tkelley on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 217 / Thursday, November 8, 2012 / Notices 67013 


DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the Battelle Laboratories King Avenue 

Facility in Columbus, OH, To Be 

Included in the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

Battelle Laboratories King Avenue 

facility in Columbus, OH, to be included 

in the Special Exposure Cohort under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. The initial proposed definition for 

the class being evaluated, subject to 

revision as warranted by the evaluation, 

is as follows: 

Facility: Battelle Laboratories King 

Avenue Location: Columbus, Ohio. 

Job Titles and/or Job Duties: All 

Atomic Weapons Employees who 

worked at the King Avenue facility in 

Columbus, Ohio. 

Period of Employment: April 16, 1943 

through June 30, 1956. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2012–27346 Filed 11–7–12; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0848] 

Draft Compliance Policy Guide Sec. 

550.050 Canned Ackee, Frozen Ackee, 

and Other Ackee Products— 

Hypoglycin A Toxin; Availability 

AGENCY: Food and Drug Administration, 


HHS. 


ACTION: Notice. 


SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

Compliance Policy Guide entitled 

‘‘Compliance Policy Guide Sec. 550.050 

Canned Ackee, Frozen Ackee, and Other 

Ackee Products—Hypoglycin A Toxin 

(the draft CPG).’’ The draft CPG, when 

finalized, will provide guidance for FDA 

staff on our enforcement criteria for 

canned ackee, frozen ackee, and other 

ackee products that contain hypoglycin 

A. 

DATES: Although you can comment on 

any CPG at any time (see 21 CFR 

10.115(g)(5)), to ensure that FDA 

considers your comment on the draft 

CPG before it begins work on the final 

version of the CPG, submit electronic or 

written comments on the draft CPG by 

January 7, 2013. 

ADDRESSES: Submit written requests for 

single copies of the draft CPG to the 

Division of Compliance Policy (HFC– 

230), Office of Enforcement, Food and 

Drug Administration, 12420 Parklawn 

Dr., Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 240–632–6861. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft CPG. 

Submit electronic comments on the 

draft CPG 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: 

Yinqing Ma, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1700. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

the draft CPG entitled ‘‘Compliance 

Policy Guide Sec. 550.050 Canned 

Ackee, Frozen Ackee, and Other Ackee 

Products—Hypoglycin A Toxin.’’ The 

draft CPG is intended to provide 

guidance for FDA staff regarding 

hypoglycin A in canned ackee, frozen 

ackee, and other ackee products. We 

have concluded that canned ackee, 

frozen ackee, and other ackee products 

containing concentrations of hypoglycin 

A above 100 parts per million (ppm) 

have not been processed properly, and 

that the finished product may be 

injurious to health. As stated in the draft 

CPG, canned ackee, frozen ackee, and 

other ackee products may be considered 

adulterated within the meaning of 

section 402(a)(4) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

342(a)(4)) when hypoglycin A is present 

in the food at levels greater than 100 

ppm. The draft CPG also contains 

information that may be useful to the 

regulated industry and to the public. 

The draft CPG is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft CPG, when finalized, will 

represent our current thinking on 

hypoglycin A in ackee products. 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. Comments 

Interested persons may submit either 

written comments regarding the draft 

CPG to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments to http:// 

www.regulations.gov. 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, and 

will be posted to the docket at http:// 

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft CPG either from 

FDA’s Office of Regulatory Affairs 

history page at http://www.fda.gov/ora/ 

compliance_ref/cpg/default.htm or from 

http://www.regulations.gov. Always 

access an FDA guidance document by 

using FDA’s Web site listed in the 

previous sentence to find the most 

current version of the guidance. 

Dated: November 1, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–27225 Filed 11–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 


HHS. 


ACTION: Notice. 


This notice announces a forthcoming 

meeting of a public advisory committee