[Federal Register Volume 69, Number 171 (Friday, September 3, 2004)]
[Rules and Regulations]
[Pages 53801-53804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket Nos. 1998N-0337, 1996N-0420, 1995N-0259, and 1990P-0201]
RIN 0910-AA79


Over-the-Counter Human Drugs; Labeling Requirements; Delay of 
Implementation Date

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; delay of implementation date of certain 
provisions.

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SUMMARY:  The Food and Drug Administration (FDA) is providing a delay 
of the implementation date for certain products subject to its final 
rule that established standardized format and content requirements for 
the labeling of over-the-counter (OTC) drug products (drug facts rule). 
That final rule requires all OTC drug products to comply with new 
format and labeling requirements within prescribed implementation 
periods. The agency intends in a future issue of the Federal Register 
to propose an amendment to the drug facts rule to modify the labeling 
requirements for OTC sunscreen drug products. This document postpones 
the implementation date of the drug facts rule as it applies to OTC 
sunscreen drug products pending the outcome of the future rulemaking.

DATES:  Effective: October 4, 2004. FDA is delaying the May 16, 2005, 
implementation date for the drug facts rule (21 CFR 201.66) as it 
applies to OTC sunscreen drug products (21 CFR part 352) until further 
notice.
    Comment Date: Submit written or electronic comments by December 2, 
2004.

ADDRESSES:  You may submit comments, identified by Docket Nos. 1998N-
0337, 1996N-0420, 1995N-0259, and 1990P-0201 and/or RIN number 0910-
AA79, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/docket/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket Nos. 1998N-
0337, 1996N-0420, 1995N-0259, and 1990P-0201 and/or RIN number 0910-
AA79 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket numbers or regulatory information number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the dockets to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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, 301-827-2307.

[[Page 53802]]


SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing standardized format and 
standardized content requirements for the labeling of OTC drug products 
(drug facts rule). Those requirements are codified in Sec.  201.66.
    Section 201.66(a) states that the content and format requirements 
in Sec.  201.66 apply to the labeling of all OTC drug products. In the 
drug facts rule and in subsequent documents, FDA provided different 
dates by which OTC drug products had to comply with the new 
requirements. These dates varied according to the regulatory status of 
the products (64 FR 13254 at 13273 and 13274).

A. Compliance Dates for the Drug Facts Rule

1. Products in the OTC Drug Review
    Products for which a final monograph (FM) became effective on or 
after April 16, 1999, had to comply ``as of: (1) The applicable 
implementation date for that final monograph, (2) the next major 
revision to any part of the label or labeling after April 16, 2001, or 
(3) April 18, 2005, whichever occurs first.'' Combination drug products 
in which one or more active ingredients were the subject of an FM, and 
one or more ingredients were still under review as of the effective 
date of the drug facts rule, had to comply as of the implementation 
date for the last applicable FM for the combination, or as of April 16, 
2001, whichever occurred first. Combination products in which none of 
the active ingredients was the subject of an FM or monographs as of the 
effective date of the drug facts rule had to comply ``as of: (1) The 
implementation date of the last applicable final monograph for the 
combination, (2) the next major revision to any part of the label or 
labeling after April 16, 2001, or (3) April 18, 2005, whichever comes 
first.''
2. Products Marketed Under NDAs and ANDAs
    Products that were the subject of a drug application (NDA or ANDA) 
that was approved before April 16, 1999, had to comply with the drug 
facts rule as of April 16, 2001. Products that became the subject of an 
approved NDA or ANDA on or after April 16, 1999, were required to 
comply with the drug facts rule at the time of approval (64 FR 13254 at 
13274).
3. Additional Provisions
    In addition, any OTC drug product not described in sections I.A.1 
and I.A.2 of this document had to comply with the drug facts rule ``as 
of: (1) The next major revision to any part of the label or labeling 
after April 16, 2001, or (2) April 18, 2005, whichever occurs first.''

B. Correction Document

    In the Federal Register of April 15, 1999 (64 FR 18571), FDA 
published a correction to the drug facts rule and changed its effective 
date from April 16, 1999, to May 16, 1999. While FDA did not explicitly 
discuss the implementation plan and compliance dates for the drug facts 
rule, the correction had the effect of changing the compliance dates 
for the drug facts rule as follows: (1) The April 16, 1999, compliance 
date became May 16, 1999; (2) the April 16, 2001, compliance date 
became May 16, 2001; and (3) the April 18, 2005, compliance date became 
May 16, 2005.

C. Partial Extension

    In the Federal Register of June 20, 2000 (65 FR 38191), FDA 
published a partial extension of compliance dates for the drug facts 
rule. FDA extended the May 16, 2001, date to May 16, 2002 (and the 
corresponding May 16, 2002, date for products with annual sales of less 
than $25,000 to May 16, 2003). The May 16, 2005, date was not changed. 
FDA did not extend the date for products marketed under an NDA or ANDA 
approved after May 16, 1999. FDA also made one minor change in the 
implementation chart that appeared in the drug facts rule (64 FR 13254 
at 13274). That change involved combination products subject to an OTC 
drug monograph or monographs in which at least one applicable monograph 
was finalized before May 16, 1999, and at least one applicable 
monograph was finalized on or after May 16, 1999. The final rule had 
stated the compliance date for such products as ``Within the period 
specified in the last applicable monograph to be finalized, or by May 
16, 2002 (or by May 16, 2003, if annual sales of the product are less 
than $25,000), whichever occurs first.'' FDA recognized that some final 
monographs may be finalized close to the May 16, 2002, date. If that 
occurred, relabeling might be required at two closely related time 
intervals by two different final rules. FDA added that it would be 
aware of that possibility when the last applicable monograph is 
published and would make allowance there to avoid this dual relabeling 
within a short time period. Therefore, at the end of the time period 
for this specific type of combination product in the implementation 
chart, FDA added the words ``unless the last applicable monograph to be 
finalized specifies a later date.'' The restated implementation chart 
can be found at 65 FR 38191 at 38193. FDA concluded that this 
additional language should alleviate any possible ambiguities that 
might have existed about when relabeling required by two different 
rules would have to occur. A similar concept applies to FDA's delay of 
the drug facts rule for OTC sunscreen drug products discussed in 
section III of this document.

II. Stay of the FM for OTC Sunscreen Drug Products

    In the Federal Register of May 21, 1999 (64 FR 27666), FDA 
published the FM for OTC sunscreen drug products in part 352. In the 
Federal Register of December 31, 2001 (66 FR 67485), FDA stayed that 
final rule until further notice. FDA issued that partial stay because 
it intends to propose amendments to part 352 that address both 
ultraviolet A and ultraviolet B radiation protection. FDA stated that 
because the agency has not yet published the proposed amendment to part 
352, it is not possible for manufacturers of OTC sunscreen drug 
products to relabel and test their products in accord with an amended 
FM by the, then current, effective date of December 31, 2002. 
Accordingly, FDA stayed part 352 until further notice could be provided 
in a future issue of the Federal Register. FDA added that it 
anticipated the new effective date would not be before January 1, 2005. 
The future document will contain proposed amendments to the drug facts 
labeling currently included in part 352 for OTC sunscreen drug 
products. At this time, FDA has not completed the proposed amendment of 
the sunscreen FM discussed in the December 31, 2001, stay.

III. FDA's Delay of the Drug Facts Rule for OTC Sunscreen Drug Products

    FDA has determined that a final amendment of the sunscreen FM will 
not be completed by the May 16, 2005, final implementation date for the 
OTC drug facts rule. FDA hopes to publish the final amendment of the 
sunscreen FM shortly after the May 16, 2005, implementation date. Thus, 
to avoid dual relabeling that might be required at two closely related 
time intervals by two different final rules, FDA believes the final 
implementation date for the OTC drug facts rule should also be 
concurrently delayed as it applies to OTC sunscreen drug products. For 
these reasons, FDA is delaying the May 16, 2005, implementation date 
for the drug facts rule as it applies to OTC sunscreen drug products 
until further notice. The

[[Page 53803]]

new implementation date for these products will be coordinated with the 
lifting of the stay for OTC sunscreen drug products covered by part 
352.
    The delay in the implementation date for OTC sunscreen drug 
products will remain in effect until FDA publishes an amended FM and 
provides a new compliance date or until FDA issues further notice. In 
either case, the delay enables manufacturers of these products to 
continue marketing them in their present labeling formats pending 
completion of the amended FM. The labeling of these products still 
needs to comply with the Federal Food, Drug, and Cosmetic Act (the act) 
and other applicable regulatory requirements. Notwithstanding this 
delay in the implementation date, manufacturers who wish to do so may 
still relabel the affected products in the drug facts format, 
particularly when existing labeling is exhausted and relabeling would 
occur in the normal course of business.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, FDA's 
implementation of this action without opportunity for public comment 
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 
the public interest. FDA is delaying the compliance date of Sec.  
201.66 for OTC sunscreen drug products because it intends to amend the 
FM for those products in the near future. That amendment will propose a 
new compliance date for those products to implement Sec.  201.66 and 
provide an opportunity to comment on this new date. In addition, given 
the imminence of the current implementation date, seeking prior public 
comment on this delay is contrary to the public interest in the orderly 
issuance and implementation of regulations. Notice and comment 
procedures in this instance would create uncertainty, confusion, and 
undue financial hardship because, during the time that FDA would be 
proposing to extend the implementation date for Sec.  201.66, those 
companies affected would have to be preparing to relabel to comply with 
the May 16, 2005, implementation date. In accordance with 21 CFR 
10.40(e)(1), FDA is providing an opportunity for comment on whether 
this delay should be modified or revoked.

IV. Delay of May 16, 2005, Implementation Date for Other OTC Drug 
Products

    FDA is not delaying the May 16, 2005, implementation date for the 
drug facts rule for any other OTC drug products in this document. In a 
restated implementation chart for the drug facts rule published in the 
Federal Register of April 5, 2002 (67 FR 16304 at 16306 to 16307), FDA 
stated different dates by which OTC single entity or combination drug 
products had to comply with the drug facts rule when OTC drug 
monographs were finalized after May 16, 1999. In all cases, the final 
implementation date was May 16, 2005, unless an FM specifies a 
different time period. At this time, no FM has specified a different 
time period. FDA intends that all OTC drug products comply with the May 
16, 2005, implementation date for the drug facts rule even if a final 
OTC drug monograph has not issued for a specific drug product class. 
The only other exceptions are as follows: (1) OTC sunscreen drug 
products discussed in this document and (2) OTC ``convenience-size'' 
drug products discussed in the April 5, 2002, partial delay of 
compliance dates for labeling requirements for OTC human drugs.

V. Analysis of Impacts

    The economic impact of the drug facts rule was discussed in the 
final rule (64 FR 13254 at 13276 to 13285). This partial delay of the 
May 16, 2005, implementation date for OTC sunscreen drug products 
provides additional time for companies to relabel certain products to 
comply with an amended FM, to be published in a future issue of the 
Federal Register. This delay will also reduce label obsolescence as 
companies will have additional time to use up more existing labeling. 
Thus, delaying the implementation date for these specific products will 
significantly reduce the economic impact of the final rule on 
manufacturers of these products.
    FDA has examined the impacts of this final rule (partial delay of 
the compliance date) under Executive Order 12866 and the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (Public Law 104-4). 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 has 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, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.''
    FDA concludes that this final rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
This 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. As discussed in this section, FDA has determined that this final 
rule will not have a significant economic impact on a substantial 
number of small entities. 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 meet or exceed $100 million adjusted for 
inflation. The current threshold after adjustment for inflation is 
about $110 million.
    The purpose of this final rule is to provide a partial delay of the 
May 16, 2005, implementation date by which manufacturers need to 
relabel their OTC sunscreen drug products. Accordingly, under the 
Regulatory Flexibility Act, FDA certifies that this final rule will not 
have a significant economic impact on a substantial number of small 
entities. No further analysis is required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. 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.

[[Page 53804]]

VIII. 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.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket numbers 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 between 9 a.m. and 4 p.m., Monday through Friday.

X. Authority

    This final rule (partial delay of compliance date) is issued under 
sections 201, 501, 502, 503, 505, 510, and 701 of the act (21 U.S.C. 
321, 351, 352, 353, 355, 360, and 371) and under authority of the 
Commissioner of Food and Drugs.

    Dated: July 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18842 Filed 9-2-04; 8:45 am]
BILLING CODE 4160-01-S