0340 OTC Drug Labeling SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Format and Content Requirements for
Over-the-Counter Drug Product Labeling
OMB Control No. 0910-0340
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. FDA’s legal authority to modify and simplify the manner in which certain
information is presented in over-the-counter (OTC) drug product labeling derives from sections
201, 502, 503, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Our
regulations at § 201.66 (21 CFR 201.66) establish standardized content and format requirements
for the labeling of all marketed OTC drug products. The regulations set forth specific content
and format requirements for the Drug Facts portion of labels on OTC drug products. The
regulations require OTC drug product labeling to include uniform headings and subheadings, and
be presented in a standardized order, with minimum standards for font size and other graphical
features. Currently marketed OTC drug products are required to comply with these labeling
requirements.
We consider labeling modifications requiring conformance with the Drug Facts format to be
“usual and customary” as part of routine redesign practice, such that any attendant information
collection activities do not create additional burden under the PRA. Therefore, this information
collection request supports burden necessary to comply with the labeling requirements in
§ 201.66 applicable to new OTC drug products and OTC sunscreen drug products introduced to
the marketplace under NDAs, ANDAs, or OTC drug monographs. New OTC drug products
must comply with the labeling requirements in § 201.66 as they are introduced to the
marketplace.
We therefore request extension of OMB approval for the information collection provisions found
in 21 CFR 201.66 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The labeling information required under § 201.66 is a one-time burden for manufacturers of new
OTC drug products introduced to the marketplace under new drug applications (NDAs),
abbreviated new drug applications (ANDAs), or OTC drug monographs. Manufacturers may
seek exemption or deferral from the requirements under § 201.66(e). However, we believe the
number seeking exemption or deferral will be extremely small, because we have received only
one such request in the last several years.

3. Use of Improved Information Technology and Burden Reduction
Currently, all listing information must be submitted electronically. Because labeling, including
Drug Facts, is included in drug listing, we expect that all respondents will use electronic means
to fulfill the requirements of § 201.66. We believe the use of electronic means substantially
reduces the burden associated with developing new labels. Currently available software and
hardware greatly simplify the process of creating, manipulating, and printing new labels.
4. Efforts to Identify Duplication and Use of Similar Information
The information included in the Drug Facts portion of labeling is unique for each drug product.
Similar drug products (i.e., in the same pharmacological category with the same dosage
strengths) will have very similar (but not necessarily identical) Drug Facts content and format.
We are unaware of duplicative information collection associated with the requirements in 21
CFR § 201.66.
5. Impact on Small Businesses or Other Small Entities
We do not believe the information collection imposes undue burden on small entities. Under the
regulations (§ 201.66(e)), respondents may request an exemption and/or deferral on the basis that
the requirement is inapplicable, impracticable, or contrary to public health or safety. We assist
small businesses in complying with our regulations through small business compliance resources
available from our website at www.fda.gov and through assistance from program staff within the
agency.
6. Consequences of Collecting the Information Less Frequently
We believe information collection under § 201.66 is a one-time burden for sunscreen
manufacturers and manufacturers of new OTC drug products introduced to the marketplace
under NDAs, ANDAs, or OTC drug monographs, and presents the minimal burden necessary for
ensuring the safety of these products.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances relating to this information collection.
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 June 19, 2019 (84 FR 28555). We received one comment that
encouraged the use of “provider-neutral language” in the Medication Guide regulations.
Because the comment did not pertain to the immediate information collection, or the associated
burden estimates provided in the 60-day notice, we have not addressed them here.

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9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided to respondent to the information collection.
10. Assurance of Respondent Privacy and Confidentiality
No personally identifiable information (PII) or other data of a personal nature is being collected.
The information collected is from sunscreen manufacturers and manufacturers of new over-thecounter (OTC) drug products introduced to the marketplace under new drug applications
(NDAs), abbreviated new drug applications (ANDAs), or OTC drug monographs regarding
standardized content and format requirements for the labeling of all marketed OTC drug
products. In preparing this supporting statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected and have determined that PII is not collected and
the Privacy Act of 1974 does not apply. Further, Drug Facts labeling developed under an OTC
monograph is not considered confidential. Industry interactions with FDA in the development of
labeling for new NDAs or ANDAs is classified as confidential under 21 U.S.C. 360j(c).
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 Estimate
Based on our electronic drug registration and listing database, we estimate that
approximately 7,858 new OTC drug product stock keeping units (SKUs) are introduced to the
marketplace each year, including sunscreen products. We estimate that these SKUs are marketed
by 855 manufacturers. We estimate that the preparation of labeling for new OTC drug products
requires 12 hours to prepare, complete, and review prior to submitting the new labeling to us.
Based on this estimate, the annual reporting burden for this type of labeling is 94,296 hours. All
currently marketed sunscreen products are also required to comply with the Drug Facts labeling
requirements in § 201.66, so they will incur no further burden under the information collection
provisions in the regulation. When determining the burden for § 201.66, it is also important to
consider exemptions or deferrals of the regulation allowed products under § 201.66(e). We
receive very few requests for exemption or deferral. We also estimate that a request for deferral
or exemption requires approximately 24 hours to complete.
Our estimate of the burden of this collection of information is as follows:

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Table 1.--Estimated Annual Third-Party Disclosure Burden1

21 CFR Section

§ 201.66(c) and (d) for
new OTC drug products
(including OTC
sunscreen products)
§ 201.66(e)
Total
1

Total
Annual
Disclosures
7,858

Average
Burden per
Disclosure
12

Total Hours

855

No. of
Disclosures per
Respondent
9.19

1

1

1

24

24
94,320

No. of
Respondents

94,296

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

12b. Annualized Cost Burden Estimate
We estimate one-time capital costs for manufacturers of products marketed under new
NDAs or ANDAs will be approximately $1.8 to $2.1 million for NDA and ANDA labels, and
therefore use an average of $1.95 million. We rely on previous figures for this estimate and
divide the total cost by the number of annual disclosures. Using this formula the cost per
disclosure is calculated to be $248.00 per disclosure.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital or start-up costs associated with the information collection. We estimate
any previous capital costs resulting from relabeling is now realized under the regulations.
14. Annualized Cost to the Federal Government
Review of information submitted to FDA under the collection is covered through existing
resource allocations.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. We have adjusted our estimate to reflect an
increase of 82,797 hours and a corresponding increase of 6,898 disclosures. The increase
corresponds with agency data on the number of labeling reviews associated with new OTC drug
product submissions. We have also included currently and past reported cost information so that
it will be reflected at www.reginfo.gov, and have combined two IC elements in our burden table.
We believe these changes will assist readers in understanding burden associated with the
information collection. Finally, although we include and discuss our burden figures in both the
supporting statement as well as our Federal Register notices, after publication we noted an
inadvertent error in the figures that were discussed in the narrative of the 30-day notice. We
have verified the figures reflected currently in our burden table and presented here in this
supporting statement, but regret this error.

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16. Plans for Tabulation and Publication and Project Time Schedule
There are no publications or other schedules.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification statement.

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