2010-13279. Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.

DATES:

Submit either electronic or written comments on the collection of information by August 2, 2010.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Format and Content Requirements for OTC Drug Product Labeling (OMB Control Number 0910 0340)—Reinstatement

In the Federal Register of March 17, 1999 (64 FR 13254), we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products in part 201 (21 CFR part 201) (the 1999 labeling final rule). The regulations in part 201 require OTC drug product labeling to include uniform headings and 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 to part 201. 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 OTC sunscreen products and new OTC drug products introduced to the marketplace under new drug applications (NDAs) or abbreviated new drug applications (ANDAs). All OTC drug products except sunscreens and new OTC products marketed under NDAs or ANDAs are already required to be in compliance with these labeling regulations. 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 on 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. Because the compliance date has passed for all OTC drug products except sunscreens and drug products introduced under new NDAs or ANDAs, we believe that the labeling burden associated with the 1999 labeling final rule applies only to these products. We do not anticipate receiving any requests for exemptions or deferrals under § 201.66(e) because we have only received one request in the past 8 years.

We estimate that there are 4,750 OTC sunscreen drug product stock keeping units (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 the 1999 sunscreen final rule when it is published in the Federal Register. We estimate that these 4,750 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 4,750 sunscreen SKUs, the total number of hours dedicated to the labeling of sunscreen products would be 9,500 hours (4,750 SKUs times 2 hours/SKU) (see table 1 of this document).

Based on estimates provided by the Consumer Healthcare Products Association, we believe that approximately 500 new OTC drug product SKUs marketed under NDAs or ANDAs are introduced to the marketplace each year. We estimate that these SKUs are marketed by 300 manufacturers. We estimate that the preparation of labeling for new NDAs and ANDAs will require 5 hours to prepare, complete, and review new labeling prior to submitting the new labeling to us. Based on this estimate, the annual reporting burden for this type of labeling is approximately 2,500 hours (see table 1 of this document).

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
201.66(c) and (d)2	400	11.88	4,750	2	9,500
201.66(c) and (d)3	300	1.67	500	5	2,500
Total					12,000
1 FDA estimates 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 product.
3 Burden for manufacturers of products marketed under new NDAs or ANDAs.

Dated: May 27, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.