[Federal Register Volume 68, Number 236 (Tuesday, December 9, 2003)]
[Rules and Regulations]
[Pages 68509-68511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 347

[Docket Nos. 78N-0021 and 78N-021P]
RIN 0910-AA01


Skin Protectant Drug Products for Over-the-Counter Human Use; 
Final Monograph; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: 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).

DATES: Effective Date: This rule is effective June 4, 2004.
    Compliance Dates: The compliance date for products subject to part 
347 (21 CFR part 347) with annual sales less than $25,000 is June 6, 
2005. The compliance date for all other products subject to part 347 is 
June 4, 2004. The compliance date for combination products containing 
skin protectant and sunscreen active ingredients in Sec.  347.20(d) and 
for all products subject to part 352 was stayed until further notice at 
68 FR 33362, June 4, 2003.
    Comment Date: Submit written or electronic comments by February 9, 
2004.

ADDRESSES: 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 http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 4, 2003 (68 FR 33362), FDA issued a 
FM for OTC skin protectant drug products in part 347. Section 
347.50(b)(2) of that FM includes the following indications for OTC skin 
protectant drug products:
    (2) For products containing any ingredient in Sec.  347.10(a), 
(d), (e), (g), (h), (i), (k), (l), (m), and (r)--(i) The labeling 
states ``temporarily protects'' (which may be followed by: ``and 
helps relieve'') ``chapped or cracked skin'' (which may be followed 
by: ``and lips''). This statement may be followed by the optional 
statement: ``helps protect from the drying effects of wind and cold 
weather''. [If both statements are used, each is preceded by a 
bullet.]
    (ii) For products formulated as a lip protectant. The labeling 
states ``temporarily protects'' (which may be followed by: ``and 
helps relieve'') ``chapped or cracked lips''. This statement may be 
followed by the optional statement: ``helps protect lips from the 
drying effects of wind and cold weather''. [If both statements are 
used, each is preceded by a bullet.]
    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 Sec.  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 Sec.  347.50(b)(2) of the FM.

II. FDA's Conclusions on the Petition

    FDA has reevaluated the indications in Sec.  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 Sec.  
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 Sec.  347.50(b)(2) to 
read as follows:
    (2) For products containing any ingredient in Sec.  347.10(a), 
(d), (e), (g), (h), (i), (k), (l), (m), and (r)--(i) The labeling 
states (optional: ``helps prevent and'') ``temporarily protects'' 
(optional: ``and helps relieve'') (optional: ``chafed,'') ``chapped 
or cracked skin'' (optional: ``and lips''). This statement may be 
followed by the optional statement: ``helps'' (optional: ``prevent 
and'') ``protect from the drying effects of wind and cold weather''. 
[If both statements are used, each is preceded by a bullet.]
    (ii) For products formulated as a lip protectant. The labeling 
states (optional: ``helps prevent and'') ``temporarily protects'' 
(optional: ``and helps relieve'') (optional: ``chafed,'') ``chapped 
or cracked lips''. This statement may be followed by the optional 
statement: ``helps'' (optional: ``prevent and'') ``protect from the 
drying effects of wind and cold weather''. [If both statements are 
used, each is preceded by a bullet.]
    FDA concludes that this revised labeling provides manufacturers a 
number of ways to state the indications for these OTC skin protectant 
drug

[[Page 68510]]

products. Although not requested by the petition, FDA is also amending 
the indications in Sec.  347.50(e)(1)(ii) [for products formulated and 
labeled as a lip protectant and that meet the criteria established in 
Sec.  201.66(d)(10)] and (f)(1)(ii) [for products containing only cocoa 
butter, petrolatum, or white petrolatum, singly or in combination with 
each other, and marketed other than as a lip protectant]. FDA is 
amending these indications so that OTC skin protectant drug products 
labeled under these sections of the monograph can have comparable 
labeling to products labeled under Sec.  347.50(b)(2). These amended 
sections read as follows:
    (e)(1)(ii) The heading and the indication required by Sec.  
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 Sec.  
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 Sec.  
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 Sec.  201.66(c)(4) may be limited to: ``Use [in bold 
type] helps protect against sunburn and'' (optional: ``prevent and 
protect'') ``chapped lips''.
Because the final monograph for OTC sunscreen drug products in part 352 
is currently stayed, FDA intends to propose this revision in an 
amendment of that monograph, in a future issue of the Federal Register.
    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.

III. Analysis of Impacts

    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 et seq.). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Under the Regulatory 
Flexibility Act, if a rule may have a significant economic impact on a 
substantial number of small entities, an agency must analyze regulatory 
options that would minimize any significant impact of the rule on small 
entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 
requires that agencies prepare a written statement and economic 
analysis before proposing any rule that may result in an expenditure by 
state, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any 1 year (adjusted annually for 
inflation).
    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.

IV. Paperwork Reduction Act of 1995

    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 et seq.). Rather, the 
labeling statements are a ``public disclosure of information originally 
supplied by the Federal Government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

V. Federalism

    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.

VI. Environmental Impact

    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.

VII. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES). Three copies of all 
written comments are to be submitted. Individuals submitting written 
comments or anyone submitting electronic comments may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Division of 
Dockets Management

[[Page 68511]]

between 9 a.m. and 4 p.m., Monday through Friday.

VIII. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment No. PRC1.

List of Subjects in 21 CFR Part 347

    Labeling, Over-the-counter drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
347 is amended as follows:

PART 347--SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN 
USE

0
1. The authority citation for 21 CFR part 347 continues to read as 
follows:

    Authority: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 
371.

0
2. Section 347.50 is amended by revising paragraphs (b)(2), (e)(1)(ii), 
and (f)(1)(ii) to read as follows:


Sec.  347.50  Labeling of skin protectant drug products.

* * * * *
    (b) Indications. * * *
    (2) For products containing any ingredient in Sec.  347.10(a), (d), 
(e), (g), (h), (i), (k), (l), (m), and (r)--(i) The labeling states 
(optional: ``helps prevent and'') ``temporarily protects'' (optional: 
``and helps relieve'') (optional: ``chafed,'') ``chapped or cracked 
skin'' (optional: ``and lips''). This statement may be followed by the 
optional statement: ``helps'' (optional: ``prevent and'') ``protect 
from the drying effects of wind and cold weather''. [If both statements 
are used, each is preceded by a bullet.]
    (ii) For products formulated as a lip protectant. The labeling 
states (optional: ``helps prevent and'') ``temporarily protects'' 
(optional: ``and helps relieve'') (optional: ``chafed,'') ``chapped or 
cracked lips''. This statement may be followed by the optional 
statement: ``helps'' (optional: ``prevent and'') ``protect from the 
drying effects of wind and cold weather''. [If both statements are 
used, each is preceded by a bullet.]
* * * * *
    (e) Products formulated and labeled as a lip protectant and that 
meet the criteria established in Sec.  201.66(d)(10) of this chapter. * 
* *
    (1) * * *
    (ii) The heading and the indication required by Sec.  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) Products containing only cocoa butter, petrolatum, or white 
petrolatum identified in Sec.  347.10(d), (m), and (r), singly or in 
combination with each other, and marketed other than as a lip 
protectant. (1) * * *
    (ii) The heading and the indication required by Sec.  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''.
* * * * *

    Dated: December 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30394 Filed 12-8-03; 8:45 am]
BILLING CODE 4160-01-S