6998 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

number 0910–0485; the collections of 

information in 21 CFR part 803 are 

approved under OMB control numbers 

0910–0437 and 0910–0291; the 

collections of information in 21 CFR 

part 806 are approved under OMB 

control number 0910–0359; the 

collections of information in 21 CFR 

part 807 subparts B and C are approved 

under OMB control number 0910–0625; 

the collections of information in 21 CFR 

part 807 subpart E are approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 812 are approved under OMB 

control number 0910–0078; the 

collections of information in 21 CFR 

part 814 subparts A through E are 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 820 are 

approved under OMB control number 

0910–0073; and the collections of 

information regarding section 513(g) of 

the FD&C Act (21 U.S.C. 360c(g)) are 

approved under OMB control number 

0910–0705. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 4, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02573 Filed 2–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–D–0500 (Formerly 

Docket No. 2004D–0042)] 

Brief Summary and Adequate 

Directions for Use: Disclosing Risk 

Information in Consumer-Directed 

Print Advertisements and Promotional 

Labeling for Human Prescription 

Drugs; Revised Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘Brief Summary 

and Adequate Directions for Use: 

Disclosing Risk Information in 

Consumer-Directed Print 

Advertisements and Promotional 

Labeling for Human Prescription 

Drugs.’’ This revised draft guidance, 

when finalized, will assist 

manufacturers, packers, and distributors 

(firms) of human prescription drugs and 

biologics with meeting the brief 

summary requirement for prescription 

drug advertising and the requirement 

that adequate directions for use be 

included with promotional labeling for 

prescription drugs when print materials 

are directed toward consumers. FDA is 

also announcing the withdrawal of the 

draft guidance for industry entitled 

‘‘Brief Summary: Disclosing Risk 

Information in Consumer-Directed Print 

Advertisements.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this 

revised draft guidance before it begins 

work on the final version of the 

guidance, submit either electronic or 

written comments on the revised draft 

guidance by May 11, 2015. Submit 

either electronic or written comments 

on the proposed collection of 

information by April 10, 2015. 

ADDRESSES: Submit written requests for 

single copies of the revised draft 

guidance to the Division of Drug 

Information, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 2201, Silver Spring, 

MD 20993–0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the revised draft guidance 

document. 

Submit electronic comments on the 

revised draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Regarding human prescription drugs: 

Julie Chronis, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Silver Spring, 

MD 20993–0002, 301–796–1200. 

Regarding human prescription 

biological products: Stephen Ripley, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Brief Summary and Adequate 

Directions for Use: Disclosing Risk 

Information in Consumer-Directed Print 

Advertisements and Promotional 

Labeling for Human Prescription 

Drugs.’’ This revised draft guidance 

updates prior FDA policy and describes 

the Agency’s current thinking regarding 

the brief summary requirement for 

consumer-directed print prescription 

drug advertisements. Specifically, the 

revised draft guidance includes 

recommendations for developing a 

consumer brief summary and notes that, 

so long as firms include appropriate 

information in a print advertisement as 

outlined in the revised draft guidance, 

FDA does not intend to object for a 

failure to include certain other 

information. 

Additionally, this revised draft 

guidance provides new 

recommendations regarding the 

adequate directions for use requirement 

for consumer-directed print promotional 

labeling for prescription drug products. 

Although the requirement in 21 CFR 

201.100(d) for firms to provide adequate 

information for use is generally fulfilled 

by providing the full FDA-approved 

package insert (PI), this revised draft 

guidance provides that, in exercising its 

enforcement discretion, FDA does not 

intend to object for failure to include the 

full PI with consumer-directed print 

promotional labeling pieces if firms 

include the appropriate information as 

outlined in the revised draft guidance, 

i.e., the same information in the 

consumer brief summary. This 

recommendation is designed to 

standardize the information consumers 

receive in print prescription drug 

product advertisements and 

promotional labeling and to make 

information more understandable to 

consumers. 

FDA issued a draft guidance in the 

Federal Register of February 10, 2004 

(69 FR 6308), entitled ‘‘Brief Summary: 

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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6999 

Disclosing Risk Information in 

Consumer-Directed Print 

Advertisements.’’ FDA requested 

comments on whether the draft 

guidance provided sufficient guidance 

on the content of the consumer brief 

summary and also requested research 

results on potential formats for the 

consumer brief summary. Comments, 

suggestions, and research were 

submitted to Docket No. 2004D–0042 

and were carefully analyzed and 

considered before developing this 

revised draft guidance. 

This revised draft guidance 

incorporates information from recent 

social science research, clarifies the risk 

information that should be included in 

the consumer brief summary, and 

recommends several formatting options 

for this information. The revised draft 

guidance also recommends the use of 

consumer-friendly language and visual 

techniques to improve accessibility for 

consumers. Additionally, this revised 

draft guidance recommends that firms 

not disseminate the full PI to fulfill the 

requirements in § 201.100(d) for 

consumer-directed print promotional 

labeling for prescription drugs. Rather, 

the revised draft guidance recommends 

that firms provide the same content and 

format created for the consumer brief 

summary. FDA is issuing this revised 

guidance as a draft to allow for public 

comment on the recommendations. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulations (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent FDA’s 

current thinking on the brief summary 

and adequate directions for use 

requirements. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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. 

This revised draft guidance also refers to 

previously approved collection of 

information found in FDA regulations. 

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 collected; and (4) ways to 

minimize the burden of information 

collected on the respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Brief Summary and Adequate 

Directions for Use: Disclosing Risk 

Information in Consumer-Directed Print 

Advertisements and Promotional 

Labeling for Human Prescription Drugs. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors (firms) of prescription 

human drug products, including 

biological products. 

Burden Estimate: The revised draft 

guidance pertains to the brief summary 

requirement for prescription drug 

advertising and the requirement that 

adequate directions for use be included 

with promotional labeling for human 

prescription drugs when print materials 

are directed toward consumers. 

The revised draft guidance, in part, 

explains FDA’s current policy position 

that FDA does not intend to object for 

failure to include the entire PI to fulfill 

the requirements of § 201.100(d) for 

promotional labeling pieces directed 

toward consumers, if firms instead 

provide information on the most serious 

and the most common risks associated 

with the product, while omitting less 

important information. Specifically, 

FDA recommends that any Boxed 

Warning, all Contraindications, certain 

information regarding Warnings and 

Precautions (i.e., the most clinically 

significant information from the 

Warnings and Precautions section of the 

PI, information that would affect a 

decision to prescribe or take a drug, 

monitoring or laboratory tests that may 

be needed, special precautions not set 

forth in other parts of the PI, and 

measures that can be taken to prevent or 

mitigate harm), and the most frequently 

occurring Adverse Reactions should be 

included. 

Furthermore, FDA recommends that 

information should include the 

indication for the use being promoted. 

Information regarding patient directives 

(such as ‘‘discuss with your health care 

provider any pre-existing conditions’’ or 

‘‘tell your health care provider if you are 

taking any medications’’) should also be 

included. Other types of information 

may be included if relevant to the drug 

or specific indication referred to in the 

promotional material(s). A statement 

should be included that more 

comprehensive information can be 

obtained from various sources, 

including the firm. 

Thus, the revised draft guidance 

recommends that firms disclose certain 

information to others in place of the PI 

to fulfill the requirements in 

§ 201.100(d). This ‘‘third-party 

disclosure’’ constitutes a ‘‘collection of 

information’’ under the PRA. 

FDA estimates that approximately 400 

firms disseminate 24,000 consumerdirected print promotional labeling 

pieces annually. FDA estimates that it 

will take firms approximately 10 hours 

to compile and draft the information 

needed to provide the information 

recommended in the revised draft 

guidance. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Adequate information for use: disclosing risk 

information in consumer-directed promotional 

labeling 

Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Hours per 

disclosure Total hours 

Disclosures Related to Adequate Information 

for Use (§ 201.100(d)) .................................. 400 60 24,000 10 240,000 

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

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7000 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

This revised draft guidance also refers 

to previously approved collections of 

information found in FDA regulations 

with respect to the brief summary 

requirement. These collections of 

information are subject to review by 

OMB under the PRA. The collection of 

information in 21 CFR 202.1 has been 

approved under OMB control number 

0910–0686. 

III. Comments 

In addition to general comments, FDA 

specifically requests comments on the 

following issues: 

• In the revised draft guidance, FDA 

provides recommendations regarding 

the content and format of the consumer 

brief summary. Is this the most useful 

information for consumers to use in 

determining whether to take a 

medication or seek more information 

about a product, and if not, what 

information would be more useful? 

• FDA is also interested in relevant 

research that has been conducted or 

alternative formats that were developed 

after we received comments on the 2004 

draft guidance. 

• In the revised draft guidance, FDA 

suggests that the adequate directions for 

use requirement be fulfilled by 

providing the consumer brief summary 

rather than the full PI for the product. 

FDA seeks comments regarding this 

recommendation. 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: February 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02527 Filed 2–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Joint Meeting of the Pulmonary-Allergy 

Drugs Advisory Committee and the 

Drug Safety and Risk Management 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: PulmonaryAllergy Drugs Advisory Committee and 

the Drug Safety and Risk Management 

Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 19, 2015, from 8 a.m. to 

5 p.m. 

Location: Holiday Inn Gaithersburg 

Ballroom, 2 Montgomery Village Ave., 

Gaithersburg, MD 20879. The hotel 

telephone number is 301–948–8900. 

Contact Person: Cindy Hong, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, 

PADAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

Agenda: The committees will discuss 

supplemental new drug application 

204275–S001, for fluticasone furoate 

and vilanterol inhalation powder 

(tradename Breo Ellipta) submitted by 

GlaxoSmithKline for the once daily 

maintenance treatment of asthma in 

patients 12 years of age and older. The 

discussion will include efficacy data, 

but the focus of the meeting will be 

safety, including the adequacy of the 

safety database to support approval, and 

whether a large safety trial to evaluate 

serious asthma outcomes is 

recommended. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 5, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

25, 2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 26, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Cindy Hong 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

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