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Draft Guidance on Classifying 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availability of a draft guidance entitled 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 This draft guidance 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The draft guidance was developed in 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on the draft guidance by May 8, 2012.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single copies of the draft guidance to the 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access to the draft guidance document.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
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 14403 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: March 6, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5777 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–0167] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Norovirus Serological Reagents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Norovirus 

Serological Reagents.’’ This guidance 

document describes a means by which 

norovirus serological reagents may 

comply with the requirement of special 

controls for class II devices. This 

guidance document is to be 

implemented immediately as the special 

control for norovirus serological 

reagents. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Norovirus 

Serological Reagents’’ to the Division of 

Small Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

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: 

Steven Gitterman, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 66, Rm. 5518, Silver Spring, 

MD 20993–0002, 301–796–6694. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying norovirus serological 

reagents into class II (special controls) 

under section 513(f)(2) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360c(f)(2)). This 

guidance document will serve as the 

special control for norovirus serological 

reagents. Section 513(f)(2) of the FD&C 

Act provides that any person who 

submits a premarket notification under 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the FD&C Act (21 

U.S.C. 360c(f)(1)), request FDA to 

classify the device under the criteria set 

forth in section 513(a)(1) of the FD&C 

Act (21 U.S.C. 360c(a)(1)). FDA will, 

within 60 days of receiving such a 

request, classify the device by written 

order. This classification shall be the 

initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

II. Significance of Special Controls 

Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance is being implemented 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). 

Because of the timeframes established 

by section 513(f)(2) of the FD&C Act, 

FDA has determined that it is not 

feasible to allow for public participation 

before issuing this guidance as a final 

guidance document. Therefore, FDA is 

issuing this guidance document as a 

level 1 guidance document that is for 

immediate implementation. Although 

this guidance document is immediately 

in effect, it remains subject to comment 

in accordance with the Agency’s good 

guidance practices. 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of norovirus serological 

reagents classified under § 866.3395 (21 

CFR 866.3395). In order to be classified 

as a class II device under § 866.3395, a 

norovirus serological reagents must 

comply with the requirements of special 

controls; manufacturers must address 

the issues requiring special controls as 

identified in the guidance document, 

either by following the 

recommendations in the guidance 

document or by some other means that 

provides equivalent assurances of safety 

and effectiveness. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Norovirus 

Serological Reagents,’’ you may either 

send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1767 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 

21 CFR part 807, subpart E have been 

approved under OMB control number 

0910–0120 and the collections of 

information in 21 CFR part 801 and 21 

CFR 809.10 have been approved under 

OMB control number 0910–0485. 

V. 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