Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 23271-23273 [2013-09093]
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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
private organizations, and that have as their
primary purpose the operation of shelters for
victims of family violence, domestic
violence, and dating violence, and their
dependents or those which provide
counseling, advocacy, and self-help services
to victims of family violence, domestic
violence, and dating violence, and their
dependents (Section 10407(a)(2)(B)(iii)).
(4) Not less than 70 percent of the funds
distributed shall be for the primary purpose
of providing immediate shelter and
supportive services to adult and youth
victims of family violence, domestic
violence, or dating violence, and their
dependents (Section 10408(b)(2)).
(5) Not less than 25 percent of the funds
distributed shall be for the purpose of
providing supportive services and prevention
services as described in Section 10408(b)(2)to
victims of family violence, domestic
violence, or dating violence, and their
dependents).
(6) Not more than 5 percent of the funds
will be used for State administrative costs
(Section 10407(a)(2)(b)(i)).
(7) The State grantee is in compliance with
the statutory requirements of Section
10407(a)(2)(C), regarding the equitable
distribution of grants and grant funds within
the State and between urban and rural areas
within the State.
(8) The State will consult with and provide
for the participation of the State Domestic
Violence Coalition in the planning and
monitoring of the distribution of grant funds
and the administration of the grant programs
and projects (Section 10407(a)(2)(D)).
(9) Grant funds made available under this
program by the State will not be used as
direct payment to any victim of family
violence, domestic violence, or dating
violence, or to any dependent of such victim
(Section 10408(d)(1)).
(10) No income eligibility standard will be
imposed on individuals with respect to
eligibility for assistance or services supported
with funds appropriated to carry out the
FVPSA (Section 10406(c)(3)).
(11) No fees will be levied for assistance or
services provided with funds appropriated to
carry out the FVPSA (Section 10406(c)(3)).
(12) The address or location of any shelter
or facility assisted under the FVPSA that
otherwise maintains a confidential location
will, except with written authorization of the
person or persons responsible for the
operation of such shelter, not be made public
(Section 10406(c)(5)(H)).
(13) The applicant has established policies,
procedures, and protocols to ensure
compliance with the provisions of Section
10406(c)(5) regarding non-disclosure of
confidential or private information (Section
10407(a)(2)(A)).
(14) Pursuant to Section 10406(c)(5), the
applicant will comply with requirements to
ensure the non-disclosure of confidential or
private information, which include, but are
not limited to: (1) Grantees will not disclose
any personally identifying information
collected in connection with services
requested (including services utilized or
denied), through grantee’s funded activities
or reveal personally identifying information
without informed, written, reasonably time-
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limited consent by the person about whom
information is sought, whether for the
FVPSA-funded activities or any other Federal
or State program and in accordance with
Section 10406(c)(5)(B)(ii); (2) grantees will
not release information compelled by
statutory or court order unless adhering to
the requirements of Section10406(c)(5)(C); (3)
grantees may share non-personally
identifying information in the aggregate for
the purposes enunciated in Section
10406(c)(5)(D)(i) as well as for other purposes
found in Section 10406(c)(5)(D)(ii) and (iii).
(15) Grants funded by the State in whole
or in part with funds made available under
the FVPSA will prohibit discrimination on
the basis of age, disability, sex, race, color,
national origin, or religion (Section
10406(c)(2)).
(16) Funds made available under the
FVPSA will be used to supplement and not
supplant other Federal, State, and local
public funds expended to provide services
and activities that promote the objectives of
the FVPSA (Section 10406(c)(6)).
(17) Receipt of supportive services under
the FVPSA will be voluntary. No condition
will be applied for the receipt of emergency
shelter as described in Section 10408(d)(2)).
(18) The State grantee has a law or
procedure to bar an abuser from a shared
household or a household of the abused
person, which may include eviction laws or
procedures (Section 10407(a)(2)(H)).
lllllllllllllllllllll
Signature
lllllllllllllllllllll
Title
lllllllllllllllllllll
Organization
Appendix B
LGBTQ Accessibility Policy
As the Authorized Organizational
Representative (AOR) signing this
application on behalf of [Insert full, formal
name of applicant organization]
I hereby attest and certify that:
The needs of lesbian, gay, bisexual,
transgender, and questioning program
participants are taken into consideration in
applicant’s program design. Applicant
considered how its program will be inclusive
of and non-stigmatizing toward such
participants. If not already in place, awardee
and, if applicable, sub-awardees must
establish and publicize policies prohibiting
harassment based on race, sexual orientation,
gender, gender identity (or expression),
religion, and national origin. The submission
of an application for this funding opportunity
constitutes an assurance that applicants have
or will put such policies in place within 12
months of the award. Awardees should
ensure that all staff members are trained to
prevent and respond to harassment or
bullying in all forms during the award
period. Programs should be prepared to
monitor claims, address them seriously, and
document their corrective action(s) so all
participants are assured that programs are
safe, inclusive, and non-stigmatizing by
design and in operation. In addition, any subawardees or subcontractors:
PO 00000
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23271
• Have in place or will put into place
within 12 months of the award policies
prohibiting harassment based on race, sexual
orientation, gender, gender identity (or
expression), religion, and national origin;
• Will enforce these policies;
• Will ensure that all staff will be trained
during the award period on how to prevent
and respond to harassment or bullying in all
forms, and;
• Have or will have within 12 months of
the award, a plan to monitor claims, address
them seriously, and document their
corrective action(s).
Insert Date of Signature:
Print Name and Title of the AOR:
Signature of AOR:
[FR Doc. 2013–08711 Filed 4–17–13; 8:45 am]
BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0150]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection associated
with the guidance ‘‘Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims,’’
which is intended to assist applicants in
developing labeling for outcome claims
for drugs that are indicated to treat
hypertension.
DATES: Submit either electronic or
written comments on the collection of
information by June 17, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
SUMMARY:
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23272
Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
Administration, 5630 Fishers Lane., rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims—
(OMB Control Number 0910–0670)—
Extension
This guidance is intended to assist
applicants in developing labeling for
outcome claims for drugs that are
indicated to treat hypertension. With
few exceptions, current labeling for
antihypertensive drugs includes only
the information that these drugs are
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indicated to reduce blood pressure; the
labeling does not include information
on the clinical benefits related to
cardiovascular outcomes expected from
such blood pressure reduction.
However, blood pressure control is well
established as beneficial in preventing
serious cardiovascular events, and
inadequate treatment of hypertension is
acknowledged as a significant public
health problem. FDA believes that the
appropriate use of these drugs can be
encouraged by making the connection
between lower blood pressure and
improved cardiovascular outcomes
more explicit in labeling. The intent of
the guidance is to provide common
labeling for antihypertensive drugs
except where differences are clearly
supported by clinical data. The
guidance encourages applicants to
submit labeling supplements containing
the new language.
The guidance contains two provisions
that are subject to OMB review and
approval under the PRA, and one
provision that would be exempt from
OMB review:
(1) Section IV.C of the guidance
requests that the CLINICAL STUDIES
section of the Full Prescribing
Information of the labeling should
include a summary of placebo or activecontrolled trials showing evidence of
the specific drug’s effectiveness in
lowering blood pressure. If trials
demonstrating cardiovascular outcome
benefits exist, those trials also should be
summarized in this section. Table 1 in
Section V of the guidance contains the
specific drugs for which FDA has
concluded that such trials exist. If there
are no cardiovascular outcome data to
cite, one of the following two
paragraphs should appear:
‘‘There are no trials of [DRUGNAME] or
members of the [name of pharmacologic
class] pharmacologic class demonstrating
reductions in cardiovascular risk in patients
with hypertension,’’ or ‘‘There are no trials
of [DRUGNAME] demonstrating reductions
in cardiovascular risk in patients with
hypertension, but at least one
pharmacologically similar drug has
demonstrated such benefits.’’
In the latter case, the applicant’s
submission generally should refer to
table 1 in section V of the guidance. If
the applicant believes that table 1 is
incomplete, it should submit the
clinical evidence for the additional
information to Docket No. FDA–2008–
D–0150. The labeling submission
should reference the submission to the
docket. FDA estimates that no more
than one submission to the docket will
be made annually from one company,
and that each submission will take
approximately 10 hours to prepare and
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
submit. Concerning the
recommendations for the CLINICAL
STUDIES section of the Full Prescribing
Information of the labeling, FDA
regulations at §§ 201.56 and 201.57 (21
CFR 201.56 and 201.57) require such
labeling, and the information collection
associated with these regulations is
approved by OMB under OMB control
number 0910–0572.
(2) Section VI.B of the guidance
requests that the format of
cardiovascular outcome claim prior
approval supplements submitted to FDA
under the guidance should include the
following information:
1. A statement that the submission is
a cardiovascular outcome claim
supplement, with reference to the
guidance and related Docket No. FDA–
2008–D–0150.
2. Applicable FDA forms (e.g., 356h,
3397).
3. Detailed table of contents.
4. Revised labeling:
a. Include draft revised labeling
conforming to the requirements in
§§ 201.56 and 201.57;
b. Include marked-up copy of the
latest approved labeling, showing all
additions and deletions, with
annotations of where supporting data (if
applicable) are located in the
submission.
FDA estimates that approximately 20
cardiovascular outcome claim
supplements will be submitted annually
from approximately 8 different
companies, and that each supplement
will take approximately 20 hours to
prepare and submit. The guidance also
recommends that other labeling changes
(e.g., the addition of adverse event data)
should be minimized and provided in
separate supplements, and that the
revision of labeling to conform to
§§ 201.56 and 201.57 may require
substantial revision to the ADVERSE
REACTIONS or other labeling sections.
(3) Section VI.C of the guidance states
that applicants are encouraged to
include the following statement in
promotional materials for the drug.
’’[DRUGNAME] reduces blood pressure,
which reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and
myocardial infarctions. Control of high blood
pressure should be part of comprehensive
cardiovascular risk management, including,
as appropriate, lipid control, diabetes
management, antithrombotic therapy,
smoking cessation, exercise, and limited
sodium intake. Many patients will require
more than one drug to achieve blood pressure
goals.’’
The inclusion of this statement in the
promotional materials for the drug
would be exempt from OMB review
based on 5 CFR 1320.3(c)(2), which
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Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices
states that ‘‘The public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public
is not included * * *’’ within the
definition of ‘‘collection of
information.’’
FDA requests public comments on the
information collection provisions
described in this document and set forth
in the following table:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Submission to Docket Number FDA–2008–D–0150 ...........
Cardiovascular Outcome Claim Supplement Submission ...
1
8
1
2.5
1
20
10
20
10
400
Total ..............................................................................
........................
........................
........................
........................
410
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09093 Filed 4–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2001–P–0238, FDA–
2010–P–0526, FDA–2010–P–0540, FDA–
2011–P–0473]
Determination That the OXYCONTIN
(Oxycodone Hydrochloride) Drug
Products Covered by New Drug
Application 20–553 Were Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that OXYCONTIN (oxycodone
hydrochloride) extended-release tablets
(10 milligrams (mg), 15 mg, 20 mg, 30
mg, 40 mg, 60 mg, 80 mg, and 160 mg)
approved under new drug application
(NDA) 20–553 were withdrawn from
sale for reasons of safety or
effectiveness. The Agency will not
accept or approve abbreviated new drug
applications (ANDAs) for products that
reference NDA 20–553.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
I. Background
In 1984, Congress enacted the Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
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(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 U.S.C.
355(j)(7)(C); 21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made before
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
OXYCONTIN (oxycodone
hydrochloride) extended-release tablets,
10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60
mg, 80 mg, and 160 mg (original
OxyContin), are the subject of NDA 20–
553, held by Purdue Pharma LP
(Purdue) and initially approved on
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
December 12, 1995. A reformulated
version of these products, OXYCONTIN
(oxycodone hydrochloride) extendedrelease tablets, 10 mg, 15 mg, 20 mg, 30
mg, 40 mg, 60 mg, and 80 mg
(reformulated OxyContin), are the
subject of NDA 22–272, also held by
Purdue and initially approved on April
5, 2010. Reformulated OxyContin was
developed with physicochemical
properties that are intended to make the
tablet more difficult to manipulate for
purposes of abuse or misuse. Both
original and reformulated OxyContin
are opioid agonist products indicated
for the management of moderate to
severe pain when a continuous, aroundthe-clock opioid analgesic is needed for
an extended period of time.
In correspondence dated August 10,
2010, Purdue notified FDA that it had
ceased shipment of original OxyContin,
and FDA subsequently moved original
OxyContin to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. On April 16, 2013, FDA approved
a supplemental application for
reformulated OxyContin, approving
changes to the product labeling that
describe certain abuse-deterrent
properties of the reformulated product.
Several parties have submitted citizen
petitions under 21 CFR 10.30,
requesting that the Agency determine
whether original OXYCONTIN
(oxycodone hydrochloride) extendedrelease tablets were voluntarily
withdrawn from sale for reasons other
than safety or effectiveness.1
Based on the information available at
this time, FDA has determined under
§ 314.161 that original OxyContin was
1 Varam, Inc., Docket No. 2011–P–0473 (June 9,
2011) (10, 15, 20, 30, 40, 50, 80, and 160 mg);
Sheppard, Mullin, Richter & Hampton LLP, Docket
No. 2010–P–0540 (Oct. 8, 2010) (10, 15, 20, 30, 40,
60, and 80 mg); Lachman Consultant Services, Inc.,
Docket No. FDA–2010–P–0526) (Sept. 30, 2010) (10,
15, 20, 30, 40, 60, 80, and 160 mg). Lachman also
submitted a petition in 2001 concerning just
Purdue’s 2001 withdrawal of the 160 mg strength.
Docket No. FDA–2001–P–0473 (formerly Docket
No. 2001P–0426) (Sept. 18, 2001).
E:\FR\FM\18APN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23271-23273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09093]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0150]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Hypertension Indication: Drug
Labeling for Cardiovascular Outcome Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
associated with the guidance ``Hypertension Indication: Drug Labeling
for Cardiovascular Outcome Claims,'' which is intended to assist
applicants in developing labeling for outcome claims for drugs that are
indicated to treat hypertension.
DATES: Submit either electronic or written comments on the collection
of information by June 17, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug
[[Page 23272]]
Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Hypertension Indication: Drug Labeling for
Cardiovascular Outcome Claims--(OMB Control Number 0910-0670)--
Extension
This guidance is intended to assist applicants in developing
labeling for outcome claims for drugs that are indicated to treat
hypertension. With few exceptions, current labeling for
antihypertensive drugs includes only the information that these drugs
are indicated to reduce blood pressure; the labeling does not include
information on the clinical benefits related to cardiovascular outcomes
expected from such blood pressure reduction. However, blood pressure
control is well established as beneficial in preventing serious
cardiovascular events, and inadequate treatment of hypertension is
acknowledged as a significant public health problem. FDA believes that
the appropriate use of these drugs can be encouraged by making the
connection between lower blood pressure and improved cardiovascular
outcomes more explicit in labeling. The intent of the guidance is to
provide common labeling for antihypertensive drugs except where
differences are clearly supported by clinical data. The guidance
encourages applicants to submit labeling supplements containing the new
language.
The guidance contains two provisions that are subject to OMB review
and approval under the PRA, and one provision that would be exempt from
OMB review:
(1) Section IV.C of the guidance requests that the CLINICAL STUDIES
section of the Full Prescribing Information of the labeling should
include a summary of placebo or active-controlled trials showing
evidence of the specific drug's effectiveness in lowering blood
pressure. If trials demonstrating cardiovascular outcome benefits
exist, those trials also should be summarized in this section. Table 1
in Section V of the guidance contains the specific drugs for which FDA
has concluded that such trials exist. If there are no cardiovascular
outcome data to cite, one of the following two paragraphs should
appear:
``There are no trials of [DRUGNAME] or members of the [name of
pharmacologic class] pharmacologic class demonstrating reductions in
cardiovascular risk in patients with hypertension,'' or ``There are
no trials of [DRUGNAME] demonstrating reductions in cardiovascular
risk in patients with hypertension, but at least one
pharmacologically similar drug has demonstrated such benefits.''
In the latter case, the applicant's submission generally should
refer to table 1 in section V of the guidance. If the applicant
believes that table 1 is incomplete, it should submit the clinical
evidence for the additional information to Docket No. FDA-2008-D-0150.
The labeling submission should reference the submission to the docket.
FDA estimates that no more than one submission to the docket will be
made annually from one company, and that each submission will take
approximately 10 hours to prepare and submit. Concerning the
recommendations for the CLINICAL STUDIES section of the Full
Prescribing Information of the labeling, FDA regulations at Sec. Sec.
201.56 and 201.57 (21 CFR 201.56 and 201.57) require such labeling, and
the information collection associated with these regulations is
approved by OMB under OMB control number 0910-0572.
(2) Section VI.B of the guidance requests that the format of
cardiovascular outcome claim prior approval supplements submitted to
FDA under the guidance should include the following information:
1. A statement that the submission is a cardiovascular outcome
claim supplement, with reference to the guidance and related Docket No.
FDA-2008-D-0150.
2. Applicable FDA forms (e.g., 356h, 3397).
3. Detailed table of contents.
4. Revised labeling:
a. Include draft revised labeling conforming to the requirements in
Sec. Sec. 201.56 and 201.57;
b. Include marked-up copy of the latest approved labeling, showing
all additions and deletions, with annotations of where supporting data
(if applicable) are located in the submission.
FDA estimates that approximately 20 cardiovascular outcome claim
supplements will be submitted annually from approximately 8 different
companies, and that each supplement will take approximately 20 hours to
prepare and submit. The guidance also recommends that other labeling
changes (e.g., the addition of adverse event data) should be minimized
and provided in separate supplements, and that the revision of labeling
to conform to Sec. Sec. 201.56 and 201.57 may require substantial
revision to the ADVERSE REACTIONS or other labeling sections.
(3) Section VI.C of the guidance states that applicants are
encouraged to include the following statement in promotional materials
for the drug.
''[DRUGNAME] reduces blood pressure, which reduces the risk of
fatal and nonfatal cardiovascular events, primarily strokes and
myocardial infarctions. Control of high blood pressure should be
part of comprehensive cardiovascular risk management, including, as
appropriate, lipid control, diabetes management, antithrombotic
therapy, smoking cessation, exercise, and limited sodium intake.
Many patients will require more than one drug to achieve blood
pressure goals.''
The inclusion of this statement in the promotional materials for
the drug would be exempt from OMB review based on 5 CFR 1320.3(c)(2),
which
[[Page 23273]]
states that ``The public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public is not included * * *'' within the definition
of ``collection of information.''
FDA requests public comments on the information collection
provisions described in this document and set forth in the following
table:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Submission to Docket Number FDA- 1 1 1 10 10
2008-D-0150....................
Cardiovascular Outcome Claim 8 2.5 20 20 400
Supplement Submission..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 410
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09093 Filed 4-17-13; 8:45 am]
BILLING CODE 4160-01-P
