Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 16237 

1. Description of Respondents: A 

sponsor or applicant for a drug or 

biological product who requests a 

formal meeting with the Agency 

regarding the development and review 

of a PDUFA product. 

2. Burden Estimate: Provided below is 

an estimate of the annual reporting 

burden for the submission of meeting 

requests and information packages 

under the guidance. 

C. Request For a Formal Meeting 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 975 sponsors and 

applicants (respondents) request 

approximately 2,014 formal meetings 

with CDER annually and approximately 

127 respondents request approximately 

253 formal meetings with CBER 

annually regarding the development and 

review of a PDUFA product. The hours 

per response, which is the estimated 

number of hours that a respondent 

would spend preparing the information 

to be submitted with a meeting request 

in accordance with the guidance, is 

estimated to be approximately 10 hours. 

Based on FDA’s experience, the Agency 

expects it will take respondents this 

amount of time to gather and copy brief 

statements about the product and a 

description of the purpose and details of 

the meeting. 

D. Information Package 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 756 respondents 

submitted approximately 1,394 

information packages to CDER annually 

and approximately 112 respondents 

submitted approximately 203 

information packages to CBER annually 

prior to a formal meeting regarding the 

development and review of a PDUFA 

product. The hours per response, which 

is the estimated number of hours that a 

respondent would spend preparing the 

information package in accordance with 

the guidance, is estimated to be 

approximately 18 hours. Based on 

FDA’s experience, the Agency expects it 

will take respondents this amount of 

time to gather and copy brief statements 

about the product, a description of the 

details for the anticipated meeting, and 

data and information that generally 

would already have been compiled for 

submission to the Agency. 

As stated earlier, the guidance 

provides information on how the 

Agency will interpret and apply section 

119(a) of FDAMA, specific PDUFA goals 

for the management of meetings 

associated with the review of human 

drug applications for PDUFA products, 

and provisions of existing regulations 

describing certain meetings (§§ 312.47 

and 312.82). The information collection 

provisions in § 312.47 concerning Endof-Phase 2 meetings and Pre-NDA 

meetings have been approved by OMB 

(OMB control number 0910–0014). 

However, the guidance provides 

additional recommendations for 

submitting information to FDA in 

support of a meeting request. As a 

result, FDA is submitting for OMB 

approval these additional estimates. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Meeting requests and information packages Number of respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

Meeting Requests 

CDER ................................................................................... 975 2.06 2,014 10 20,140 

CBER ................................................................................... 127 1.99 253 10 2,530 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,670 

Information Packages 

CDER ................................................................................... 756 1.84 1,394 18 25,092 

CBER ................................................................................... 112 1.81 203 18 3,654 

Total .............................................................................. ........................ ........................ ........................ ........................ 28,746 

Grand Total ............................................................ ........................ ........................ ........................ ........................ 51,416 

Dated: March 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6691 Filed 3–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0248] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution; Appeals Above the 

Division Level 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection contained in 

the guidance for industry on formal 

dispute resolution. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 21, 2012. 


srobinson on DSK4SPTVN1PROD with NOTICES
16238 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Dockets Management 

Branch (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA, 44 U.S.C. 3501–3520, Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry on Formal 

Dispute Resolution; Appeals Above the 

Division Level—(OMB Control Number 

0910–0430)—Extension 

This information collection approval 

request is for FDA guidance on the 

process for formally resolving scientific 

and procedural disputes in the Center 

for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) that 

cannot be resolved at the division level. 

The guidance describes procedures for 

formally appealing such disputes to the 

office or center level and for submitting 

information to assist center officials in 

resolving the issue(s) presented. The 

guidance provides information on how 

the Agency will interpret and apply 

provisions of the existing regulations 

regarding internal Agency review of 

decisions (§ 10.75 (21 CFR 10.75), 

dispute resolution during the 

investigational new drug (IND) process 

(§ 312.48 (21 CFR 312.48)), and the new 

drug application/abbreviated new drug 

application (NDA/ANDA) process 

(§ 314.103(21 CFR 314.103)). In 

addition, the guidance provides 

information on how the Agency will 

interpret and apply the specific 

Prescription Drug User Fee Act 

(PDUFA) goals for major dispute 

resolution associated with the 

development and review of PDUFA 

products. 

Existing regulations, which appear 

primarily in 21 CFR parts 10, 312, and 

314, establish procedures for the 

resolution of scientific and procedural 

disputes between interested persons and 

the Agency, CDER, and CBER. All 

Agency decisions on such matters are 

based on information in the 

administrative file (§ 10.75(d)). In 

general, the information in an 

administrative file is collected under 

existing regulations in part 312 (OMB 

control number 0910–0014), part 314 

(OMB control number 0910–0001), and 

part 601 (21 CFR part 601) (OMB control 

number 0910–0338), which specify the 

information that manufacturers must 

submit so that FDA may properly 

evaluate the safety and effectiveness of 

drugs and biological products. This 

information is usually submitted as part 

of an IND, NDA, or biologics license 

application (BLA), or as a supplement to 

an approved application. While FDA 

already possesses in the administrative 

file the information that would form the 

basis of a decision on a matter in 

dispute resolution, the submission of 

particular information regarding the 

request itself and the data and 

information relied on by the requestor 

in the appeal would facilitate timely 

resolution of the dispute. The guidance 

describes the following collection of 

information not expressly specified 

under existing regulations: The 

submission of the request for dispute 

resolution as an amendment to the 

application for the underlying product, 

including the submission of supporting 

information with the request for dispute 

resolution. 

Agency regulations (§§ 312.23(11)(d), 

314.50, 314.94, and 601.2) state that 

information provided to the Agency as 

part of an IND, NDA, ANDA, or BLA is 

to be submitted in triplicate and with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs and Form FDA 356h must 

accompany submissions under NDAs, 

ANDAs, and BLAs. Both forms have 

valid OMB control numbers as follows: 

FDA Form 1571—OMB control number. 

0910–0014 and FDA Form 356h—OMB 

control number 0910–0338. 

In the guidance document, CDER and 

CBER ask that a request for formal 

dispute resolution be submitted as an 

amendment to the application for the 

underlying product and that it be 

submitted to the Agency in triplicate 

with the appropriate form attached, 

either Form FDA 1571 or Form FDA 

356h. The Agency recommends that a 

request be submitted as an amendment 

in this manner for two reasons: To 

ensure that each request is kept in the 

administrative file with the entire 

underlying application and to ensure 

that pertinent information about the 

request is entered into the appropriate 

tracking databases. Use of the 

information in the Agency’s tracking 

databases enables the appropriate 

Agency official to monitor progress on 

the resolution of the dispute and to 

ensure that appropriate steps will be 

taken in a timely manner. 

CDER and CBER have determined and 

the guidance recommends that the 

following information should be 

submitted to the appropriate center with 

each request for dispute resolution so 

that the Center may quickly and 

efficiently respond to the request: (1) A 

brief but comprehensive statement of 

each issue to be resolved, including a 

description of the issue, the nature of 

the issue (i.e., scientific, procedural, or 

both), possible solutions based on 

information in the administrative file, 

whether informal dispute resolution 

was sought prior to the formal appeal, 

whether advisory committee review is 

sought, and the expected outcome; (2) a 

statement identifying the review 

division/office that issued the original 

decision on the matter and, if 

applicable, the last Agency official that 

attempted to formally resolve the 


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Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 16239 

matter; (3) a list of documents in the 

administrative file, or additional copies 

of such documents, that are deemed 

necessary for resolution of the issue(s); 

and (4) a statement that the previous 

supervisory level has already had the 

opportunity to review all of the material 

relied on for dispute resolution. The 

information that the Agency suggests 

submitting with a formal request for 

dispute resolution consists of: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute, (2) brief statements describing 

the history of the matter, and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the Agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the Agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance will be minimal. 

Description of respondents: A 

sponsor, applicant, or manufacturer of a 

drug or biological product regulated by 

the Agency under the Federal Food, 

Drug and Cosmetic Act or section 351 of 

the Public Health Service Act (42 U.S.C. 

262) (Pub. L. 99–660) who requests 

formal resolution of a scientific or 

procedural dispute. 

Burden Estimate: Provided below is 

an estimate of the annual reporting 

burden for requests for dispute 

resolution. Based on data collected from 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately nine sponsors and 

applicants (respondents) submit 

requests for formal dispute resolution to 

CDER annually and approximately one 

respondent submits requests for formal 

dispute resolution to CBER annually. 

The total annual responses are the total 

number of requests submitted to CDER 

and CBER in 1 year, including requests 

for dispute resolution that a single 

respondent submits more than one time. 

FDA estimates that CDER receives 

approximately 18 requests annually and 

CBER receives approximately 1 request 

annually. The hours per response is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted with a 

request for formal dispute resolution in 

accordance with this guidance, 

including the time it takes to gather and 

copy brief statements describing the 

issue from the perspective of the person 

with the dispute, brief statements 

describing the history of the matter, and 

supporting information that has already 

been submitted to the Agency. Based on 

experience, FDA estimates that 

approximately 8 hours on average 

would be needed per response. 

Therefore, FDA estimates that 152 hours 

will be spent per year by respondents 

requesting formal dispute resolution 

under the guidance. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Requests for formal dispute resolution Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER ................................................................................... 9 2 18 8 144 

CBER ................................................................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 152 

Dated: March 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6690 Filed 3–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0389] 

Medical Device User Fee Act; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss proposed 

recommendations for the 

reauthorization of the Medical Device 

User Fee Act (MDUFA) for fiscal years 

(FYs) 2013 through 2017. MDUFA 

authorizes FDA to collect user fees and 

use them for the process for the review 

of medical device applications. The 

current legislative authority for MDUFA 

expires on October 1, 2012. New 

legislation will be required for FDA to 

collect medical device user fees for 

future FYs. Following discussions with 

the device industry and periodic 

consultations with public stakeholders, 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) directs FDA to publish 

the recommendations for the 

reauthorized program in the Federal 

Register, hold a meeting at which the 

public may present its views on such 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations. FDA will then 

consider such public views and 

comments and revise such 

recommendations as necessary. 

DATES: The public meeting will be held 

on March 28, 2012 from 9 a.m. to 5 p.m. 

Registration to attend the meeting must 

be received by March 26, 2012. Submit 

either electronic or written comments 

by April 16, 2012. 

Location: The meeting will be held at 

the Hubert H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. For directions 

and metro information please visit the 

following Web site: http://www.hhs.gov/ 

about/hhhmap.html. The public 

meeting will also be available to be 

viewed online via webcast. Registration 

is required to view the webcast. 

Contact Person: Cindy Garris, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave. Bldg. 66, Rm. 

4459, Silver Spring, MD 20993, 301– 

796–5861, FAX: 301–847–8142, email: 

MDUFAReauthorization@fda.hhs.gov. 

Registration and Oral Presentations: If 

you wish to attend and/or speak at the 

meeting or view the webcast, please 

register by March 26, 2012. To register 

for the meeting, please visit http://www.

fda.gov/MedicalDevices/NewsEvents/

WorkshopsConferences/default.htm (or 

go to the FDA Medical Devices News & 

Events—Workshops & Conferences 

calendar and select this public meeting 

from the posted events list). Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email address, and 

phone number. Registrants wishing to 

speak during the open comment period 

should note that when registering. We 


srobinson on DSK4SPTVN1PROD with NOTICES