Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 14025 

availability of a guidance for industry 

entitled ‘‘Hypertension Indication: Drug 

Labeling for Cardiovascular Outcome 

Claims.’’ 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. The Agency 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. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Devi 

Kozeli, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 4183, Silver Spring, 

MD 20993–0002, 301–796–1128. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Hypertension Indication: Drug Labeling 

for Cardiovascular Outcome Claims.’’ 

The intent of the guidance is to provide 

common labeling for antihypertensive 

drugs except where differences are 

clearly supported by clinical data. With 

publication of this guidance, applicants 

are encouraged to submit labeling 

supplements containing the new 

language. 

A draft guidance of the same title was 

announced in the Federal Register on 

March 13, 2008 (73 FR 13546), and 

Docket No. FDA–2008–D–0150 was 

open for comments until May 12, 2008. 

Comments received from industry, 

professional societies, and consumer 

groups on the draft guidance were taken 

into consideration by FDA in finalizing 

this guidance. Throughout the guidance, 

the language has been condensed and 

simplified to be more concise and clear. 

A section has been added to clarify 

procedures for obtaining approval of 

new labeling and its applicability to 

advertising. The guidance describes 

how applicants can provide clinical 

evidence for any drugs they perceive to 

be missing from Table 1, Approved 

Drugs for Chronic Treatment of 

Hypertension, by submitting the 

information to the docket number listed 

in brackets in the heading of this 

document. The division will review the 

information and revise the guidance to 

include any new labeling changes 

supported by clinical data submitted to 

the docket. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on labeling for 

cardiovascular outcome claims for drugs 

to treat hypertension. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910–0670. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5945 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0568] 

Guidance for Industry on Planning for 

the Effects of High Absenteeism To 

Ensure Availability of Medically 

Necessary Drug Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products.’’ 

The guidance encourages manufacturers 

of medically necessary drug products 

(MNPs) and components to develop 

production plans in the event of an 

emergency that results in high 

absenteeism at one or more production 

facilities. The purpose of the guidance 

is to provide to industry considerations 

for developing plans for these types of 

emergencies, as well as to discuss the 

Center for Drug Evaluation and 

Research’s (CDER’s) intended approach 

to assist in avoiding drug product 

shortages that may have a negative 

impact on the national public health 

during such emergencies. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 


srobinson on DSKHWCL6B1PROD with NOTICES
14026 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Thomas J. Christl, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3358, 

Silver Spring, MD 20993–0002, 301– 

796–2057. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products.’’ 

The guidance encourages manufacturers 

of MNPs and components to develop 

production plans in the event of an 

emergency that results in high 

absenteeism at one or more production 

facilities. In particular, the guidance 

provides recommendations regarding 

considerations for the development and 

implementation of a production plan, 

including specific elements to include 

in such a plan. The guidance is 

intended for manufacturers of finished 

drug products as well as manufacturers 

of the raw materials necessary for 

manufacturing of an MNP. 

The purpose of this guidance is to 

provide to industry considerations for 

developing plans for these types of 

emergencies, as well as to discuss 

CDER’s intended approach to assist in 

avoiding shortages that may have a 

negative impact on the national public 

health during such emergencies. This 

guidance applies to manufacturers of 

drug and therapeutic biologic products 

regulated by CDER, and any 

components of those products. These 

considerations include, but are not 

limited to: 

• General preparedness through 

employee education and immunization, 

• Prioritization of manufactured 

products based on medical necessity, 

• Developing training, manufacturing 

and laboratory contingencies for high 

absenteeism, and 

• How to plan for returning to normal 

operations. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on planning for the 

effects of high absenteeism to ensure 

availability of MNPs. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

this guidance were approved under 

OMB control number 0910–0675. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5949 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Antiviral Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Antiviral Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 27, 2011, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings’’. 

Please note that visitors to the White 

Oak Campus must enter through 

Building 1. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8540, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On April 27, 2011, the 

committee will discuss a new drug 

application (NDA) 202–258, boceprevir 

(a hepatitis C virus protease inhibitor), 

manufactured by Merck & Co., Inc., with 

a proposed indication for the treatment 

of chronic hepatitis C genotype 1 

infection, in combination with 

peginterferon alfa and ribavirin (two 

medicines approved to treat chronic 

hepatitis C infection) in adult patients 

with compensated liver disease who are 

previously untreated or who have failed 

previous therapy. Compensated liver 

disease is a stage in which the liver is 

damaged but maintains ability to 

function. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 


srobinson on DSKHWCL6B1PROD with NOTICES