77010 Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–29978 Filed 12–22–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 22, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0563. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice (OMB Control 

Number 0910–0563)—Extension 

The guidance is intended to provide 

information to manufacturers of 

veterinary and human drugs, including 

human biological drug products, on 

how to resolve disputes of scientific and 

technical issues relating to current good 

manufacturing practice (CGMP). 

Disputes related to scientific and 

technical issues may arise during FDA 

inspections of pharmaceutical 

manufacturers to determine compliance 

with CGMP requirements, or during 

FDA’s assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance provides 

procedures that encourage open and 

prompt discussion of disputes and lead 

to their resolution. The guidance 

describes procedures for raising such 

disputes to the Office of Regulatory 

Affairs (ORA) and center levels and for 

requesting review by the dispute 

resolution (DR) Panel. 

When a scientific or technical issue 

arises during an FDA inspection, the 

manufacturer should initially attempt to 

reach agreement on the issue informally 

with the investigator. Certain scientific 

or technical issues may be too complex 

or time consuming to resolve during the 

inspection. If resolution of a scientific or 

technical issue is not accomplished 

through informal mechanisms prior to 

the issuance of Form FDA 483, the 

manufacturer can formally request DR 

and can use the formal two-tiered DR 

process described in the guidance. 

Tier one of the formal DR process 

involves scientific or technical issues 

raised by a manufacturer to the ORA 

and center levels. If a manufacturer 

disagrees with the tier-one decision, 

tier-two of the formal DR process would 

then be available for appealing that 

decision to the DR panel. The written 

request for formal DR to the appropriate 

ORA unit should be made within 30 

days of the completion of an inspection, 

and should include all supporting 

documentation and arguments for 

review, as described in this document. 

The written request for formal DR to the 

DR Panel should be made within 60 

days of receipt of the tier-one decision 

and should include all supporting 

documentation and arguments, as 

described in the following paragraphs. 

All requests for formal DR should be 

in writing and include adequate 

information to explain the nature of the 

dispute and to allow FDA to act quickly 

and efficiently. Each request should be 

sent to the appropriate address listed in 

the guidance and include the following: 

• Cover sheet that clearly identifies 

the submission as either a request for 

tier-one DR or a request for tier-two DR; 

• name and address of manufacturer 

inspected (as listed on FDA Form 483); 

• date of inspection (as listed on 

Form FDA 483); 

• date Form FDA 483 issued (from 

Form FDA 483); 

• facility Establishment Identifier 

Number, if available (from Form FDA 

483); 

• FDA employee names and titles that 

conducted inspection (from Form FDA 

483); 

• office responsible for the inspection 

(e.g., district office, as listed on Form 

FDA 483); 

• application number if the 

inspection was a preapproval 

inspection; 

• comprehensive statement of each 

issue to be resolved: 

Æ Identify the observation in dispute; 

Æ clearly present the manufacturer’s 

scientific position or rationale 

concerning the issue under dispute with 

any supporting data; 

Æ state the steps that have been taken 

to resolve the dispute, including any 

informal DR that may have occurred 

before the issuance of Form FDA 483; 

Æ identify possible solutions; and 

Æ state expected outcome. 

• Name, title, telephone and FAX 

number, and email address (as 

available) of manufacturer contact. 

The guidance was initiated in 

response to industry’s request for a 

formal DR process to resolve differences 

related to scientific and technical issues 

that arise between investigators and 

pharmaceutical manufacturers during 

FDA inspections of foreign and 

domestic manufacturers. In addition to 

encouraging manufacturers to use 

currently available DR processes, the 

guidance describes the formal twotiered DR process explained previously. 

The guidance also covers the following 

topics: 

• The suitability of certain issues for 

the formal DR process, including 

examples of some issues with a 

discussion of their appropriateness for 

the DR process. 

• Instructions on how to submit 

requests for formal DR and a list of the 

supporting information that should 

accompany these requests. 

• Public availability of decisions 

reached during the DR process to 

promote consistent application and 

interpretation of drug quality-related 

regulations. 

Description of Respondents: 

Pharmaceutical manufacturers of 

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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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