Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 77011 

veterinary and human drug products 

and human biological drug products. 

FDA estimates that approximately two 

manufacturers will submit 

approximately two requests annually for 

a tier-one DR and that there will be one 

appeal of these requests to the DR Panel 

(request for tier-two DR). FDA estimates 

that it will take manufacturers 

approximately 30 hours to prepare and 

submit each request for a tier-one DR 

and approximately 8 hours to prepare 

and submit each request for a tier-two 

DR. Table 1 provides an estimate of the 

annual reporting burden for requests for 

tier-one and tier-two DRs. 

In the Federal Register of August 11, 

2014 (79 FR 46836), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Requests for Tier-One DR ................................................... 2 1 2 30 60 

Requests for Tier-Two DR ................................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 68 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: December 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29917 Filed 12–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1104] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

State Petitions for Exemption From 

Preemption 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘State Petitions for Exemption from 

Preemption’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

October 27, 2014, the Agency submitted 

a proposed collection of information 

entitled ‘‘State Petitions for Exemption 

from Preemption’’ to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0277. The 

approval expires on November 30, 2017. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: December 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30012 Filed 12–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0588] 

Compliance Policy Guide Sec. 540.700 

Labeling of Processed and Blended 

Seafood Products Made Primarily With 

Fish Protein; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of 

Compliance Policy Guide Sec. 540.700 

Labeling of Processed and Blended 

Seafood Products Made Primarily with 

Fish Protein (the CPG). The CPG 

provides guidance for our staff on our 

labeling requirements for processed and 

blended seafood products made 

primarily with fish protein. 

DATES: Submit either electronic or 

written comments on FDA’s CPGs at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the CPG to the Office of 

Policy and Risk Management, Office of 

Regulatory Affairs, Office of Global 

Regulatory Operations and Policy, Food 

and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the CPG. 

Submit electronic comments on the 

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

Submit written comments on the CPG to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Catalina Ferre-Hockensmith, Center for 

Food Safety and Applied Nutrition 

(HFC–820), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

revised Compliance Policy Guide Sec. 

540.700 Labeling of Processed and 

Blended Seafood Products Made 

Primarily with Fish Protein. We are 

issuing the revisions to the CPG as Level 

2 guidance under our good guidance 

practices regulation (21 CFR 10.115). 

Consistent with our good guidance 

practices regulation, we will accept 

comments on the CPG at any time. The 

CPG represents our 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 alternate approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

The CPG updates previously issued 

CPG Sec. 540.700 Processed and/or 

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