Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Reopening of the Comment Period, 16973-16974 [2012-6948]
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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules
heading of this document and they 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.
List of Subjects in 21 CFR Part 20
Confidential business information,
Courts, Freedom of information,
Government employees.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 20 be amended as follows:
Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6969 Filed 3–22–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 202
[Docket No. FDA–2009–N–0582]
RIN 0910–AG27
1. The authority citation for 21 CFR
part 20 continues to read as follows:
Authority: 5 U.S.C. 552; 18 U.S.C. 1905;
19 U.S.C. 2531–2582; 21 U.S.C. 321–393,
1401–1403; 42 U.S.C. 241, 242, 242a, 242l,
242n, 243, 262, 263, 263b–263n, 264, 265,
300u–300u–5, 300aa–1.
Direct-to-Consumer Prescription Drug
Advertisements; Presentation of the
Major Statement in Television and
Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner;
Reopening of the Comment Period
AGENCY:
PART 20—PUBLIC INFORMATION
2. Amend section 20.108 as follows:
a. Revise paragraph (b);
b. Remove paragraph (c);
c. Redesignate paragraph (d) as
paragraph (c);
d. Revise newly redesignated
paragraph (c).
The revisions and redesignations read
as follows:
§ 20.108 Agreements between the Food
and Drug Administration and other
departments, Agencies, and organizations.
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
*
*
*
*
*
(b) All written agreements and
memoranda of understanding between
FDA and any entity, including, but not
limited to other departments, Agencies,
and organizations will be made
available through the Food and Drug
Administration Web site at https://www.
fda.gov once finalized.
(c) Agreements and understandings
signed by officials of the Food and Drug
Administration with respect to activities
of the Office of Criminal Investigations
are exempt from the requirements set
forth in paragraph (b) of this section.
Although such agreements and
understandings will not be made
available through the Food and Drug
Administration Web site, these
agreements will be available for
disclosure in response to a request from
the public after deletion of information
that would disclose confidential
investigative techniques or procedures,
or information that would disclose
guidelines for law enforcement
investigations if such disclosure could
reasonably be expected to risk
circumvention of the law.
VerDate Mar<15>2010
17:08 Mar 22, 2012
Jkt 226001
Food and Drug Administration,
HHS.
Proposed rule; reopening of
comment period on specific data.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period on specific data related
to a proposed rule published in the
Federal Register of March 29,, to
establish standards that would be
considered in determining whether the
major statement in direct-to-consumer
(DTC) television and radio
advertisements relating to the side
effects and contraindications of an
advertised prescription drug intended
for use by humans is presented in a
clear, conspicuous, and neutral manner.
In the Federal Register of January 27,
2012, FDA announced that it had added
a document to the docket for the
proposed rulemaking concerning a
study entitled ‘‘Experimental Evaluation
of the Impact of Distraction on
Consumer Understanding of Risk and
Benefit Information in Direct-toConsumer Prescription Drug Television
Advertisements’’ (Distraction Study)
and the public was given until February
27, 2012, to comment on this study as
it relates to the proposed standards.
FDA is reopening the comment period
for the rulemaking proceeding in
response to a request for more time to
submit comments to the Agency.
DATES: Submit either electronic or
written comments on the Distraction
Study report as it relates to the proposed
standards by April 9, 2012.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0582 and/or Regulatory Information
Number (RIN) 0910–AG27, by any of the
following methods.
SUMMARY:
PO 00000
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Fmt 4702
Sfmt 4702
16973
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (For
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name, docket
number, and RIN for this rulemaking.
All comments received may be posted
without change to https://www.
regulations.gov, including any personal
information provided. For additional
information on submitting comments,
see the ‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://www.
regulations.gov and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
For information concerning human
drug products: Ernest S. Voyard, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3276,
Silver Spring, MD 20993–0002, 301–
796–3832.
For information concerning human
biological drug products: Stephen
Ripley, Center for Biologics Evaluation
and Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 29,
2010 (75 FR 15376), FDA published a
proposed rule entitled ‘‘Direct-toConsumer Prescription Drug
Advertisements; Presentation of the
Major Statement in Television and
Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner,’’ to
amend its regulations concerning DTC
advertisements of prescription drugs.
Specifically, the proposed rule would
implement a new requirement of the
E:\FR\FM\23MRP1.SGM
23MRP1
16974
Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), added by section
901(d)(3)(A) of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) (FDAAA). This
section requires that the major statement
in DTC television or radio
advertisements relating to the side
effects and contraindications of an
advertised prescription drug intended
for use by humans be presented in a
clear, conspicuous, and neutral manner,
and directs FDA to publish regulations
establishing the standards for
determining whether a major statement
meets these requirements. As directed
by section 901(d)(3)(B) of FDAAA, the
proposed rule described standards that
the Agency would consider in
determining whether the major
statement is clear, conspicuous, and
neutral, and it provided a 90-day period
for public comment, which closed on
June 28, 2010.
On January 27, 2012 (77 FR 4273),
FDA reopened the comment period on
this rulemaking until February 27, 2012,
to allow an opportunity for interested
parties to comment on FDA’s analyses
of the results of its study (see
attachment in Docket No. FDA–2009–
N–0582–0040) on the impact of
distraction on consumer understanding
of risk and benefit information in DTC
prescription drug television
advertisements (72 FR 47051, August
22, 2007) (Distraction Study) as it relates
to the proposed standards. The
Pharmaceutical Research and
Manufacturers of America (PhRMA)
submitted a letter dated February 20,
2012, requesting an additional 15 days
for interested persons to comment. FDA
believes that an additional 15 days to
comment on the Distraction Study as it
relates to the proposed standards is
appropriate.
TKELLEY on DSK3SPTVN1PROD with PROPOSALS
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the Distraction
Study as it relates to the proposed
standards. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document and label them ‘‘ATTN:
Distraction Study.’’ The data and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
VerDate Mar<15>2010
17:08 Mar 22, 2012
Jkt 226001
Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6948 Filed 3–22–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 100
[Docket No. USCG–2012–0073]
RIN 1625–AA08
Special Local Regulations; Ocean
State Tall Ships Festival 2012,
Narragansett Bay, RI
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
establish temporary special local
regulations on the navigable waters of
Narragansett Bay and Newport Harbor,
Rhode Island, for the Ocean State Tall
Ships Festival 2012. This action is
necessary to provide for the safety of life
and property on the navigable waters of
Narragansett Bay and Newport Harbor,
Rhode Island, during the Ocean State
Tall Ships Festival on July 6–9, 2012.
These temporary special local
regulations would restrict vessel traffic
in portions of Narragansett Bay and
Newport Harbor, Rhode Island, unless
authorized by the Captain of the Port
(COTP) Sector Southeastern New
England.
SUMMARY:
Comments and related material
must be received by the Coast Guard on
or before May 22, 2012. Requests for
public meetings must be received by the
Coast Guard on or before April 13, 2012.
ADDRESSES: You may submit comments
identified by docket number USCG–
2012–0073 using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail or Delivery: Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001. Deliveries
accepted between 9 a.m. and 5 p.m.,
Monday through Friday, except federal
holidays. The telephone number is 202–
366–9329. See the ‘‘Public Participation
and Request for Comments’’ portion of
the SUPPLEMENTARY INFORMATION section
below for further instructions on
submitting comments. To avoid
DATES:
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Fmt 4702
Sfmt 4702
duplication, please use only one of
these three methods.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this proposed
rule, call or email Mr. Edward G.
LeBlanc, Waterways Management
Division at Coast Guard Sector
Southeastern New England, telephone
401–435–2351, email
Edward.G.LeBlanc@uscg.mil. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking (USCG–2012–0073),
indicate the specific section of this
document to which each comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online (via https://
www.regulations.gov) or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online via https://
www.regulations.gov, it will be
considered received by the Coast Guard
when you successfully transmit the
comment. If you fax, hand deliver, or
mail your comment, it will be
considered as having been received by
the Coast Guard when it is received at
the Docket Management Facility. We
recommend that you include your name
and a mailing address, an email address,
or a telephone number in the body of
your document so that we can contact
you if we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, type the
docket number (USCG–2012–0073 in
the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on ‘‘Submit a
Comment’’ on the line associated with
this rulemaking.
If you submit your comments by mail
or hand delivery, submit them in an
unbound format, no larger than 81⁄2 by
11 inches, suitable for copying and
electronic filing. If you submit
comments by mail and would like to
E:\FR\FM\23MRP1.SGM
23MRP1
Agencies
[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16973-16974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6948]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 202
[Docket No. FDA-2009-N-0582]
RIN 0910-AG27
Direct-to-Consumer Prescription Drug Advertisements; Presentation
of the Major Statement in Television and Radio Advertisements in a
Clear, Conspicuous, and Neutral Manner; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of comment period on specific data.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period on specific data related to a proposed rule published in
the Federal Register of March 29,, to establish standards that would be
considered in determining whether the major statement in direct-to-
consumer (DTC) television and radio advertisements relating to the side
effects and contraindications of an advertised prescription drug
intended for use by humans is presented in a clear, conspicuous, and
neutral manner. In the Federal Register of January 27, 2012, FDA
announced that it had added a document to the docket for the proposed
rulemaking concerning a study entitled ``Experimental Evaluation of the
Impact of Distraction on Consumer Understanding of Risk and Benefit
Information in Direct-to-Consumer Prescription Drug Television
Advertisements'' (Distraction Study) and the public was given until
February 27, 2012, to comment on this study as it relates to the
proposed standards. FDA is reopening the comment period for the
rulemaking proceeding in response to a request for more time to submit
comments to the Agency.
DATES: Submit either electronic or written comments on the Distraction
Study report as it relates to the proposed standards by April 9, 2012.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0582 and/or Regulatory Information Number (RIN) 0910-AG27, by any of
the following methods.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency
name, docket number, and RIN for this rulemaking. All comments received
may be posted without change to https://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
For information concerning human drug products: Ernest S. Voyard,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, rm. 3276, Silver Spring, MD 20993-
0002, 301-796-3832.
For information concerning human biological drug products: Stephen
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 29, 2010 (75 FR 15376), FDA
published a proposed rule entitled ``Direct-to-Consumer Prescription
Drug Advertisements; Presentation of the Major Statement in Television
and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner,''
to amend its regulations concerning DTC advertisements of prescription
drugs. Specifically, the proposed rule would implement a new
requirement of the
[[Page 16974]]
Federal Food, Drug, and Cosmetic Act (the FD&C Act), added by section
901(d)(3)(A) of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) (FDAAA). This section requires that the major
statement in DTC television or radio advertisements relating to the
side effects and contraindications of an advertised prescription drug
intended for use by humans be presented in a clear, conspicuous, and
neutral manner, and directs FDA to publish regulations establishing the
standards for determining whether a major statement meets these
requirements. As directed by section 901(d)(3)(B) of FDAAA, the
proposed rule described standards that the Agency would consider in
determining whether the major statement is clear, conspicuous, and
neutral, and it provided a 90-day period for public comment, which
closed on June 28, 2010.
On January 27, 2012 (77 FR 4273), FDA reopened the comment period
on this rulemaking until February 27, 2012, to allow an opportunity for
interested parties to comment on FDA's analyses of the results of its
study (see attachment in Docket No. FDA-2009-N-0582-0040) on the impact
of distraction on consumer understanding of risk and benefit
information in DTC prescription drug television advertisements (72 FR
47051, August 22, 2007) (Distraction Study) as it relates to the
proposed standards. The Pharmaceutical Research and Manufacturers of
America (PhRMA) submitted a letter dated February 20, 2012, requesting
an additional 15 days for interested persons to comment. FDA believes
that an additional 15 days to comment on the Distraction Study as it
relates to the proposed standards is appropriate.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
Distraction Study as it relates to the proposed standards. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document and
label them ``ATTN: Distraction Study.'' The data and received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6948 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P