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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by September 13, 2010.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to All comments should be identified with the OMB control number 0910-0340. Also include the FDA docket number found in brackets in the heading of this document.

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Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792,

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Format and Content Requirements for Over-the-Counter Drug Product Labeling—OMB Control Number 0910-0340—Reinstatement

In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999 labeling final rule), we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed over-the-counter (OTC) drug products in part 201 (21 CFR part 201). The regulations in part 201 require OTC drug product labeling to include uniform headings Start Printed Page 49496and subheadings, presented in a standardized order, with minimum standards for type size and other graphical features. Specifically, the 1999 labeling final rule added new § 201.66. Section 201.66 sets content and format requirements for the Drug Facts portion of labels on OTC drug products.

The only burden to comply with the regulations in part 201 is a one-time burden for the following products:

  • New OTC drug products introduced to the marketplace under new drug applications (NDAs), abbreviated new drug applications (ANDAs), or an OTC drug monograph, except for products in “convenience size” packages1
  • OTC sunscreen products.

The burden is limited to these products because, as explained in this document, most currently marketed OTC drug products are already required to be in compliance with these labeling regulations, and thus will incur no further burden in order to satisfy this regulation. We recognize that some manufacturers may choose to modify labeling already required to be in Drug Facts format. We believe that such changes are usual and customary as part of routine redesign practice, and thus do not create additional burden within the meaning of the PRA. With the exceptions described, new products must comply with the regulations as they are introduced to the marketplace. Also, as explained in this document, OTC sunscreen products have not been required to comply with these regulations but are anticipated to become subject to these requirements when a sunscreen final rule becomes effective.

Specifically, on June 20, 2000 (65 FR 38191), we published a Federal Register document that required all OTC drug products marketed under the OTC monograph system except sunscreen products to comply with the regulations by May 16, 2005, or sooner (65 FR 38191 at 38193). Sunscreen products do not have to comply with the regulations until we lift the stay of the sunscreen final rule that was published in the Federal Register of May 21, 1999 (64 FR 27666) (the 1999 sunscreen final rule). In the Federal Register of December 31, 2001 (66 FR 67485), we stayed the 1999 sunscreen final rule indefinitely. In the Federal Register of September 3, 2004 (69 FR 53801), we delayed the § 201.66 implementation date for OTC sunscreen products indefinitely, pending future rulemaking to amend the substance of labeling for these products. In the Federal Register of August 27, 2007 (72 FR 49070), we proposed changes to labeling and related testing requirements for sunscreen products to address both ultraviolet A and ultraviolet B radiation, and anticipated that sunscreen products would become subject to § 201.66 at the time any resultant final rule becomes effective.

Based on a recent estimate provided by the Consumer Healthcare Products Association (CHPA),2 we believe that approximately 900 new OTC drug product stock keeping units (SKUs) are introduced to the marketplace each year. Further, we estimate that these SKUs are marketed by 300 manufacturers. We estimate that the preparation of labeling for new OTC drug products will require 5 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 approximately 4,500 hours. (See table 1 of this document.)

We estimate that there are 4,752 OTC sunscreen drug product SKUs that have not yet complied with the 1999 labeling final rule. All of these SKUs will need to implement the new labeling format by the implementation date included in a sunscreen final rule when it is published in the Federal Register. We estimate that these 4,752 SKUs are marketed by 400 manufacturers and that approximately 2 hours will be spent on each submission. (See table 1 of this document.) The number of hours per submission (response) is based on our estimate in the 1999 labeling final rule (64 FR 13254 at 13276). If an average of 2 hours is spent preparing, completing, and reviewing each of the estimated 4,752 sunscreen SKUs, the total number of hours dedicated to the labeling of OTC sunscreen products would be 9,504 hours (4,752 SKUs times 2 hours/SKU). (See table 1 of this document.)

In determining the burden for § 201.66, it is also important to consider exemptions or deferrals of the regulation allowed products under § 201.66(e). Since publication of the 1999 labeling final rule, we have received only one request for exemption or deferral. One response over an 8-year period equates to an annual frequency of response equal to 0.125. In the 1999 labeling final rule, we estimated that a request for deferral or exemption would require 24 hours to complete (64 FR 13254 at 13276). We continue to believe that this type of response will require approximately 24 hours. Multiplying the annual frequency of response (0.125) by the number of hour per response (24) gives a total response time for requesting exemption or deferral equal to 3 hours.

In the Federal Register of June 3, 2010 (75 FR 31448), we published a 60-day notice requesting public comment on the proposed collection of information. We received no comments.

We estimate the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
201.66(c) and (d)240011.884,75229,504
201.66(c) and (d)3300390054,500
1 We estimate that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with § 201.66. There are no operating or maintenance costs associated with this collection of information.
2 Burden for manufacturers of sunscreen drug products.
3 Burden for manufacturers of new OTC drug products.
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Dated: August 9, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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1.  In a final rule published in the Federal Register of April 5, 2002 (67 FR 16304), the agency delayed the compliance dates for the 1999 labeling final rule for all OTC drug products that: (1) Contain no more than two doses of an OTC drug; and (2) because of their limited available labeling space, would require more than 60 percent of the total surface area available to bear labeling to meet the requirements set forth in § 201.66(d)(1) and (d)(9) and, therefore, qualify for the labeling modifications currently set forth in § 201.66(d)(10) (67 FR 16304 at 16306). The agency issued this delay in order to develop additional rulemaking for these “convenience size” products (December 12, 2006, 71 FR 74474). These products are not currently subject to the requirements of § 201.66. PRA approval for any requirements to which they may be subject in the future will be handled in a separate rulemaking.

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2.  Letter submitted to FDA by CHPA on March 1, 2010 (available in Docket No. FDA-2010-N-0248).

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[FR Doc. 2010-19985 Filed 8-12-10; 8:45 am]