16234 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

310.305(c)(5) ........................................................................ 3 1 3 1 3 

314.80(c)(1)(iii) ..................................................................... 5 1 5 1 5 

314.80(c)(2) .......................................................................... 665 22.85 15,195 60 911,700 

Total .............................................................................. ........................ ........................ ........................ ........................ 911,708 

1The reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) is reported under OMB control number 0910– 

0291. The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

310.305(f) ............................................................................. 25 1 25 16 400 

314.80(i) ............................................................................... 665 601.5 399,998 16 6,399,968 

Total .............................................................................. ........................ ........................ ........................ ........................ 6,400,368 

1There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually. 

These estimates are based on FDA’s 

knowledge of adverse drug experience 

reporting, including the time needed to 

prepare the reports, and the number of 

reports submitted to the Agency. 

Dated: March 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6692 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–2011–N–0883] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

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 April 19, 

2012. 

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 0910–0572. Also 

include the FDA 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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products—(OMB Control 

Number 0910–0572)—(Extension) 

FDA’s final rule entitled 

‘‘Requirements on Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products’’ (the final 

rule), which published on January 24, 

2006 (71 FR 3922), and was effective on 

June 30, 2006, amended FDA’s 

regulations governing the format and 

content of labeling for human 

prescription drug and biological 

products to require that the labeling of 

new and recently approved products 

contain highlights of prescribing 

information, a table of contents for 

prescribing information, reordering of 

certain sections, minor content changes, 

and minimum graphical requirements. 

These revisions were intended to make 

it easier for health care practitioners to 

access, read, and use information in 

prescription drug labeling; to enhance 

the safe and effective use of prescription 

drug products; and to reduce the 

number of adverse reactions resulting 

from medication errors due to 

misunderstood or incorrectly applied 

drug information. 

A. Summary of Prescription Drug 

Labeling Content and Format 

Requirements That Contain Collections 

of Information 

Section 201.56 (21 CFR 201.56) 

requires that prescription drug labeling 

contain certain information in the 

format specified in either § 201.57 (21 

CFR 201.57) or § 201.80 (21 CFR 

201.80), depending on when the drug 

was approved for marketing. Section 

201.56(a) sets forth general labeling 

requirements applicable to all 

prescription drugs. Section 201.56(b) 

specifies the categories of new and more 

recently approved prescription drugs 

subject to the revised content and 

format requirements in §§ 201.56(d) and 

201.57. Section 201.56(c) sets forth the 

schedule for implementing these revised 

content and format requirements. 

Section 201.56(e) specifies the sections 

and subsections, required and optional, 

for the labeling of older prescription 

drugs not subject to the revised format 

and content requirements. 

Section 201.57(a) requires that 

prescription drug labeling for new and 

more recently approved prescription 

drug products include ‘‘Highlights of 


srobinson on DSK4SPTVN1PROD with NOTICES
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