Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 81543 

6Proposed § 170.36(g)(3)(iii) stated that we would 

inform a petitioner who did not submit a 

conversion amendment that the notice was 

inadequate within 90 days of publication of the 

final rule, rather than within 90 days of the effective 

date of the final rule. This was an error. 

submitted GRAS notice. However, by 90 

days after the effective date of the final 

rule,6 we would inform any affected 

petitioner who had not submitted a 

certification that the converted petition 

was inadequate as a notice. 

A few comments stated that the 1997 

proposed rule did not discuss the fate of 

a pending petition if the petitioner 

elected not to submit a conversion 

amendment. These comments did not 

understand the implications of the 

proposed provisions which, in essence, 

would consider that the affected 

petitioner had not provided a basis for 

a conclusion of GRAS status. 

Many comments objected to the 

proposed provisions regarding pending 

petitions. In general, these comments 

expressed the opinion that our proposal 

was fundamentally unfair to an affected 

petitioner because an affected petitioner 

had invested considerable time and 

resources in the petition process. Some 

comments suggested that we 

‘‘grandfather’’ a pending petition (i.e., 

complete the rulemaking that began 

under the petition process), as a matter 

of course, in those circumstances where 

we had completed our scientific review 

and had no outstanding scientific 

questions. Other comments suggested 

that such a ‘‘grandfather’’ provision be 

an option available to an affected 

petitioner rather than a matter of course. 

One comment recommended that the 

final rule provide a petitioner with a 

period of 180, rather than 90, days to 

submit the dated and signed document 

providing information in proposed 

§ 170.36(c)(1). This comment argued 

that many of these petitions had been 

pending for years, that the subjects of 

the petitions had been marketed during 

those years, and that there would 

therefore be no urgency in closing the 

applicable files. 

In light of the view of the comments 

that our proposed disposition of 

pending petitions was unfair, in this 

document we are seeking comments 

regarding pending petitions. 

Specifically, we seek comment on how 

to reduce the impact on affected 

petitioners while retaining the principle 

that we will not devote resources to 

pending petitions. We seek comment on 

whether an outcome of ‘‘withdrawal 

without prejudice’’ instead of 

‘‘insufficient basis’’ would be more 

appropriate when an affected petitioner 

simply chooses not to have the pending 

petition considered under the GRAS 

notification procedure. We are seeking 

comment on whether an affected 

petitioner could request that we 

incorporate by reference a withdrawn 

GRAS affirmation petition into a GRAS 

notice, and if so, if any requirements of 

the GRAS notification procedure should 

be waived. 

We also note that, as discussed in the 

experience document (Ref. 1), during 

the interim period we processed a 

pending petition as a food additive 

petition and issued a food additive 

regulation for the petitioned substance 

(21 CFR 172.780; 70 FR 8032, February 

17, 2005). We note that CVM has no 

pending GRAS petitions and thus, this 

discussion is not applicable to GRAS 

affirmation petitions for food for 

animals. 

III. Costs and Benefits 

FDA requests comments on how the 

issues discussed in this document could 

affect the costs and benefits estimated in 

the 1997 proposed rule, e.g., whether 

these issues would result in costs or 

benefits that would be either greater 

than, or less than, those estimated in the 

1997 proposed rule (62 FR 18938 at 

18958). 

IV. Paperwork Reduction Act of 1995 

The 1997 proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Interested persons 

are requested to send comments 

regarding information collection to FDA 

(see DATES and ADDRESSES). 

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. It is no longer necessary to 

send two copies of mailed 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. 

VI. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES). 

You may see them between 9 a.m. and 

4 p.m., Monday through Friday. (FDA 

has verified the Web site addresses, but 

FDA is not responsible for any 

subsequent changes to Web sites after 

this document publishes in the Federal 

Register.) 

1. Experience With GRAS Notices 

Under the 1997 Proposed Rule, 

Memorandum Dated November 4, 2010, 

from Linda S. Kahl of FDA to Docket 

No. FDA–1997–N–0020. 

2. United States Government 

Accountability Office, Report to 

Congressional Requestors on Food 

Safety: FDA Should Strengthen Its 

Oversight of Food Ingredients 

Determined To Be Generally Recognized 

as Safe (GRAS), Report No. GAO–10– 

246, February 2010, Accessible at http:// 

www.gao.gov/new.items/d10246.pdf, 

Accessed and printed on May 3, 2010. 

3. Memorandum for the Heads of 

Executive Departments and Agencies, 

Dated June 1, 1998, Signed by President 

William J. Clinton, Accessible at http:// 

www.plainlanguage.gov/whatisPL/gov

mandates/memo.cfm, Accessed and 

printed on July 14, 2008. 

4. FDA Form No. 3480, Notification 

for New Use of a Food Contact 

Substance, Accessible at http:// 

www.fda.gov/downloads/AboutFDA/

ReportsManualsForms/Forms/

ucm076880.pdf, Accessed and printed 

on October 13, 2010. 

5. FDA, 2007, Nanotechnology Task 

Force Report 2007, Accessible at http:// 

www.fda.gov/ScienceResearch/Special

Topics/Nanotechnology/

NanotechnologyTaskForceReport2007/

default.htm, Accessed and printed on 

October 13, 2010. 

6. Guidance for Industry: Frequently 

Asked Questions About GRAS, 

Accessible at http://www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/GuidanceDocuments/Food

IngredientsandPackaging/

ucm061846.htm, Accessed and printed 

on October 13, 2010. 

Dated: December 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32344 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–132554–08] 

RIN 1545–BI16 

Additional Rules Regarding Hybrid 

Retirement Plans; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to a notice of 

proposed rulemaking. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
81544 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

SUMMARY: This document contains a 

correction to a notice of proposed 

rulemaking (REG–132554–08) that was 

published in the Federal Register on 

Tuesday, October 19, 2010 (75 FR 

64197) providing guidance relating to 

certain provisions of the Internal 

Revenue Code that apply to hybrid 

defined benefit pension plans. 

FOR FURTHER INFORMATION CONTACT: Neil 

S. Sandhu, Lauson C. Green, or Linda S. 

F. Marshall at (202) 622–6090 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The correction notice that is the 

subject of this document is under 

section 411 of the Internal Revenue 

Code. 

Need for Correction 

As published, the notice of proposed 

rulemaking (REG–132554–08) contains 

an error that may prove to be misleading 

and is in need of clarification. 

Correction of Publication 

Accordingly, the publication of the 

notice of proposed rulemaking (REG– 

132554–08), which was the subject of 

FR Doc. 2010–25942, is corrected as 

follows: 

§ 1.411(b)(5)–1 [Corrected] 

On page 64214, column 3, 

§ 1.411(b)(5)–1(e)(2)(iii)(A), line 19, the 

language ‘‘change the rate of interest 

crediting’’ is corrected to read ‘‘change 

the interest crediting rate’’. 

Guy R. Traynor, 

Acting Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel, Procedure and 

Administration. 

[FR Doc. 2010–32538 Filed 12–27–10; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 147 

Request for Information Regarding 

Value-Based Insurance Design in 

Connection With Preventive Care 

Benefits 

AGENCIES: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services. 

ACTION: Request for information. 

SUMMARY: This document contains a 

request for information on how group 

health plans and health insurance 

issuers can employ value-based 

insurance design in the coverage of 

recommended preventive services. 

DATES: Comments are due on or before 

February 28, 2011. 

ADDRESSES: Written comments may be 

submitted to any of the addresses 

specified below. Any comment that is 

submitted to any Department will be 

shared with the other Departments. 

Please do not submit duplicates. 

All comments will be made available 

to the public. Warning: Do not include 

any personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments may 

be posted on the Internet and can be 

retrieved by most Internet search 

engines. Comments may be submitted 

anonymously. 

Department of Labor. Comments to 

the Department of Labor, identified by 

VBID, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: E–OHPSCA– 

VBID.EBSA@dol.gov. 

• Mail or Hand Delivery: Office of 

Health Plan Standards and Compliance 

Assistance, Employee Benefits Security 

Administration, Room N–5653, U.S. 

Department of Labor, 200 Constitution 

Avenue, NW., Washington, DC 20210, 

Attention: VBID. 

Comments received by the 

Department of Labor will be posted 

without change to http:// 

www.regulations.gov and http:// 

www.dol.gov/ebsa, and available for 

public inspection at the Public 

Disclosure Room, N–1513, Employee 

Benefits Security Administration, 200 

Constitution Avenue, NW., Washington, 

DC 20210. 

Department of Health and Human 

Services. In commenting, please refer to 

file code HHS–OS–2010–002. Because 

of staff and resource limitations, we 

cannot accept comments by facsimile 

(FAX) transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

• Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

• By regular mail. You may mail 

written comments to the following 

address ONLY: Office of Consumer 

Information and Insurance Oversight, 

Department of Health and Human 

Services, Attention: HHS–OS–2010– 

002, Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

• By express or overnight mail. You 

may send written comments to the 

following address ONLY: Office of 

Consumer Information and Insurance 

Oversight, Department of Health and 

Human Services, Attention: HHS–OS– 

2010–002, Room 445–G, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

• By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to the following 

address: Office of Consumer Information 

and Insurance Oversight, Department of 

Health and Human Services, Attention: 

HHS–OS–2010–002, Room 445–G, 

Hubert H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the OCIIO drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 


emcdonald on DSK2BSOYB1PROD with PROPOSALS