Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10753 

Silver Spring, MD 20993–0002, 301– 

796–9148. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2012–3548, appearing on page 8880, in 

the Federal Register of Wednesday, 

February 15, 2012, the following 

correction is made: 

On page 8880, in the second column, 

in the Docket No. heading, ‘‘[Docket No. 

FDA–2012–N–1029]’’ is corrected to 

read ‘‘[Docket No. FDA–2012–N–0129]’’. 

Dated: February 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4168 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0674] 

Draft Guidance for Industry: Food and 

Drug Administration Records Access 

Authority Under the Federal Food, 

Drug, and Cosmetic Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘FDA Records Access 

Authority Under Sections 414 and 704 

of the Federal Food, Drug, & Cosmetic 

Act.’’ This draft guidance provides 

updated information pertaining to 

FDA’s authority to access and copy 

records relating to food. It is a revision 

of FDA’s November 2005 guidance 

entitled ‘‘Guidance for Industry and 

FDA Staff: Guidance for Records Access 

Authority Provided in Title III, Subtitle 

A, of the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002; Final Guidance.’’ 

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on the draft guidance by May 23, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Outreach and Information Center (HFS– 

009), Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 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access to the draft guidance document.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draft guidance to http:// 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 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: 

William A. Correll, Jr., Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1611. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘FDA Records Access Authority Under 

Sections 414 and 704 of the Federal 

Food, Drug, & Cosmetic Act.’’ The draft 

guidance is intended for persons who 

manufacture, process, pack, hold, or 

import human or animal foods intended 

for distribution to consumers, 

institutions, or food processors. This 

draft guidance provides updated 

information pertaining to FDA’s 

authority to access and copy records 

relating to food under sections 414(a) 

and 704(a)(1)(B) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 350c(a) and 21 U.S.C. 

374(a)(1)(B), respectively), as amended 

by section 101 of the FDA Food Safety 

and Modernization Act (FSMA) (Pub. L. 

111–353) of January 4, 2011. 

Section 414 was originally added to 

the FD&C Act by the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (Pub. L. 107– 

188). FSMA, signed into law on January 

4, 2011, expanded FDA’s access to 

records under section 414. Prior to the 

passage of FSMA, section 414(a) of the 

FD&C Act provided the Secretary (by 

delegation FDA) with authority to 

access records relating to food that was 

reasonably believed to be adulterated 

and to present a threat of serious 

adverse health consequences or death to 

humans or animals. Now under section 

414(a)(1), as amended by FSMA, FDA’s 

records access extends beyond records 

relating to the specific suspect article of 

food to records relating to any other 

article of food that FDA reasonably 

believes is likely to be affected in a 

similar manner. In addition, under 

section 414(a)(2), FDA can access 

records if it believes that there is a 

reasonable probability that the use of or 

exposure to an article of food, and any 

other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner, will cause 

serious adverse health consequences or 

death to humans or animals. 

Furthermore, FSMA revised section 

704(a)(1)(B), which pertains to factory 

inspections, to refer to the amended 

version of section 414(a). 

This updated draft guidance is 

intended to provide individuals in the 

human and animal food industries with 

an overview of FDA’s authority to 

access and copy records. It provides 

practical information by answering 

common questions that cover a range of 

topics, including when FDA has the 

authority to access and copy records, 

the circumstances under which FDA is 

likely to request records, the types of 

records FDA may request and copy, and 

the consequences of refusing to provide 

records access. The Agency has adopted 

good guidance practices (GGPs) that set 

forth the Agency’s policies and 

procedures for the development, 

issuance, and use of guidance 

documents (21 CFR 10.115). This draft 

guidance is being issued as level 1 

guidance consistent with GGPs. 

The draft guidance, when finalized, 

will represent the Agency’s current 

thinking on its authority to access and 

copy records. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternate approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

information collection provisions 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). We 

conclude that these information 

collection provisions are exempt from 

OMB review under 44 U.S.C. 

3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) 

as collections of information obtained 

during the conduct of a civil action to 

which the United States or any official 

or Agency thereof is a party, or during 

the conduct of an administrative action, 

investigation, or audit involving an 

Agency against specific individuals or 

entities. The regulations in 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records. 

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10754 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

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. 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 guidance at either 

http://www.fda.gov/FoodGuidances or 

http://www.regulations.gov. Always 

access an FDA guidance document by 

using the Web sites listed previously to 

find the most current version of the 

guidance. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4166 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0327] 

International Conference on 

Harmonisation; Final Recommendation 

for the Revision of the Permitted Daily 

Exposure for the Solvent Cumene 

According to the Maintenance 

Procedures for the Guidance Q3C 

Impurities: Residual Solvents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final recommendation 

for the revision of the permitted daily 

exposure (PDE) for the solvent cumene 

according to the maintenance 

procedures for the guidance for industry 

entitled ‘‘Q3C Impurities: Residual 

Solvents.’’ The recommendation was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the recommendation to 

the Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The draft 

recommendation may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft 

recommendation. 

Submit electronic comments on the 

recommendation 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: 

Regarding the Q3C Guidance 

David Jacobson-Kram, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6488, 

Silver Spring, MD 20993, 301–796– 

0175. 

Regarding the ICH 

Michelle Limoli, Office of 

International Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3506, Silver Spring, 

MD 20993–0002, 301–796–4600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory Agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In 1999, ICH instituted a Q3C 

maintenance agreement and formed a 

maintenance Expert Working Group 

(Q3C EWG). The agreement provided for 

the reconsideration of solvent PDEs and 

allowed for minor changes to the tables 

and list that include the existing PDEs. 

The agreement also provided that new 

solvents and PDEs could be added to the 

tables and list based on adequate 

toxicity data. In the Federal Register of 

February 12, 2002 (67 FR 6542), FDA 

briefly described the process for 

proposing future revisions to the PDEs. 

In the same notice, the Agency 

announced its decision to delink the 

tables and list from the Q3C guidance 

and create a stand alone document 

entitled ‘‘Q3C—Tables and List’’ to 

facilitate making changes recommended 

by ICH. 

II. Revised PDE for Cumene 

In the Federal Register of July 20, 

2010 (75 FR 42098), FDA published a 

notice announcing the availability of a 

draft recommendation for the revision of 

the PDE for cumene according to the 

ICH maintenance procedures. The 

notice gave interested persons an 

opportunity to submit comments by 

September 20, 2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the recommendation was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory Agencies in 

February 2011. 

The final recommendation addresses 

the safety classification of cumene. 

When the Q3C guidance was published 

in 1997 (62 FR 67377, December 24, 

1997), cumene was listed as a class 3 

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