39598 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

S. Tissue Engineering 

15–50 ................................... Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds .......... ASTM F2739–16. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the current list of FDA 

Recognized Consensus Standards in a 

searchable database that may be 

accessed at https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will be incorporating the modifications 

and revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will be announcing additional 

modifications and revisions to the list of 

recognized consensus standards in the 

Federal Register, as needed, once a 

year, or more often if necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to 

CDRHStandardsStaff@fda.hhs.gov. To 

be considered, such recommendations 

should contain, at a minimum, the 

following information: (1) Title of the 

standard, (2) any reference number and 

date, (3) name and electronic or mailing 

address of the requestor, (4) a proposed 

list of devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

Dated: August 16, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17603 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–2936] 

Content of Risk Information in the 

Major Statement in Prescription Drug 

Direct-to-Consumer Broadcast 

Advertisements; Establishment of a 

Public Docket; Request for Information 

and Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for information 

and comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is establishing a public docket to 

assist with its development of 

recommendations regarding the 

communication of risk information in 

direct-to-consumer (DTC) broadcast 

advertisements for prescription drugs 

and biologics. 

DATES: Although you can comment at 

any time, to ensure that the Agency 

considers your comment in our 

development of recommendations, 

submit either electronic or written 

information and comments by 

November 20, 2017. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–2936 for ‘‘Content of Risk 

Information in the Major Statement in 

Prescription Drug Direct-to-Consumer 

Broadcast Advertisements.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39599 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 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, Rm. 3203, 

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 

The prescription drug advertising 

regulations require that broadcast 

advertisements containing product 

claims include information relating to 

the advertised drug’s major side effects 

and contraindications in either the 

audio or audio and visual parts of the 

advertisement (21 CFR 202.1(e)(1)); this 

is often called the major statement. The 

regulations also require that broadcast 

advertisements contain a brief summary 

of all necessary information related to 

side effects and contraindications or 

that ‘‘adequate provision’’ be made for 

dissemination of the approved package 

labeling in connection with the 

broadcast presentation (21 CFR 

202.1(e)(1)). This requirement to make 

‘‘adequate provision’’ is generally 

fulfilled when a firm gives consumers 

the option of obtaining the FDArequired labeling or other information 

via a toll-free telephone number, 

through print advertisements or product 

brochures, through information 

disseminated at health care provider 

offices or pharmacies, and through the 

internet. See the guidance for industry 

entitled ‘‘Consumer-Directed Broadcast 

Advertisements,’’ available at http://

www.fda.gov/ForIndustry/ 

FDABasicsforIndustry/ucm234622.htm. 

From a public health standpoint, FDA 

is interested in helping to ensure that 

when firms choose to advertise directly 

to consumers and patients, such 

advertisements provide clear and useful 

information to that audience. There is 

concern that the major statement, as 

currently implemented in DTC 

broadcast advertisements for 

prescription drugs, is not fulfilling this 

purpose. Some believe it is often too 

long, which may result in reduced 

consumer comprehension, minimization 

of important risk information, and, 

potentially, therapeutic noncompliance 

caused by fear of side effects (Ref. 1). At 

the same time, there is concern that DTC 

broadcast advertisements do not include 

adequate risk information or that they 

leave out important information (Refs. 2 

and 3). 

The Office of Prescription Drug 

Promotion (OPDP) within FDA’s Center 

for Drug Evaluation and Research 

(CDER) is investigating through 

empirical research the effectiveness of a 

limited risks plus disclosure strategy to 

inform the Agency’s decision making in 

this area. (For more information about 

OPDP’s proposed study, see 79 FR 9217, 

February 18, 2014.) Through the 

research and through this request for 

information and comments, OPDP is 

exploring the usefulness of limiting the 

risks in the major statement for most 

DTC broadcast advertisements for 

prescription drugs to those that are 

severe (life-threatening), serious, or 

actionable, coupled with a disclosure to 

alert consumers that there are other 

product risks not included in the 

advertisement. (For example, a 

disclosure could be, ‘‘This is not a full 

list of risks and side effects. Talk to your 

health care provider and read the 

patient labeling for more information.’’) 

For the purposes of this request for 

information and comments, please 

consider the following definitions: 

• Severe risk—a serious risk that is 

life-threatening (see serious risk). 

• Serious risk—the risk of reactions 

from using the drug that may result in 

inpatient hospitalization or prolonged 

existing hospitalization, a persistent or 

significant disability or incapacity, or a 

congenital anomaly or birth defect. 

Reactions that do not require 

hospitalization, cause a disability, or 

cause a birth defect may still be 

considered serious risks when, based on 

appropriate medical judgment, they may 

jeopardize the patient and may require 

medical or surgical intervention to 

prevent one of the outcomes previously 

listed. 

• Actionable risk—a risk the patient 

would know (e.g., pre-existing condition 

or allergy) or recognize (e.g., observable 

physical or mental symptom) and can 

act upon to help mitigate the risk (e.g., 

get immediate medical help to prevent 

a bad outcome); for example, ‘‘Stop 

using the product and get immediate 

medical help if you have swelling of the 

face, lips, tongue, or throat.’’ 

However, we note that while some 

drug products may not have severe, 

serious, or actionable risks as described 

in this document, all DTC prescription 

drug broadcast advertisements are 

required to present a fair balance of risk 

information when presenting 

information relating to the effectiveness 

of the drug (21 CFR 202.1(e)(5)). 

Therefore, to avoid a misleading 

presentation regarding a drug’s riskbenefit profile, prescription drug 

advertisements that provide information 

about a drug’s effectiveness would be 

expected to contain some risk 

information, even if the risks are not 

severe, serious, or actionable. 

II. Request for Information and 

Comments 

Interested persons are invited to 

provide detailed information and 

comments on the content of risk 

information in DTC broadcast 

advertisements for prescription drugs. 

FDA is particularly interested in 

responses to the following questions: 

1. What data are available regarding 

the impact of the current approaches to 

communication of risk information in 

DTC prescription drug broadcast 

advertisements on consumer 

comprehension of the information in the 

advertisement, including the impact on 

comprehension of product benefits and 

risk information? 

2. What are the potential effects of 

only including risks from the FDAapproved product labeling that are 

severe, serious, or actionable (as 

previously defined) in the major 

statements of DTC prescription drug 

broadcast advertisements? Are there 

other ways of characterizing which risks 

should be included in the major 

statement? Please explain. 

3. When a DTC prescription drug 

broadcast advertisement presents 

information relating to the effectiveness 

of a prescription drug that does not have 

severe, serious, or actionable risks, what 

types of risk could be included in the 

major statement? 

4. What criteria should be used to 

distinguish risk information that is most 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39600 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

material to patient or consumer 

audiences versus risk information that is 

material primarily to the prescriber or 

other health care providers? What data 

are available to answer this question? 

5. What criteria should be used to 

determine which risk information that is 

material to patient or consumer 

audiences to include in the major 

statement for DTC prescription drug 

broadcast advertisements to best protect 

the public health? What data are 

available to answer this question? 

6. What is the potential impact of 

including (or conversely, of not 

including), in the major statement for 

DTC prescription drug broadcast 

advertisements, additional language that 

states that there are other risks not 

included in the advertisement while 

simultaneously encouraging dialogue 

between patients and their health care 

providers? (For example, additional 

language could include, ‘‘This is not a 

full list of risks and side effects. Talk to 

your health care provider and read the 

patient labeling for more information.’’) 

What data are available to answer this 

question? 

7. What data are available on 

consumers’ comprehension of the 

difference between levels (i.e., severity) 

of risk? Would it be in the interest of 

public health to include a signal before 

the risk information that frames and 

categorizes the overall level of risk 

associated with the product? One 

approach may be to include an opening 

statement tailored to the risk profile of 

the drug. For example, drugs could be 

divided into three defined categories 

and include the corresponding opening 

statements: 

a. For drugs with severe, lifethreatening risks: ‘‘[Drug] can cause 

severe, life-threatening reactions. These 

include . . . .’’ 

b. For drugs with serious but not lifethreatening risks: ‘‘[Drug] can cause 

serious reactions. These include . . . .’’ 

c. For drugs with no severe or serious 

risks: ‘‘[Drug] can cause reactions. These 

include . . . .’’ 

8. Should potential food and drug 

interactions be disclosed in DTC 

prescription drug broadcast 

advertisements, and if so, what criteria 

should be used to identify these 

interactions? 

FDA will consider all information and 

comments submitted. 

III. References 

The following references are on 

display in the Dockets Management 

Staff office (see ADDRESSES) and are 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. 

1. Delbaere, M. and M.C. Smith, ‘‘Health 

Care Knowledge and Consumer Learning: 

The Case of Direct-to-Consumer Drug 

Advertising,’’ Health Marketing Quarterly, 

vol. 23, issue 3, pp. 9–29, 2006. 

2. Friedman, M. and J. Gould, ‘‘Consumer 

Attitudes and Behaviors Associated With 

Direct-to-Consumer Prescription Drug 

Marketing,’’ Journal of Consumer Marketing, 

vol. 24, issue 2, pp. 100–109, 2007. 

3. Frosch, D.L., P.M. Krueger, R.C. Hornik, 

P.F. Cronholm, and F.K. Barg, ‘‘Creating 

Demand for Prescription Drugs: A Content 

Analysis of Television Direct-to-Consumer 

Advertising,’’ The Annals of Family 

Medicine, vol. 5, issue 1, pp. 6–13, 2007. 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17563 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal of the National 

Vaccine Advisory Committee 

AGENCY: National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services is hereby giving notice 

that the charter for the National Vaccine 

Advisory Committee (NVAC) has been 

renewed. 

FOR FURTHER INFORMATION CONTACT: 

National Vaccine Program Office, U.S. 

Department of Health and Human 

Services, Room 715H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

Phone: (202) 690–5566; email: nvac@

hhs.gov. 

SUPPLEMENTARY INFORMATION: NVAC is a 

non-discretionary Federal advisory 

committee. The establishment of NVAC 

was mandated under Section 2105 (42 

U.S.C. Section 300aa–5) of the Public 

Health Service Act, as amended (PHS 

Act). The Committee is governed by 

provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, as amended (5 U.S.C. App.). NVAC 

advises and makes recommendations to 

the Director, National Vaccine Program 

(NVP), on matters related to the 

Program’s responsibilities. The 

Assistant Secretary for Health is 

appointed to serve as the Director, NVP. 

To carry out its mission, NVAC (1) 

studies and recommends ways to 

encourage the availability of an 

adequate supply of safe and effective 

vaccination products in the United 

States; (2) recommends research 

priorities and other measures the 

Director of the NVP should take to 

enhance the safety and efficacy of 

vaccines; (3) advises the Director of the 

NVP in the implementation of Sections 

2102 and 2103 of the PHS Act; and (4) 

identifies annually for the Director of 

the NVP the most important areas of 

governmental and non-governmental 

cooperation that should be considered 

in implementing Sections 2101 and 

2103 of the PHS Act. 

On July 21, 2017, the Acting Assistant 

Secretary for Health approved renewal 

of the NVAC charter with minor 

amendments. The new charter was 

effected and filed with the appropriate 

Congressional committees and Library 

of Congress on July 30, 2017. Renewal 

of the NVAC charter gives authorization 

for the Committee to continue to operate 

until July 30, 2019. 

A copy of the NVAC charter is 

available on the Web site for the 

National Vaccine Program Office at 

http://www.hhs.gov/nvpo/nvac. A copy 

of the charter also can be obtained by 

accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

Web site address for the FACA database 

is http://www.facadatabase.gov/. 

Dated: August 14, 2017. 

Melinda Wharton, 

Acting Director, National Vaccine Program 

Office. 

[FR Doc. 2017–17527 Filed 8–18–17; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Behavioral Health; Office of 

Clinical and Preventive Services; Zero 

Suicide Initiative—Support 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2018–IHS–ZSI–0001. 

Catalog of Federal Domestic 

Assistance Number: 93.933. 

Key Dates 

Application Deadline Date: October 

12, 2017. 

Review Date: October 16–20, 2017. 

Earliest Anticipated Start Date: 

November 1, 2017. 

Signed Tribal Resolution Due Date: 

October 12, 2017. 

Proof of Non-Profit Status Due Date: 

October 12, 2017. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES