.14(f) and (i) if it was submitted under new drug applications (NDAs).
In such situations, the data from NDAs can be cross-referenced to support the requirements of
21 CFR 330.14(f) and (i) and need not be resubmitted.
5. Impact on Small Businesses or Other Small Entities
There are no exceptions for small businesses/marketing enterprises. FDA provides assistance to
small businesses through guidance on its website and through small business liaison component
offices within the agency.
6. Consequences of Collecting the Information Less Frequently
The collections of information required under the provisions of 21 CFR 330.14 are one-time
burdens for the submitting parties. This information is needed to determine whether the
requirements of 21 USC 321(p) are satisfied.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
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 30, 2017 (82 FR 24716), but received no comments.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.

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10. Assurance of Confidentiality Provided to Respondents
Certain information submitted in a TEA or a safety and effectiveness submission may be
considered confidential. Under 21 CFR 330.14(d), all TEAs are handled as confidential upon
receipt until such time as a decision is made on the eligibility of the drug product. If the drug is
found to be eligible for inclusion in the OTC drug monograph system, any information that FDA
deems confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or section 301(j) of the act will be
removed from the TEA, and the remainder of the application will be placed on public display in
the Division of Dockets Management when the notice of eligibility is published (21 CFR
330.14(d))). If the condition is not found to be eligible, the TEA will not be placed on public
display, but a letter from FDA to the applicant stating why the condition was not found to be
eligible will be placed on public display in the Division of Dockets Management (21 CFR 330.14
(d)).
Under 21 CFR 330.14(f), safety and effectiveness data submitted in response to a notice of
eligibility will be made publicly available for viewing at the Division of Dockets Management,
except data deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or section 301(j) of the
act. Submissions must clearly identify data considered confidential under these provisions (21
CFR 330.14(f)). Proposed compendial standards will not be considered confidential (21 CFR
330.14(f)).
11. Justification for Sensitive Questions
There are no sensitive questions associated with the information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Burden Estimate
FDA Estimates the burden of the information collection as follows:
Table 1 – Estimated Annual Reporting Burden1
21 CFR Part 330;
Activity
330.14(c) and (d);
Time and extent
application and
submission of
information
330.14(f) and (i);
Safety and
effectiveness data
330.14(j)(3); sponsor
request for informal
conference
330.14(j)(4); sponsor
signed statement that

No. of
Respondents

No. of Responses
per Respondent

Total Annual
Responses

2

1

2

Average
Burden per
Response
1,525

Total Hours

2

1

2

2,350

4,700

1

1

1

1

1

2

1

2

1

2

3,050

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21 CFR Part 330;
Activity
submission is
complete
330.14(k)(l); sponsor
request for FDA
withdraw of TEA
consideration
330.14(k)(2);
sponsor request for
FDA to not deem
submission
withdrawn
TOTAL
1

No. of
Respondents

No. of Responses
per Respondent

Total Annual
Responses

Average
Burden per
Response

Total Hours

1

1

1

1

1

1

1

1

2

2

7,756

There are no capital costs or operating and maintenance costs associated with the information collection.

By final rule of November 23, 2016 (81 FR 84465), FDA revised the TEA regulations to
establish timelines and performance metrics for review of non-sunscreen TEAs, and safety and
effectiveness data submissions, as required by the Sunscreen Innovation Act:


Section 330.14(j) clarifies the requirements on content and format criteria for a safety and
effectiveness data submission, and provides procedures for FDA’s review of the
submissions and determination of whether a submission is sufficiently complete to permit
a substantive review. Section 330.14(j)(3) describes the process for cases in which FDA
refuses to file the safety and effectiveness data submission. Under §330.14(j)(3), if FDA
refuses to file the submission, the agency will notify the sponsor in writing, state the
reason(s) for the refusal, and provide the sponsor with 30 days in which to submit a
written request for an informal conference with the agency about whether the agency
should file the submission.



Under §330.14(j)(4)(iii), the safety and effectiveness data submission must contain a
signed statement that the submission represents a complete safety and effectiveness data
submission and that the submission includes all the safety and effectiveness data and
information available to the sponsor at the time of the submission, whether positive or
negative. Under § 330.14(k)(1), FDA, in response to a written request from a sponsor,
may withdraw consideration of a TEA submitted under § 330.14(c) or a safety and
effectiveness data submission submitted under § 330.14(f).



Under § 330.14(k)(2), a sponsor may request that FDA not withdraw consideration of a
TEA or safety and effectiveness data submission.
12b. Annualized Cost Estimate

The preparation of two TEAs per year will cost approximately $171,300 annually (using
a 2017 wage rate of $56.17 multiplied by the total number of burden hours associated with
submissions [3,050 hours]). Similarly we calculated that preparation of safety and effectiveness
data in support of TEA ingredients will cost approximately $264,000 per year ($56.17 per hour

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times 4,700 hours). Thus, we estimate a total annualized cost of $435,300 per year ($171,300
plus $264,000).
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
Costs to the Federal Government related to the collection of information have been absorbed
through existing resource allocations.
15. Explanation for Program Changes or Adjustments
The information collection reflects an additional 6 hours of burden and 5 annual responses. By
final rule of November 23, 2016 (81 FR 84465), FDA revised the TEA regulations to establish
timelines and performance metrics for review of non-sunscreen TEAs, and safety and
effectiveness data submissions, as required by the Sunscreen Innovation Act. We itemized these
regulations and the corresponding burden estimate in both our 60-day and 30-day notices, and in
Q12. of this supporting statement. We have consolidated, however, the individual provisions as
they appear to the reader at www.reginfo.gov.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans for tabulation and publication and project time scheduled.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed as required.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.