Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 16235 

Prescribing Information.’’ Highlights 

provides a concise extract of the most 

important information required under 

§ 201.57(c) (the Full Prescribing 

Information (FPI)), as well as certain 

additional information important to 

prescribers. Section 201.57(b) requires a 

table of contents to prescribing 

information, entitled ‘‘Full Prescribing 

Information: Contents,’’ consisting of a 

list of each heading and subheading 

along with its identifying number to 

facilitate health care practitioners’ use 

of labeling information. Section 

201.57(c) specifies the contents of the 

FPI. Section 201.57(d) mandates the 

minimum specifications for the format 

of prescription drug labeling and 

establishes minimum requirements for 

key graphic elements such as bold type, 

bullet points, type size, and spacing. 

Older drugs not subject to the revised 

labeling content and format 

requirements in § 201.57 remain subject 

to labeling requirements at § 201.80 (in 

the final rule, former § 201.57 was 

redesignated as § 201.80). Section 

201.80(f)(2) requires that within 1 year, 

any FDA-approved patient labeling be 

referenced in the ‘‘Precautions’’ section 

of the labeling of older products and 

either accompany or be reprinted 

immediately following the labeling. 

B. Estimates of Reporting Burden 

The PRA information collection 

analysis in the final rule (71 FR 3964– 

3967) (currently approved under OMB 

control number 0910–0572) estimated 

the reporting burden for a multiyear 

period. We are requesting that OMB 

extend approval for the information in 

this collection, as described below that 

will continue to be submitted to FDA 

during this multiyear period. 

Annual Burden for Prescription Drug 

Labeling Design, Testing, and 

Submitting to FDA for New Drug 

Applications (NDAs) and Biologics 

License Applications (BLAs) (§§ 201.56 

and 201.57) (Table 1) 

New drug product applicants must: 

(1) Design and create prescription drug 

labeling containing Highlights, 

Contents, and FPI, (2) test the designed 

labeling (e.g., to ensure that the 

designed labeling fits into cartonenclosed products), and (3) submit it to 

FDA for approval. Based on the 

projected data estimated in the final 

rule, FDA estimates that it takes 

applicants approximately 3,349 hours to 

design, test, and submit prescription 

drug labeling to FDA as part of an NDA 

or a BLA under the revised regulations. 

Approximately 84 applicants submit 

approximately 105 new applications 

(NDAs and BLAs) to FDA per year, 

totaling 351,645 hours. 

In the Federal Register of December 

19, 2011 (76 FR 78668), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received no 

comments. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED REPORTING BURDEN FOR NEW DRUG APPLICATIONS 1

Category 

(21 CFR section) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Annual Burden for Labeling Requirements in §§ 201.56 

and 201.57 ....................................................................... 84 1.25 105 3,349 351,645 

Total .............................................................................. ........................ ........................ ........................ ........................ 351,645 

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

Dated: March 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6693 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–0247] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Meetings With 

Sponsors and Applicants for 

Prescription Drug User Fee Act 

Products 

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 

meetings with sponsors and applicants 

for Prescription Drug User Fee Act 

(PDUFA) products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 21, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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, 


srobinson on DSK4SPTVN1PROD with NOTICES
16236 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 

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 

Meetings With Sponsors and 

Applicants for PDUFA Products—(OMB 

Control Number 0910–0429)—Extension 

This information collection approval 

request is for FDA guidance on the 

procedures for formal meetings between 

FDA and sponsors or applicants 

regarding the development and review 

of PDUFA products. The guidance 

describes procedures for requesting, 

scheduling, conducting, and 

documenting such formal meetings. The 

guidance provides information on how 

the Agency will interpret and apply 

section 119(a) of the Food and Drug 

Administration Modernization Act of 

1997 (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 (21 CFR 312.47 and 312.82)). 

The guidance describes two 

collections of information: The 

submission of a meeting request 

containing certain information and the 

submission of an information package in 

advance of the formal meeting. Agency 

regulations at §§ 312.47(b)(1)(ii), 

(b)(1)(iv), and (b)(2) describe 

information that should be submitted in 

support of a request for an End-of-Phase 

2 meeting and a Pre-NDA meeting. The 

information collection provisions of 

§ 312.47 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 additional 

estimates for OMB approval. 

A. Request for a Meeting 

Under the guidance, a sponsor or 

applicant interested in meeting with the 

Center for Drug Evaluation and Research 

(CDER) or the Center for Biologics 

Evaluation and Research (CBER) should 

submit a meeting request to the 

appropriate FDA component as an 

amendment to the underlying 

application. FDA regulations (§§ 312.23, 

314.50, and 601.2 (21 CFR 312.23, 

314.50, and 601.2)) state that 

information provided to the Agency as 

part of an Investigational New Drug 

Application (IND), New Drug 

Application (NDA), or Biological 

License Application (BLA) must be 

submitted with an appropriate cover 

form. Form FDA 1571 must accompany 

submissions under INDs and Form FDA 

356h must accompany submissions 

under NDAs 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 a formal 

meeting be submitted as an amendment 

to the application for the underlying 

product under the requirements of 

§§ 312.23, 314.50, and 601.2; therefore, 

requests should be submitted to the 

Agency with the appropriate form 

attached, either Form FDA 1571 or Form 

FDA 356h. The Agency recommends 

that a request be submitted in this 

manner for two reasons: (1) To ensure 

that each request is kept in the 

administrative file with the entire 

underlying application and (2) 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 Agency to monitor 

progress on the activities attendant to 

scheduling and holding a formal 

meeting and to ensure that appropriate 

steps will be taken in a timely manner. 

Under the guidance, the Agency 

requests that sponsors and applicants 

include in meeting requests certain 

information about the proposed 

meeting. Such information includes: 

• Information identifying and 

describing the product; 

• The type of meeting being 

requested; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes from the meeting; 

• A preliminary proposed agenda; 

• A draft list of questions to be raised 

at the meeting; 

• A list of individuals who will 

represent the sponsor or applicant at the 

meeting; 

• A list of Agency staff requested to 

be in attendance; 

• The approximate date that the 

information package will be sent to the 

Agency; and 

• Suggested dates and times for the 

meeting. 

This information will be used by the 

Agency to determine the utility of the 

meeting, to identify Agency staff 

necessary to discuss proposed agenda 

items, and to schedule the meeting. 

B. Information Package 

A sponsor or applicant submitting an 

information package to the Agency in 

advance of a formal meeting should 

provide summary information relevant 

to the product and supplementary 

information pertaining to any issue 

raised by the sponsor, applicant, or 

Agency. The Agency recommends that 

information packages generally include: 

• Identifying information about the 

underlying product; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes of the meeting; 

• A proposed agenda for the meeting; 

• A list of specific questions to be 

addressed at the meeting; 

• A summary of clinical data that will 

be discussed (as appropriate); 

• A summary of preclinical data that 

will be discussed (as appropriate); and 

• Chemistry, manufacturing, and 

controls information that may be 

discussed (as appropriate). 

The purpose of the information 

package is to provide Agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. 

Although FDA reviews similar 

information in the meeting request, the 

information package should provide 

updated data that reflect the most 

current and accurate information 

available to the sponsor or applicant. 

The Agency finds that reviewing such 

information is critical to achieving a 

productive meeting. 

The collection of information 

described in the guidance reflects the 

current and past practice of sponsors 

and applicants to submit meeting 

requests as amendments to INDs, NDAs, 

and BLAs and to submit background 

information prior to a scheduled 

meeting. Agency regulations currently 

permit such requests and recommend 

the submission of an information 

package before an End-of-Phase 2 

meeting (§§ 312.47(b)(1)(ii) and 

(b)(1)(iv)) and a Pre-NDA meeting 

(§ 312.47(b)(2)). 


srobinson on DSK4SPTVN1PROD with NOTICES
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