Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).
Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD–560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–2222.
In the
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Shortly after FDA issued the FM, an industry national trade association submitted a petition (“The petition,” Ref. 1) requesting FDA to amend the FM to permit the terms “helps prevent” and “chafed” in the indications in § 347.50(b)(2). The petition stated that FDA had included these terms in the indication in this section proposed in the tentative final monograph (TFM) (February 15, 1983, 48 FR 6820 at 6832), which stated: “Helps prevent and temporarily protects chafed, chapped, cracked, or windburned skin and lips.”
The petition noted that the preamble to the FM contained a discussion of a study using nonmonograph concentrations of glycerin (less than 20 percent) that were found to be inadequate to support the indication that had been proposed in the TFM (see 68 FR 33362 at 33367). The petition added that the FM did not provide adequate justification or discussion for the elimination of this claim for other skin protectant active ingredients. The petition stated that skin protectant products are selected frequently for their preventative as well as their protective benefits. The petition requested FDA to reconsider its decision not to include the terms “helps prevent” and “chafed” in the indications in § 347.50(b)(2) of the FM.
FDA has reevaluated the indications in § 347.50(b)(2) of the FM and concurs with the petition that these terms should have remained in these indications, as proposed in the TFM. However, because labeling space may be limited for some OTC skin protectant drug products and all manufacturers of these products may not wish to include this additional language in their products' indications, FDA is including these additional terms as optional labeling in the indications in § 347.50(b)(2). Including these additional terms as labeling options will enable those manufacturers who wish to include these terms in product labeling to do so, but will not require all manufacturers of these products to have to include the terms if they do not wish to do so. Accordingly, in this final rule, FDA is amending § 347.50(b)(2) to read as follows:
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FDA concludes that this revised labeling provides manufacturers a number of ways to state the indications for these OTC skin protectant drug
(e)(1)(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.
(f)(1)(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to “Use [in bold type] helps protect minor cuts and burns” or “Use [in bold type] helps” (optional: “prevent and”) “protect chapped skin” or “Use [in bold type] helps protect minor cuts and burns and” (optional: “prevent and protect”) “chapped skin”.
FDA also intends to amend one of the indications in § 352.52(f)(1)(ii) to add the optional “prevents” language to be comparable to the other labeling revisions being made above. FDA intends to propose that the revised indication state:
“For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and” (optional: “prevent and protect”) “chapped lips”.
To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that obtaining public comment is impracticable, unnecessary, and contrary to public interest. The labeling revisions represent a minor change to reinstate language that should not have been excluded from the FM, and to make other labeling in the FM consistent with the labeling proposed in the TFM. In addition, given the imminence of the current compliance dates (see DATES) for the FM, seeking prior public comment on this delay is contrary to the public interest in the orderly issuance and implementation of regulations. In accordance with 21 CFR 10.40(e)(1), FDA is providing an opportunity for comment on whether the regulation should be modified or revoked.
FDA has examined the impacts of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
FDA concludes that this final rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. The final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.
The purpose of this final rule is to revise several monograph indications. These changes provide manufacturers of OTC skin protectant drug products additional options to state the uses in the labeling for their products.
All manufacturers of OTC skin protectant drug products will need to relabel their products as a result of the FM issued on June 4, 2003. Based on the amount of time it takes to relabel products (6 to 10 months, on average) FDA estimates that few, if any, manufacturers have relabeled their products as of the date of this technical amendment to the FM.
For the reasons stated in the previous paragraphs and under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commissioner of Food and Drugs certifies that this final rule will not have a significant economic impact on a substantial number of small entities.
FDA concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, FDA has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Interested persons may submit written or electronic comments to the Division of Dockets Management (see
The following reference is on display in the Division of Dockets Management (see
1. Comment No. PRC1.
Labeling, Over-the-counter drugs.
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
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(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps” (optional: “prevent and”) “protect” (optional: “and relieve”) “chapped lips”. If both optional terms are used, the indication may be limited to: “Use [in bold type] helps prevent, protect, and relieve chapped lips”.
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(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to “Use [in bold type] helps protect minor cuts and burns” or “Use [in bold type] helps” (optional: “prevent and”) “protect chapped skin” or “Use [in bold type] helps protect minor cuts and burns and” (optional: “prevent and protect”) “chapped skin”.