Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 14401 

STATE DOMESTIC VIOLENCE COALITIONS AS DESIGNATED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, 

ADMINISTRATION FOR CHILDREN AND FAMILIES, ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES AS OF DECEMBER 2011—Continued 

Coalition name City State 

Virginia Sexual & Domestic Violence Action Alliance ......................................................... Richmond ..................................................... VA 

Virgin Islands Domestic Violence and Sexual Assault Council .......................................... Kingshill ........................................................ VI 

Washington State Coalition Against Domestic Violence ..................................................... Seattle .......................................................... WA 

West Virginia Coalition Against Domestic Violence ............................................................ Elkview ......................................................... WV 

Wisconsin Coalition Against Domestic Violence ................................................................. Madison ........................................................ WI 

Wyoming Coalition Against Domestic Violence & Sexual Assault ...................................... Laramie ........................................................ WY 

[FR Doc. 2012–5825 Filed 3–8–12; 8:45 am] 

BILLING CODE 4184–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–D–0339] 

Draft Guidance on Drug Safety 

Information—FDA’s Communication to 

the Public; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance titled 

‘‘Drug Safety Information—FDA’s 

Communication to the Public.’’ This 

draft guidance updates and revises the 

March 2007 guidance entitled ‘‘Drug 

Safety Information—FDA’s 

Communication to the Public.’’ This 

draft guidance describes FDA’s current 

approach to communicating important 

drug safety information, including 

emerging drug safety information, to the 

public and the factors that influence 

when the information is communicated. 

The draft guidance was developed in 

connection with the Center for Drug 

Evaluation and Research’s (CDER’s) 

Safety First Initiative. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 8, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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; or Office 

of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft 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: 

Edward Staffa, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Rm. 1152, Silver 

Spring, MD 20993, 301–796–5301. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Drug Safety 

Information—FDA’s Communication to 

the Public.’’ This draft guidance updates 

and revises a March 2007 guidance of 

the same name. It describes FDA’s 

current approach to communicating 

important drug safety information, 

including emerging drug safety 

information, to the public and the 

factors that influence when the 

information is communicated. 

For many years, FDA has provided 

information on drug risks and benefits 

to health care professionals and patients 

when that information has generated a 

specific concern, usually waiting until 

that information has been fully 

evaluated and has prompted an action, 

such as a revision to the drug’s 

prescribing information. In recent years, 

FDA has tended to make information on 

potential drug risks available to the 

public earlier, often while the Agency is 

still evaluating the data and determining 

whether any action is warranted. FDA 

believes that timely communication of 

important drug safety information will 

give health care professionals, patients, 

consumers, and other interested persons 

access to the most current information 

concerning the potential risks and 

benefits of a marketed drug, helping 

them to make more informed individual 

treatment choices. 

In the Federal Register of March 7, 

2007 (72 FR 10224), FDA announced the 

availability of a guidance titled ‘‘Drug 

Safety Information—FDA’s 

Communication to the Public.’’ FDA has 

revised the 2007 guidance to provide 

updated information about its approach 

to communicating important drug safety 

information, including FDA’s 

development of a single, standardized 

format for electronic drug safety 

communications about marketed drugs. 

In addition, the draft guidance describes 

FDA’s posting of other safety 

assessments on its Web site in 

accordance with the requirements of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) and 

to further our transparency objectives. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

replace the 2007 guidance and represent 

the Agency’s current thinking on this 

topic. 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. 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 draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 


srobinson on DSK4SPTVN1PROD with NOTICES
14402 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

310.305, 314.80, 314.98, 600.80, and in 

21 U.S.C. 379aa have been approved 

under OMB Control Numbers 0910– 

0230, 0910–0291, 0910–0308, and 0910– 

0636. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda

.gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http:// 

www.regulations.gov. 

Dated: March 6, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5775 Filed 3–8–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0085] 

Draft Guidance on Classifying 

Significant Postmarket Drug Safety 

Issues; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Classifying Significant Postmarket 

Drug Safety Issues.’’ This draft guidance 

describes FDA’s current approach to 

classifying a significant postmarket drug 

safety issue as a ‘‘priority’’ tracked 

safety issue (TSI) or a ‘‘standard’’ TSI, 

with the capability of elevating some 

priority TSIs to an ‘‘emergency’’ status. 

The draft guidance was developed in 

connection with the Center for Drug 

Evaluation and Research’s (CDER’s) 

Safety First Initiative. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 8, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft guidance document. 

Submit electronic comments on the 

draft 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: 

Michie Hunt, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6153, Silver Spring, 

MD 20993–0002, 301–796–3504. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Classifying 

Significant Postmarket Drug Safety 

Issues.’’ This draft guidance describes 

CDER’s current approach to determining 

whether a significant postmarket drug 

safety issue should be classified as a 

‘‘priority,’’ as a ‘‘standard,’’ or as an 

‘‘emergency’’ tracked safety issue (TSI). 

CDER receives a constant flow of 

information about potential drug safety 

issues, and the seriousness of reported 

problems varies widely. Those that 

CDER determines to be significant safety 

issues are tracked in the Center’s 

Document Archiving, Reporting, and 

Regulatory Tracking System (DARRTS), 

a centralized data base that enables staff 

working across the Center to share 

information. To be considered 

significant, the safety issue of concern 

must meet certain criteria. In general, 

CDER considers postmarket safety 

issues to be significant if they have the 

potential to lead to any of the following 

actions: 

• Withdrawal of an approved drug 

from the market. 

• Withdrawal of an approved 

indication. 

• Limitations of a use in a specific 

population or subpopulation. 

• Additions or modifications to the 

Contraindications or Warnings and 

Precautions sections of the labeling, to 

the Medication Guide or other required 

Patient Package Insert, including safety 

labeling changes required under the 

Food and Drug Administration 

Amendments Act (FDAAA). 

• Establishment of or changes to the 

proprietary name/container label/ 

labeling/packaging to reduce the 

likelihood of medication errors. 

• Establishment or modification of a 

risk evaluation and mitigation strategy 

(REMS). 

• A requirement that a sponsor 

conduct a safety-related postmarket 

clinical trial or observational 

epidemiological study. 

• The conduct of a safety-related 

observational epidemiological study by 

FDA. 

Since the DARRTS safety tracking 

function was introduced in 2007, about 

1,000 TSIs have been entered into the 

system. Although all of these issues are 

considered significant, not all TSIs are 

equally urgent. Furthermore, CDER does 

not have adequate resources to manage 

all TSIs equally rapidly. In the past, 

prioritization of the TSIs has been 

handled informally and on a case-bycase basis, without an agreed upon 

framework for establishing priority. 

The Center is now seeking to establish 

a formal framework for assessing the 

relative urgency of TSIs, so that CDER 

can direct resources more effectively 

toward the issues that pose the greatest 

potential risk for patients. This 

framework will classify TSIs as 

‘‘priority’’ or ‘‘standard’’ for CDER 

review. In addition, the Center will 

recognize a special ‘‘emergency’’ 

category for certain priority TSIs. The 

use of a formal framework is intended 

to ensure that staff working in different 

offices across CDER reaches similar 

conclusions about the relative urgency 

of TSIs, and help them direct attention 

to those that need to be addressed most 

expeditiously. It will also inform CDER 

decisions about public drug safety 

communications, so that health care 

practitioners and patients receive timely 

information about safety risks with the 

greatest public health significance. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on this topic. 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. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 


srobinson on DSK4SPTVN1PROD with NOTICES