Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 38975 [C1-2011-14766]
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Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Rules and Regulations
the request in an electronic format and
requesting an alternative format. Such
request must include an explanation of
why an alternative format is necessary.
All submissions, including requests to
submit the information in an alternative
format, requests for exemptions, and all
supporting information must be legible
and in the English language. An
exemption request must contain:
(1) The manufacturer’s address and
contact information;
(2) Identification of the tobacco
product(s);
(3) A detailed explanation of the
purpose of the modification;
(4) A detailed description of the
modification, including a statement as
to whether the modification involves
adding or deleting a tobacco additive, or
increasing or decreasing the quantity of
an existing tobacco additive;
(5) A detailed explanation of why the
modification is a minor modification of
a tobacco product that can be sold under
the Federal Food, Drug, and Cosmetic
Act;
(6) A detailed explanation of why a
report under section 905(j)(1) of the
Federal Food, Drug, and Cosmetic Act
intended to demonstrate substantial
equivalence is not necessary to ensure
that permitting the tobacco product to
be marketed would be appropriate for
protection of the public health;
(7) A certification (i.e., a signed
statement by a responsible official of the
manufacturer) summarizing the
supporting evidence and providing the
rationale for the official’s determination
that the modification does not increase
the tobacco product’s appeal to or use
by minors, toxicity, addictiveness, or
abuse liability;
(8) Other information justifying an
exemption; and
(9) An environmental assessment
under part 25 of this chapter prepared
in accordance with the requirements of
§ 25.40 of this chapter.
(c) Exemption determination. FDA
will review the information submitted
and determine whether to grant or deny
an exemption request based on whether
the criteria in section 905(j)(3) of the
Federal Food, Drug, and Cosmetic Act
are met. FDA may request additional
information if necessary to make a
determination. FDA will consider the
exemption request withdrawn if the
information is not provided within the
requested timeframe.
(d) Rescission of an exemption. FDA
may rescind an exemption if it finds
that the exemption is not appropriate for
the protection of public health. In
general, FDA will rescind an exemption
only after notice and opportunity for a
hearing under part 16 of this chapter is
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provided. However, FDA may rescind
an exemption prior to notice and
opportunity for a hearing under part 16
of this chapter if the continuance of the
exemption presents a serious risk to
public health. In that case, FDA will
provide the manufacturer an
opportunity for a hearing as soon as
possible after the rescission.
Subpart B—[Reserved]
Dated: June 29, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16766 Filed 7–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 201
[Docket No. FDA–1978–N–0018] (formerly
Docket No. 1978N–0038)
RIN 0910–AF43
Labeling and Effectiveness Testing;
Sunscreen Drug Products for Over-theCounter Human Use
Correction
In rule document 2011–14766
appearing on pages 35620–35665 in the
issue of Friday, June 17, 2011, make the
following correction:
§ 201.327
[Corrected]
In § 201.327, on page 35661, in the
third column, § 201.327(i)(1)(ii)(A)(2)
and (3) should read as follows:
(2) Vi (λ) = 100.094 * (298-λ) (298 < λ ≤
328 nm)
(3) Vi (λ) = 100.015 * (140-λ) (328 < λ ≤
400 nm)
[FR Doc. C1–2011–14766 Filed 7–1–11; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2011–0198]
RIN 1625–AA00
Safety Zone; Upper Mississippi River,
Mile 856.0 to 855.0, Minneapolis, MN
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone for
SUMMARY:
PO 00000
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Fmt 4700
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38975
all waters of the Upper Mississippi
River, from Mile 856.0 to 855.0,
Minneapolis, Minnesota, and extending
the entire width of the river. This safety
zone is needed to protect participants
and event personnel during the U.S.
Wakeboard Nationals occurring on the
Upper Mississippi River. Entry into this
zone is prohibited unless specifically
authorized by the Captain of the Port
Upper Mississippi River or a designated
representative during the period of
enforcement.
DATES: This rule is effective from 8 a.m.
on July 20, 2011 through 6 p.m. CDT on
July 24, 2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2011–
0198 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–0198 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ They
are also available for inspection or
copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call or e-mail Chief Petty Officer
Bryan Klostermeyer, Sector Upper
Mississippi River Response Department
at telephone (314) 269–2566, e-mail
Bryan.K.Klostermeyer@uscg.mil. If you
have questions on viewing the docket,
call Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’
Under 5 U.S.C. 553(b)(B), the Coast
Guard finds that good cause exists for
not using the notice of proposed
rulemaking (NPRM) process. The Coast
Guard received notice of the U.S.
Wakeboard Nationals event on May 11,
2011. This short notice did not allow
the time needed to publish a NPRM and
provide a comment period. Delaying
this rule by publishing a NPRM would
be impracticable because this rule is
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]]>Agencies
[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Rules and Regulations]
[Page 38975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: C1-2011-14766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 201
[Docket No. FDA-1978-N-0018] (formerly Docket No. 1978N-0038)
RIN 0910-AF43
Labeling and Effectiveness Testing; Sunscreen Drug Products for
Over-the-Counter Human Use
Correction
In rule document 2011-14766 appearing on pages 35620-35665 in the
issue of Friday, June 17, 2011, make the following correction:
Sec. 201.327 [Corrected]
In Sec. 201.327, on page 35661, in the third column, Sec.
201.327(i)(1)(ii)(A)(2) and (3) should read as follows:
(2) Vi ([lambda]) = 10\0.094\ * (\298\-
[lgr]) (298 < [lgr] <= 328 nm)
(3) Vi ([lambda]) = 10\0.015\ * (\140\-
[lgr]) (328 < [lgr] <= 400 nm)
[FR Doc. C1-2011-14766 Filed 7-1-11; 8:45 am]
BILLING CODE 1505-01-D
