81 FR 76359 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 212 (November 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76359-76360 | |
| FR Document | 2016-26399 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Notices] [Pages 76359-76360] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26399] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0117] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by December 2, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0670. Also include the FDA docket number found in brackets in the heading of this document. 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:A statement that the submission is a cardiovascular outcome claim supplement, with reference to the guidance and related Docket No. FDA-2008-D-0150. Applicable FDA forms (e.g., 356h, 3397). Detailed table of contents. Revised labeling to: [cir] Include draft revised labeling conforming to the requirements in Sec. Sec. 201.56 and 201.57 and [cir] 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 1 cardiovascular outcome claim supplement will be submitted annually from approximately 1 different companies, and that each supplement will take approximately 20 hours to [[Page 76360]] 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 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. In the Federal Register of February 22, 2016 (81 FR 8726), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Hours per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- Submission to Docket No. FDA- 1 1 1 10 10 2008-D-0150.................... Cardiovascular Outcome Claim 1 1 1 20 20 Supplement Submission.......... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 30 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26399 Filed 11-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76359
maximize C2C’s impact. The next three DATES: Fax written comments on the concluded that such trials exist. If there
years will be dedicated to implementing collection of information by December are no cardiovascular outcome data to
the evaluation described in this 2, 2016. cite, one of the following two
submission. We are proposing four data ADDRESSES: To ensure that comments on paragraphs should appear:
collection activities: (1) A cross- the information collection are received, ‘‘There are no trials of [DRUGNAME]
sectional survey of organizations that OMB recommends that written or members of the [name of
have ordered and used the materials comments be faxed to the Office of pharmacologic class] pharmacologic
with consumers; (2) A cross-sectional Information and Regulatory Affairs, class demonstrating reductions in
survey of consumers, drawn from the OMB, Attn: FDA Desk Officer, FAX: cardiovascular risk in patients with
Knowledge Networks panel, to measure 202–395–7285, or emailed to oira_ hypertension,’’ or ‘‘There are no trials of
the association between C2C and submission@omb.eop.gov. All [DRUGNAME] demonstrating
consumer knowledge and behavior; (3) comments should be identified with the reductions in cardiovascular risk in
semi-structured interviews with staff OMB control number 0910–0670. Also patients with hypertension, but at least
from a limited set of community include the FDA docket number found one pharmacologically similar drug has
organizations as part of a case study; in brackets in the heading of this demonstrated such benefits.’’
and (4) focus groups of consumers as document. In the latter case, the applicant’s
part of a case study. The case study will submission generally should refer to
Guidance for Industry on Hypertension table 1 in section V of the guidance. If
be conducted in a community where
Indication: Drug Labeling for the applicant believes that table 1 is
English is not the preferred language, Cardiovascular Outcome Claims; OMB
and where C2C materials in another incomplete, it should submit the
Control Number 0910–0670—Extension clinical evidence for the additional
language (e.g., Spanish, Arabic, Chinese,
Haitian Creole, Korean, Russian, and This guidance is intended to assist information to Docket No. FDA–2008–
Vietnamese) were used with consumers. applicants in developing labeling for D–0150. The labeling submission
Form Number: CMS–10632 (OMB outcome claims for drugs that are should reference the submission to the
control number: 0938-New); Frequency: indicated to treat hypertension. With docket. FDA estimates that no more
Occasionally; Affected Public: few exceptions, current labeling for than one submission to the docket will
Individuals or Households; Number of antihypertensive drugs includes only be made annually from one company,
Respondents: 3,460; Total Annual the information that these drugs are and that each submission will take
Responses: 3,460; Total Annual Hours: indicated to reduce blood pressure; the approximately 10 hours to prepare and
1,176. (For policy questions regarding labeling does not include information submit. Concerning the
this collection contact Ashley on the clinical benefits related to recommendations for the CLINICAL
Peddicord-Austin at 410–786–0757). cardiovascular outcomes expected from STUDIES section of the Full Prescribing
such blood pressure reduction. Information of the labeling, FDA
Dated: October 28, 2016. However, blood pressure control is well regulations at §§ 201.56 and 201.57 (21
William N. Parham, III, established as beneficial in preventing CFR 201.56 and 201.57) require such
Director, Paperwork Reduction Staff, Office serious cardiovascular events, and labeling, and the information collection
of Strategic Operations and Regulatory inadequate treatment of hypertension is associated with these regulations is
Affairs. acknowledged as a significant public approved by OMB under OMB control
[FR Doc. 2016–26493 Filed 11–1–16; 8:45 am] health problem. FDA believes that the number 0910–0572.
BILLING CODE 4120–01–P appropriate use of these drugs can be 2. Section VI.B of the guidance
encouraged by making the connection requests that the format of
between lower blood pressure and cardiovascular outcome claim prior
DEPARTMENT OF HEALTH AND improved cardiovascular outcomes approval supplements submitted to FDA
HUMAN SERVICES more explicit in labeling. The intent of under the guidance should include the
the guidance is to provide common following information:
Food and Drug Administration labeling for antihypertensive drugs • A statement that the submission is
except where differences are clearly a cardiovascular outcome claim
[Docket No. FDA–2010–N–0117] supported by clinical data. The supplement, with reference to the
guidance encourages applicants to guidance and related Docket No. FDA–
Agency Information Collection submit labeling supplements containing 2008–D–0150.
Activities; Submission for Office of the new language. • Applicable FDA forms (e.g., 356h,
Management and Budget Review; The guidance contains two provisions 3397).
Comment Request; Guidance for that are subject to OMB review and • Detailed table of contents.
Industry on Hypertension Indication: approval under the PRA and one • Revised labeling to:
Drug Labeling for Cardiovascular provision that would be exempt from Æ Include draft revised labeling
Outcome Claims OMB review: conforming to the requirements in
1. Section IV.C of the guidance §§ 201.56 and 201.57 and
AGENCY: Food and Drug Administration, requests that the CLINICAL STUDIES Æ include marked-up copy of the
HHS. section of the Full Prescribing latest approved labeling, showing all
ACTION: Notice. Information of the labeling should additions and deletions, with
include a summary of placebo or active- annotations of where supporting data (if
SUMMARY: The Food and Drug controlled trials showing evidence of
sradovich on DSK3GMQ082PROD with NOTICES
applicable) are located in the
Administration (FDA or we) is the specific drug’s effectiveness in submission.
announcing that a proposed collection lowering blood pressure. If trials FDA estimates that approximately 1
of information has been submitted to the demonstrating cardiovascular outcome cardiovascular outcome claim
Office of Management and Budget benefits exist, those trials also should be supplement will be submitted annually
(OMB) for review and clearance under summarized in this section. Table 1 in from approximately 1 different
the Paperwork Reduction Act of 1995 Section V of the guidance contains the companies, and that each supplement
(the PRA). specific drugs for which FDA has will take approximately 20 hours to
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![76360 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
prepare and submit. The guidance also and nonfatal cardiovascular events, based on 5 CFR 1320.3(c)(2), which
recommends that other labeling changes primarily strokes and myocardial states that the public disclosure of
(e.g., the addition of adverse event data) infarctions. Control of high blood information originally supplied by the
should be minimized and provided in pressure should be part of Federal government to the recipient for
separate supplements, and that the comprehensive cardiovascular risk the purpose of disclosure to the public
revision of labeling to conform to management, including, as appropriate, is not included within the definition of
§§ 201.56 and 201.57 may require lipid control, diabetes management, collection of information.
substantial revision to the ADVERSE antithrombotic therapy, smoking In the Federal Register of February
REACTIONS or other labeling sections. cessation, exercise, and limited sodium 22, 2016 (81 FR 8726), we published a
3. Section VI.C of the guidance states intake. Many patients will require more 60-day notice requesting public
that applicants are encouraged to than one drug to achieve blood pressure comment on the proposed extension of
include the following statement in goals.’’ this collection of information. No
promotional materials for the drug. The inclusion of this statement in the comments were received.
‘‘[DRUGNAME] reduces blood promotional materials for the drug We estimate the burden of this
pressure, which reduces the risk of fatal would be exempt from OMB review collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Hours
Number of responses Total
Activity annual per
respondents per hours
responses response
respondent
Submission to Docket No. FDA–2008–D–0150 .................. 1 1 1 10 10
Cardiovascular Outcome Claim Supplement Submission ... 1 1 1 20 20
Total .............................................................................. ........................ ........................ ........................ ........................ 30
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 27, 2016. submit either electronic or written Written/Paper Submissions
Leslie Kux, comments on the draft revised guidance Submit written/paper submissions as
Associate Commissioner for Policy. by January 3, 2017. follows:
[FR Doc. 2016–26399 Filed 11–1–16; 8:45 am]
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P
as follows: written/paper submissions): Division of
Dockets Management (HFA–305), Food
Electronic Submissions and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES Submit electronic comments in the
• For written/paper comments
following way:
Food and Drug Administration submitted to the Division of Dockets
• Federal eRulemaking Portal: http:// Management, FDA will post your
[Docket No. FDA–2004–D–0369] www.regulations.gov. Follow the comment, as well as any attachments,
instructions for submitting comments. except for information submitted,
Animal Drug User Fees and Fee Comments submitted electronically, marked and identified, as confidential,
Waivers and Reductions; Draft Revised including attachments, to http:// if submitted as detailed in
Guidance for Industry; Availability www.regulations.gov will be posted to ‘‘Instructions.’’
AGENCY: Food and Drug Administration, the docket unchanged. Because your Instructions: All submissions received
HHS. comment will be made public, you are must include the Docket No. FDA–
ACTION: Notice of availability. solely responsible for ensuring that your 2004–D–0369 for ‘‘Animal Drug User
comment does not include any Fees and Fee Waivers and Reductions.’’
SUMMARY: The Food and Drug confidential information that you or a Received comments will be placed in
Administration (FDA or Agency) is third party may not wish to be posted, the docket and, except for those
announcing the availability of a draft such as medical information, your or submitted as ‘‘Confidential
revised guidance for industry (GFI) #170 anyone else’s Social Security number, or Submissions,’’ publicly viewable at
entitled ‘‘Animal Drug User Fees and confidential business information, such http://www.regulations.gov or at the
Fee Waivers and Reductions.’’ This draft Division of Dockets Management
as a manufacturing process. Please note
revised guidance document describes between 9 a.m. and 4 p.m., Monday
that if you include your name, contact
the types of fees the Food and Drug through Friday.
information, or other information that
Administration (FDA or the Agency) is
identifies you in the body of your • Confidential Submissions—To
authorized to collect under the Animal submit a comment with confidential
Drug User Fee Act of 2003 (ADUFA), as comments, that information will be
information that you do not wish to be
amended, and how to request waivers posted on http://www.regulations.gov.
made publicly available, submit your
sradovich on DSK3GMQ082PROD with NOTICES
and reductions from these fees. • If you want to submit a comment comments only as a written/paper
DATES: Although you can comment on with confidential information that you submission. You should submit two
any guidance at any time (see 21 CFR do not wish to be made available to the copies total. One copy will include the
10.115(g)(5)), to ensure that the Agency public, submit the comment as a information you claim to be confidential
considers your comment on this draft written/paper submission and in the with a heading or cover note that states
revised guidance before it begins work manner detailed (see ‘‘Written/Paper ‘‘THIS DOCUMENT CONTAINS
on the final version of the guidance, Submissions’’ and ‘‘Instructions’’). CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2016-11-02 01:40:48
Document Modified: 2016-11-02 01:40:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 2, 2016. | |
| FR Citation | 81 FR 76359 |
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