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
14404 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: March 5, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–5674 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–2002–D–0094; (formerly 

Docket No. 02D–0049)] 

Guidance for the Public, Food and 

Drug Administration (FDA) Advisory 

Committee Members, and FDA Staff: 

Public Availability of Advisory 

Committee Members’ Financial Interest 

Information and Waivers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for the public, 

FDA advisory committee members, and 

FDA staff, entitled ‘‘Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers.’’ We are issuing the 

guidance to help the public, FDA 

advisory committee members, and FDA 

staff to understand the public 

availability of information regarding 

certain financial interests and waivers 

granted by FDA to permit individuals to 

participate in an advisory committee 

meeting. The guidance provides 

additional transparency to FDA’s 

advisory committee process beyond 

current guidance. This guidance 

finalizes the draft guidance of the same 

title dated March 2010 and replaces the 

guidance of the same title dated August 

2008. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to 

Advisory Committee Oversight and 

Management Staff, Office of Special 

Medical Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5103, Silver Spring, 

MD 20993. Send one self-addressed 

adhesive label to assist that office in 

processing your request. 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 on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5104, Silver Spring, 

MD 20993, email: 

Michael.Ortwerth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. The Guidance 

FDA is announcing the availability of 

a guidance entitled, ‘‘Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers.’’ FDA issues guidance 

documents for FDA staff, applicants and 

sponsors, and the public that describe 

the Agency’s current views on a subject. 

In January 2002, FDA issued draft 

guidance on ‘‘Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ and 

requested comments on the draft 

guidance (formerly Docket No. 02D– 

0049, now Docket No. FDA–2002–D– 

0094, 67 FR 6545, February 12, 2002). 

The draft guidance was limited in 

application to special government 

employees (SGEs) participating in 

advisory committee meetings at which 

particular matters relating to particular 

products were discussed. In October 

2007, after an internal assessment of 

FDA’s advisory committee process, FDA 

published a revised draft guidance for 

public comment (72 FR 61657, October 

31, 2007). The Agency reviewed the 

submitted comments on the January 

2002 draft guidance, the October 2007 

draft guidance, and the results of the 

internal assessment of FDA’s advisory 

committee process and issued guidance 

that expanded public availability of 

relevant information to include regular 

Government employees and SGEs, 

brought additional transparency to 

FDA’s waiver process, and increased the 

consistency and clarity of the process 

(73 FR 45459, August 5, 2008) 

(www.fda.gov/downloads/ 

RegulatoryInformation/Guidances/ 

ucm125647.pdf). 

In the Federal Register of April 22, 

2010 (75 FR 21000), FDA issued for 

public comment ‘‘Draft Guidance for the 

Public, FDA Advisory Committee 

Members, and FDA Staff: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers,’’ dated March 2010. The 

Agency explained that it tentatively 

concluded it is appropriate for 

additional information to be disclosed 

for individuals receiving a waiver of 

conflict of interest prior to participating 

in an FDA advisory committee meeting. 

Specifically, FDA proposed disclosure 

of the name of the company or 

institution associated with the financial 

interest. The Agency based its draft 

guidance on the expectation that: (1) 

This information would help the public 

understand the nature of the potential 

conflict and FDA’s decision-making and 

that (2) individuals invited as advisory 

committee members would agree to the 

inclusion of this level of detail as a 

routine part of required disclosures. 

FDA specifically requested comments 

on whether disclosing the name of the 

company or institution associated with 

the financial interest would: (1) Increase 

the transparency of FDA’s decisions 

regarding advisory committee member 

participation and (2) not significantly 

deter current and potential advisory 

committee members from service on 

those committees. The draft guidance 

also included a template for disclosing 

to the public the financial interests for 

which waivers are granted, a template 

for public disclosure of waivers that 

FDA grants, and FDA’s process for 

making these documents available on its 

Web site. 

We received several comments on the 

draft guidance. No commenter indicated 

that the proposed policies would deter 

participation and most noted that it 

would increase transparency. 

FDA is issuing the draft guidance 

with minor revisions to improve clarity. 

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 the public 

availability of financial interest 

information and waivers relating to the 

disclosure of conflicts of interest for 

advisory committee members 

participating in FDA advisory 

committee meetings. 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 


srobinson on DSK4SPTVN1PROD with NOTICES