Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48083 

events within the protections of the 

Patient Safety Act and Patient Safety 

Rule. As a result, healthcare providers, 

and those committed to improving the 

safety and quality of patient care, have 

a strong interest in the integrity of PSOs 

and their ability to carry out this 

statutory mission. 

AHRQ administers the provisions of 

the Patient Safety Rule relating to listing 

and operation of PSOs, which are the 

focus of this guide. The HHS Office for 

Civil Rights is responsible for enforcing 

the confidentiality protections of the 

Patient Safety Act and Patient Safety 

Rule. 

For an entity to be listed, and remain 

listed, as a PSO, the Patient Safety Rule 

relies primarily upon a system of 

attestations. An entity seeking listing for 

a three-year period as a PSO must 

submit to AHRQ a form, Certification for 

Initial Listing, to attest that it meets the 

Patient Safety Rule’s eligibility and 

listing requirements at the time the 

entity submits its certifications. During 

its period of listing, a PSO must submit 

a form, Two Bona Fide Contract 

Requirement, every two years attesting 

that it has at least two contracts with 

different providers. If the PSO has other 

relationships, specified in section 

3.102(d)(2), with any contracting 

provider, it must also submit the form, 

PSO Disclosure Statement, regarding its 

relationships with the provider and 

attest to the completeness and accuracy 

of its disclosures. Finally, a PSO must 

submit the form, Certification for 

Continued Listing, to seek continued 

listing for an additional three-year 

period and attest that it meets the 

requirements for continued listing. This 

process places the burden for 

understanding and complying with the 

Patient Safety Rule on the PSO. 

The Patient Safety Rule also 

authorizes AHRQ to assess or verify 

PSO compliance with the rule’s 

requirements at any time through 

requests for information or by 

conducting announced or unannounced 

reviews of, or site visits to, PSOs 

(section 3.110). In addition to routine 

compliance reviews, AHRQ may also 

conduct site visits or request additional 

information if, for example, AHRQ 

becomes aware that a PSO is not in 

compliance with the requirements of the 

statute or the Patient Safety Rule. 

The Patient Safety Rule provides 

PSOs latitude in complying with its 

requirements. In part, this reflects a 

recognition that PSOs will vary in terms 

of size, complexity, and sophistication 

and, over time, PSOs will vary 

significantly in the breadth and scope of 

their activities. For example, PSOs can 

be local, regional, or national in 

orientation; they can focus narrowly or 

broadly in terms of the clinical or 

analytic services they offer providers; 

they can target their services toward one 

type of healthcare facility or multiple 

healthcare settings; and, they are likely 

to vary in the sophistication and 

complexity of information technology 

employed. 

Each PSO will need to develop its 

approach to compliance by taking into 

account the specific mission it has 

chosen for itself, the specific activities 

and expertise it offers to healthcare 

providers, and its size and mode of 

operation. As a consequence, AHRQ 

developed this self-assessment guide 

recognizing that individual PSOs are 

likely to approach compliance from 

different perspectives. Thus, the guide 

does not propose a uniform approach to 

compliance, Instead, the guide presents 

sample questions—some of which may 

not be applicable or appropriate to a 

specific PSO—to encourage each PSO to 

take a comprehensive and systematic 

approach to compliance that best meets 

its circumstances. 

The questions in the guide do not 

establish new standards or 

requirements; they are only presented 

for an illustrative purpose. If there is 

any inadvertent discrepancy between 

the text of the guide and the Patient 

Safety Rule, PSOs should consider the 

text of the rule as authoritative. 

More information on the ‘‘Patient 

Safety Organizations: A Compliance Self 

Assessment Guide’’ and PSOs can be 

obtained through AHRQ’s PSO Web site: 

http://www.pso.ahrq.qov/index.html. 

Dated: September 11, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–22594 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0441] 

Promotion of Food and Drug 

Administration-Regulated Medical 

Products Using the Internet and Social 

Media Tools; Notice of Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Drug Evaluation and Research (CDER), 

in collaboration with FDA’s Center for 

Biologics Evaluation and Research 

(CBER), Center for Veterinary Medicine 

(CVM), and Center for Devices and 

Radiological Health (CDRH), is 

announcing a public hearing to discuss 

issues related to the promotion of FDAregulated medical products (including 

prescription drugs for humans and 

animals, prescription biologics, and 

medical devices) using the Internet and 

social media tools. FDA is seeking 

participation in the public hearing and 

written comments from all interested 

parties, including, but not limited to, 

consumers, patients, caregivers, health 

care professionals, patient groups, 

Internet vendors, advertising agencies, 

and the regulated industry. This 

meeting and the written comments are 

intended to help guide FDA in making 

policy decisions on the promotion of 

human and animal prescription drugs 

and biologics and medical devices using 

the Internet and social media tools. FDA 

is seeking input on a number of specific 

questions but is interested in any other 

pertinent information participants in the 

hearing would like to share. 

Dates and Times: The public hearing 

will be held on November 12 and 13, 

2009, from 8 a.m. to 5 p.m. each day. 

Submit written or electronic registration 

by close of business on October 9, 2009. 

Written and electronic comments will 

be accepted until February 28, 2010. 

Location: The public hearing will be 

held at the National Transportation 

Safety Board Conference Center, 429 

L’Enfant Plaza, SW., Washington, DC 

20594, 202–314–6305; Metro: L’Enfant 

Plaza station on the yellow, green, 

orange, and blue lines; see: http:// 

ntsb.gov/events/newlocation.htm. (FDA 

has verified the Web site address, but 

FDA is not responsible for any changes 

to the Web site after this document 

publishes in the Federal Register.) 

ADDRESSES: Submit written registration 

and written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic registration and 

electronic comments, identified with 

the docket number found in brackets in 

the heading of this document, to http:// 

www.regulations.gov. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the hearing 

(see section VI of this document). 

Registration to Attend and/or to 

Participate in the Meeting: Seating at the 

hearing is limited. People interested in 

attending should submit written or 

electronic registration as specified above 

mstockstill on DSKH9S0YB1PROD with NOTICES

48084 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

(see ADDRESSES) by close of business on 

October 9, 2009. Registration is free and 

will be accepted on a first-come, firstserved basis. Written or electronic 

comments will be accepted until 

February 28, 2010. 

The procedures governing the hearing 

are found in 21 CFR part 15 (see section 

IV of this document). If you wish to 

make an oral presentation at the 

hearing, you must state your intention 

on your registration submission (see 

ADDRESSES). To speak, submit your 

name, title, business affiliation, 

addresses, telephone and fax numbers, 

and e-mail address. FDA has included 

questions for comment in section III of 

this document. You should also identify 

by number each question you wish to 

address in your presentation and the 

approximate time requested. FDA will 

do its best to accommodate requests to 

speak. Individuals and organizations 

with common interests should 

consolidate or coordinate their 

presentations and request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. Once FDA notifies registered 

participants of their scheduled times, 

presenters should submit to FDA two 

copies of each presentation to be given 

(see FOR FURTHER INFORMATION CONTACT). 

If you need special accommodations 

because of a disability, please inform 

Jean-Ah Kang (see FOR FURTHER

INFORMATION CONTACT) at the time of 

registration. 

FOR FURTHER INFORMATION CONTACT: 

Jean-Ah Kang, Division of Drug 

Marketing, Advertising, and 

Communications, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3270, 

Silver Spring, MD, 20993–0002, 301– 

796–4269, FAX: 301–796–8444, e-mail: 

InternetPublicMeeting@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Internet has become a widely 

used medium for companies, including 

manufacturers, packers, or distributors 

of medical products regulated by FDA, 

to disseminate information about their 

products. The Internet’s ability to 

facilitate communication, information 

sharing, information exchange between 

systems, user-centered design, and 

collaboration has also evolved as a 

result of the second generation of Web 

development and Web design, or ‘‘Web 

2.0.’’ Web 2.0 has led to the emergence 

of a variety of social media tools (i.e., 

Web properties whose online content is 

primarily created and published by 

users rather than the property owners). 

The continually evolving nature of the 

Internet, including Web 2.0 and social 

media tools, as well as their expansion 

to applications such as mobile 

technology, have raised questions and 

concerns over how to apply existing 

regulations to promotion in these newer 

media. FDA is evaluating how the 

statutory provisions, regulations, and 

policies concerning advertising and 

promotional labeling should be applied 

to product-related information on the 

Internet and newer technologies. 

Although the agency believes that many 

issues can be addressed through existing 

FDA regulations, special characteristics 

of Web 2.0 and other emerging 

technologies may require the agency to 

provide additional guidance to the 

industry on how the regulations should 

be applied. 

A. Regulation of Advertising and 

Labeling 

Under the Federal Food, Drug, and 

Cosmetic Act (the act), FDA has 

responsibility for regulating the labeling 

of prescription drugs and medical 

devices and the advertising of 

prescription drugs and restricted 

medical devices. If an activity or 

material is considered to be either 

advertising or labeling, it must meet 

certain requirements. 

Under section 201(m) of the act (21 

U.S.C. 321(m)), labeling is defined as 

‘‘all labels and other written, printed, or 

graphic’’ materials ‘‘upon’’ or 

‘‘accompanying’’ an article. The term 

‘‘accompanying’’ has been broadly 

defined by the Supreme Court (Kordel v. 

United States, 335 U.S. 345, 349–350 

(1948)). FDA’s regulations give 

examples of labeling materials, 

including brochures, mailing pieces, 

detailing pieces, calendars, price lists, 

letters, motion picture films, and sound 

recordings (§ 202.1(l)(2) (21 CFR 

202.1(l)(2))). 

FDA regulates the labeling of all drugs 

and devices under its jurisdiction. 

Labeling must be truthful and 

nonmisleading (section 502(a) of the act 

(21 U.S.C. 352(a))). 

FDA also regulates the advertising for 

prescription drugs and biologics. 

Although the act does not define what 

constitutes an ‘‘advertisement,’’ FDA 

generally interprets the term to include 

information (other than labeling) that is 

issued by, or on behalf of, a 

manufacturer, packer, or distributor and 

is intended to promote a product. This 

includes, for example, ‘‘advertisements 

in published journals, magazines, other 

periodicals, and newspapers, and 

advertisements broadcast through media 

such as radio, television, and telephone 

communication systems’’ (§ 202.1(l)(1)). 

According to the act (section 502(n)), a 

prescription drug is misbranded if its 

advertising does not include, in 

addition to the product’s established 

name and quantitative composition, a 

‘‘true statement’’ of information in brief 

summary ‘‘relating to side effects, 

contraindications and effectiveness’’ of 

the advertised product. For prescription 

drug advertisements, FDA’s 

implementing regulations (21 CFR part 

202) specify that, among other things, 

the statutory requirement of a ‘‘true 

statement’’ is not satisfied if an 

advertisement is false or misleading 

with respect to side effects, 

contraindications or effectiveness or if it 

fails to reveal material facts about 

‘‘consequences that may result from the 

use of the drug as recommended or 

suggested in the advertisement’’ 

(§ 202.1(e)(5)). The prescription drug 

regulations also specify that 

advertisements must ‘‘present a fair 

balance between information relating to 

side effects and contraindications and 

information relating to effectiveness of 

the drug,’’ which is achieved when ‘‘the 

presentation of true information relating 

to side effects and contraindications is 

comparable in depth and detail with the 

claims for effectiveness or safety’’ 

(§ 202.1(e)(5)(ii)). 

FDA similarly regulates advertising 

for restricted devices. A ‘‘restricted 

device’’ is a device that may be 

restricted to sale, distribution, or use 

only with the written or oral 

authorization of a licensed practitioner, 

or in accordance with other conditions 

if FDA determines that there cannot 

otherwise be reasonable assurance of its 

safety and effectiveness (21 U.S.C. 

360j(e)). FDA also restricts devices 

through the approval orders granted to 

many class III devices (21 U.S.C. 

360e(d)(1)(B)(ii)). According to the act, a 

restricted device is misbranded if its 

advertising is false or misleading in any 

particular (section 502(q) of the act), or 

if its advertising does not contain a brief 

statement of the intended uses of the 

device and relevant warnings, 

precautions, side effects, and 

contraindications (section 502(r) of the 

act). There are currently no regulations 

establishing specific requirements for 

the content and format of 

advertisements for restricted devices. 

Although FDA has not 

comprehensively addressed when 

Internet promotion of prescription drugs 

and medical devices is labeling versus 

advertising, the agency has jurisdiction 

over all prescription drug and biologic 

product promotion as well as all 

restricted device advertising and all 

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Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48085 

1Adapted from http://newmedia.hhs.gov/ 

socialmedia101.html Social Media 101 Overview: 

The WHAT and the WHY. Accessed on August 14, 

2009. 

2Adapted from http://www.usa.gov/webcontent/ 

technology/other_tech.shtml Social Media and Web 

2.0 in Government. Accessed on August 14, 2009. 

device promotional labeling when 

conducted by or on behalf of a 

manufacturer, packer, or distributor. 

There are no regulations that 

specifically address Internet promotion 

separately from the other types of 

promotion discussed above, nor are 

there any regulations that prohibit the 

use of certain types of media to promote 

drugs and medical devices. Although no 

rule has specifically addressed Internet 

promotion, it is fairly clear that some 

promotional efforts are substantially 

similar in presentation and content to 

promotional materials in other media or 

publications. At the same time, FDA 

recognizes that the Internet possesses 

certain unique technological features 

and that some online tools that may be 

used for promotion offer novel 

presentation and content features. 

Another emerging issue involves the 

reporting of adverse event data because 

such information may initially be 

revealed using social media platforms in 

the context of Internet promotion for 

FDA-regulated medical products. 

B. 1996 Meeting on Promotion of FDARegulated Products on the Internet 

On October 16 and 17, 1996, FDA 

held a public meeting to discuss issues 

related to the promotion of FDAregulated medical products on the 

Internet (see 61 FR 48707, September 

16, 1996). The agency’s objective was to 

receive broad public input and to hear 

various points of view and opinions on 

Internet issues from a discussion among 

interested persons. A discussion group 

format was used and covered the 

following topics: Investigational product 

information, chatrooms and 

newsgroups, and Web site links. A 

transcript of the meeting is available at 

http://www.fda.gov/AboutFDA/ 

CentersOffices/CDER/ucm175775.htm.) 

C. New Internet Tools and Technology 

Since the 1996 public meeting, there 

has been a massive expansion of new 

tools and technologies, such as blogs, 

microblogs, podcasts, social network 

sites (‘‘social networks’’) and online 

communities, video sharing, widgets, 

and wikis, which are defined as 

follows:1,2

• Blogs (e.g., Blogger, WordPress, 

TypePad): Blogs are Web sites with 

regular updates (in reverse 

chronological order—newest update at 

the top) that typically combine text, 

images (graphics or video), and links to 

other Web pages. Blogs are usually 

informal and take on the tone of a diary 

or journal entry. Some blogs are very 

personal, while others provide 

mainstream news updates. Most blogs 

encourage dialogue by allowing their 

readers to leave comments. 

• Microblogs (e.g., Twitter): 

Microblogs are comprised of extremely 

short written blog posts, similar to text 

messages, and provide real-time 

updates. Twitter is an example of a 

popular microblog service that lets users 

broadcast short messages up to 140 

characters long (‘‘tweets’’) using 

computers or mobile phones. 

• Podcasts (e.g., audio sharing): 

Podcasts (a blend of the terms ‘‘iPod’’ 

and ‘‘broadcast’’) are audio or video files 

that users can listen to or watch on 

computers or on a variety of portable 

media devices (like an iPod, Zune, and 

certain cell phones). Podcasts are 

usually short and often free, and users 

can arrange via subscription to receive 

new podcasts automatically via their 

computers or other media devices. 

• Social networks and online 

communities (e.g., Facebook, MySpace, 

LinkedIn, Friendster, Sermo): Social 

networks and online communities give 

users opportunities to connect with or 

provide resources to clients, colleagues, 

family, and friends who share common 

interests. In many social networks, users 

create profiles and then invite people to 

join as ‘‘friends.’’ There are many 

different types of social networks and 

online communities, many of which are 

free, and they range from general to 

those tailored for a specific 

demographic or interest area. 

• Video sharing (e.g., YouTube, 

Blip.tv, Vimeo): Also called a ‘‘video 

hosting service,’’ video sharing allows 

individuals to upload video clips to an 

Internet Web site. The video host will 

then store the video on its server and 

show the individual different types of 

code to allow others to view or 

comment on the video. 

• Widgets: Supposedly short for 

‘‘window gadget,’’ a widget is a graphic 

control on a Web page that allows the 

user to interact with it in some way. 

Widgets can also be easily posted on 

multiple Web sites, have the added 

benefit of hosting ‘‘live’’ content, and 

often take the form of on-screen tools 

(clocks, event countdowns, auctiontickers, stock market tickers, flight 

arrival information, daily weather, etc.). 

• Wikis (e.g., Wikipedia, Medpedia): 

The term ‘‘wiki’’ comes from the 

Hawaiian word for ‘‘fast.’’ Wiki 

technology creates a Web page that 

anyone with access can modify— 

quickly and easily. A wiki can be either 

open or closed, depending on the 

preferences of the community using it. 

An open wiki allows anybody to make 

changes and view content. A closed 

wiki allows only community members 

to make changes and view its content. 

Some wikis allow anyone to view 

content but only members to edit the 

content. 

As the use of social media tools on the 

Internet has proliferated, the agency has 

engaged in a fact-finding process by 

communicating with companies, thirdparty providers, trade associations, and 

other groups to gain a better 

understanding of the nature of, and the 

technical aspects to, promotion of FDAregulated medical products using these 

tools. FDA appreciates the time and 

effort that these individuals, companies, 

and associations have invested in 

assisting the agency in understanding 

the challenges and issues involved with 

Internet promotion using these newer 

Web 2.0 technologies. 

II. Purpose and Scope of the Hearing 

This hearing is intended to provide an 

opportunity for broad public 

participation and comment concerning 

Internet promotion of FDA-regulated 

medical products, including human and 

animal prescription drugs and biologics 

and medical devices. Please note that 

this hearing does not address 

nonprescription drug promotion. FDA is 

particularly interested in hearing views 

from the public as to how expanding 

Web 2.0 technologies may be used to 

promote medical products to both 

health care professionals and consumers 

in a truthful, nonmisleading, and 

balanced manner. In addition, FDA is 

seeking public comment on Internet 

adverse event reporting. 

III. Issues for Discussion 

Questions have arisen regarding the 

application of the prescription drug and 

device advertising and labeling 

provisions, regulations, and policies of 

promotion on the Internet, especially 

with regard to the use of emerging 

technologies such as blogs, microblogs, 

podcasts, social networks and online 

communities, video sharing, widgets, 

and wikis. This section briefly discusses 

the issues the agency has identified as 

most frequently raised by regulated 

companies and other interested parties. 

It should be noted that although a 

question may raise a particular issue, 

that does not necessarily mean that the 

agency will issue guidance or a 

regulation on that issue. 

The agency invites comment at the 

public hearing on the general concept of 

Internet promotion, positive or negative; 

on any aspect of Internet promotion that 

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48086 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

is of interest to the presenter; and on the 

topics outlined in the following 

paragraphs. We are specifically 

interested in data and research on the 

use of social media tools in promotion, 

including data from companies on their 

own experiences, the extent to which 

health care professionals and consumers 

are using and are influenced by various 

social media tools, and the impact of 

Internet and social media promotion on 

the public health. 

1. For what online communications are 

manufacturers, packers, or distributors 

accountable? 

FDA regulates promotion of medical 

products that is conducted by or on 

behalf of a manufacturer, packer, or 

distributor. In determining whether a 

manufacturer, packer, or distributor is 

accountable for a communication about 

its product(s), the agency considers 

whether the manufacturer, packer, or 

distributor or anyone acting on behalf of 

the manufacturer, packer, or distributor, 

such as an ad agency, created the 

promotional communication. In 

addition, the agency considers whether 

the manufacturer, packer, or distributor 

or anyone acting on behalf of the 

manufacturer, packer, or distributor is 

influencing or controlling the 

promotional activity or communication 

in whole or in part. 

Manufacturers, packers, and 

distributors may have a variety of 

options for how much control they exert 

over activities on the Internet, regardless 

of whether the promotional activity 

occurs on company-sponsored venues 

or on third-party venues. For example, 

in setting up a program about its 

product(s) through a chatroom, a 

manufacturer, packer, or distributor may 

allow comments to be posted in real 

time with no editing or review by the 

manufacturer, packer, or distributor; 

alternatively, the manufacturer, packer, 

or distributor may have the option of 

reviewing and editing comments before 

they are posted. Furthermore, the 

manufacturer, packer, or distributor may 

have control over the length of time 

comments are visible. As a result, 

information may be available to a much 

broader audience than originally 

engaged in the communication or 

program if the comments/entries are 

posted for an indefinite period of time 

(‘‘archived materials’’). Similarly, a 

manufacturer, packer, or distributor 

posting a video on a video-sharing site 

such as YouTube may choose whether 

or not to allow viewers to post 

comments. 

In addition, various Web sites and 

tools can allow manufacturers, packers, 

or distributors to prompt others to 

communicate about their products. For 

example, a manufacturer, packer, or 

distributor may ask or otherwise 

encourage users to post their own 

videos about its product(s) on sites such 

as YouTube. A manufacturer, packer, or 

distributor may also send out packets of 

information to prominent bloggers with 

the aim of prompting the blogger to 

write about its product(s). Alternatively, 

a manufacturer, packer, or distributor 

may create an online community for 

patients or health care professionals to 

discuss disease states, which may 

prompt discussion about the 

manufacturer’s, distributor’s, or packer’s 

product(s). The agency is interested in 

hearing the views of the public on the 

following topics: 

• What parameters or criteria should 

be applied to determine when thirdparty communications occurring on the 

Internet and through social media 

technologies are subject to substantive 

influence by companies that market 

products related to the communication 

or discussion? 

• In particular, when should thirdparty discussions be treated as being 

performed by, or on behalf of, the 

companies that market the product, as 

opposed to being performed 

independent of the influence of the 

companies marketing the products? 

• How should companies disclose 

their involvement or influence over 

discussions or material, particularly 

discussions or material on third-party 

sites? 

• Are there different considerations 

that should be weighed depending on 

the specific social media platform that 

is used or based on the intended 

audience? If so, what are these 

considerations? 

• With regard to the potential for 

company communications to be altered 

by third parties, what is the experience 

to date with respect to the unauthorized 

dissemination of modified product 

information (originally created by a 

company) by noncompany users of the 

Internet? 

2. How can manufacturers, packers, or 

distributors fulfill regulatory 

requirements (e.g., fair balance, 

disclosure of indication and risk 

information, postmarketing submission 

requirements) in their Internet and 

social media promotion, particularly 

when using tools that are associated 

with space limitations and tools that 

allow for real-time communications 

(e.g., microblogs, mobile technology)? 

FDA’s regulations require that any 

promotional communications that make 

claims about a company’s product 

include certain required disclosures, 

such as the indicated use of the product 

and the risks associated with the use of 

the product (note that ‘‘reminder’’ 

promotion, which calls attention to the 

name of a product but does not make 

any representations or suggestions about 

the product, is exempt from these 

disclosure requirements (see 21 CFR 

200.200, 201.100(f), 201.105(d)(2), 

202.1(e)(2)(i), 801.109(d)). The 

prescription drug regulations also 

require that drug advertisements present 

a fair balance between information 

relating to risk and information relating 

to benefit (§ 202.1(e)(5)(ii)). They also 

specify that risk information must be 

presented with a prominence and 

readability reasonably comparable to 

claims about drug benefits 

(§ 202.1(e)(7)(viii)). Furthermore, for 

advertisements to be truthful and 

nonmisleading, they must contain risk 

information in each part as necessary to 

qualify any representations and/or 

suggestions made in that part about the 

drug (§ 202.1(e)(3)(i)). Similarly, section 

502(r) of the act requires a ‘‘brief 

statement’’ of intended use and relevant 

risk information for restricted device 

advertising. In addition, section 201(n) 

of the act provides that a determination 

of whether product advertising or 

labeling is misleading relies in part on 

the extent to which labeling or 

advertising reveals facts material with 

respect to possible consequences of the 

use of the products as represented in the 

labeling or advertising material. Except 

for medical device applicants, 

applicants are also responsible for 

submitting copies of promotional 

materials to FDA (see, e.g., 

§§ 314.81(b)(3)(i), 314.550, 314.640, 

514.80(b)(5)(ii), 601.12(f)(4), 601.45, and 

601.94 (21 CFR 314.81(b)(3)(i), 314.550, 

314.640, 514.80(b)(5)(ii), 601.12(f)(4), 

601.45, and 601.94)). 

• How should product information be 

presented using various social media 

tools to ensure that the user has access 

to a balanced presentation of both risks 

and benefits of medical products? 

• Are there data to support 

conclusions about whether different 

types or formats of presentations have a 

positive or negative impact on the 

public health? 

• Are there proposed solutions that 

may help address regulatory concerns 

when using social media tools 

associated with space limitations or 

tools that allow for real-time 

communications to present product 

information? 

• How should companies address the 

potential volume of information shared 

on various social media sites with 

regard to real-time information that is 

continuously posted and regulatory 

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Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48087 

requirements to submit promotional 

materials to FDA as applicable (see, e.g., 

§§ 314.81(b)(3)(i), 314.550, 314.640, 

514.80(b)(5)(ii), 601.12(f)(4), 601.45, and 

601.94)? 

3. What parameters should apply to the 

posting of corrective information on 

Web sites controlled by third parties? 

Some manufacturers, packers, or 

distributors have expressed a desire to 

correct what are, in their belief, 

misconceptions or misinformation about 

their products, including unapproved 

uses of their products that are being 

conveyed on a Web site outside their 

control, such as on a blog, social 

networking site, or a wiki Web site (i.e., 

Wikipedia). Other companies have 

stated that they have not corrected what 

they believe is misinformation in the 

belief that they could be viewed by such 

an action as being responsible for all the 

information on the target Web site rather 

than just the information that they post 

or submit. 

• The agency is interested in any data 

or research on how companies have 

approached these issues. 

• Are there any parameters or criteria 

that could be used to determine the 

appropriateness of correcting 

misinformation and/or scope of 

information a company can provide 

when trying to correct misinformation 

on a Web site outside a company’s 

control? 

• Should the parameters differentiate 

with regard to the prominence of the 

third-party site (i.e., readership), its 

intended audience (e.g., general public, 

health care professionals, patients), its 

intended purpose (e.g., personal diary, 

encyclopedia-type reference), and/or the 

author of the information on the site? 

4. When is the use of links appropriate? 

The Internet allows users to move 

easily between Web sites or sources that 

provide information on many related 

topics. Under the act, companies are 

prohibited from promoting approved 

human and animal drugs, biologics, and 

medical devices for unapproved uses. 

However, sponsors sometimes provide 

links from their branded (e.g., mentions 

a product) Web sites to other 

informational sources about diseases, 

such as support groups, some of which 

may contain information about 

unapproved disease conditions or 

unapproved uses of approved products. 

Furthermore, some companies are using 

unbranded (e.g., does not mention a 

product) uniform resource locators 

(URLs) that, when clicked on, take users 

directly to branded information. 

• The agency is interested in any 

comments about the appropriateness of 

various techniques regarding the use of 

links (including between various social 

media tools) and data or research about 

whether or not users find these 

approaches to be misleading. 

• Should parameters be established 

for links to and from Web sites? 

• In addition, the agency is interested 

in any data or research concerning the 

frequency with which users actually 

click on different categories of links 

(e.g., banner ads, links within Web sites, 

sponsored links, organic search result 

links) to get additional information 

about products. 

5. Questions specific to Internet adverse 

event reporting 

FDA regulations require the 

submission of postmarketing adverse 

event reports. 

For drugs, adverse event reporting 

obligations are described for approved 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), and prescription drugs 

marketed without an approved 

application under §§ 310.305, 314.80, 

and 314.98 (21 CFR 310.305, 314.80, 

and 314.98, respectively. For new 

animal drugs, adverse event reporting 

obligations are described for approved 

new animal drug applications (NADAs) 

and abbreviated new animal drug 

applications (ANADAs) under § 514.80. 

Licensed manufacturers that hold 

biological license applications (BLAs) 

are also subject to adverse event 

reporting requirements under § 600.80 

(21 CFR 600.80). These regulations 

cover requirements for submission of 

individual case safety reports on either 

an expedited basis (i.e., 15-day ‘‘Alert 

reports’’) or on a less frequent (periodic) 

basis, as specified in the regulations. 

Nonprescription (over-the-counter or 

OTC) drugs marketed without an 

approved application also have 

reporting obligations under the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act (Public Law 

109–462). Under this act, reports of 

serious adverse events associated with 

OTC products must be submitted to 

FDA within 15 days. 

FDA’s Medical Device Reporting 

(MDR) regulation, 21 CFR part 803, 

requires medical device manufacturers 

to identify and monitor significant 

adverse events involving their medical 

devices. The regulation requires 

manufacturers of medical devices to 

report device-related deaths, serious 

injuries, and malfunctions to FDA 

whenever they become aware of 

information that reasonably suggests 

that a reportable event occurred (i.e., 

one of their devices has or may have 

caused or contributed to the event). 

The expectation is that entities 

responsible for reporting will promptly 

review all adverse event information 

received or otherwise obtained, which 

potentially includes information from 

the Internet and social media tools. 

According to FDA’s March 2001 draft 

guidance for industry entitled 

‘‘Postmarketing Safety Reporting for 

Human Drug and Biological Products 

Including Vaccines’’ (available at http:// 

www.fda.gov/downloads/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

Vaccines/ucm092257.pdf), adverse 

experience information that is 

submitted via the Internet to an entity 

with postmarketing reporting 

obligations under §§ 310.305, 314.80, 

and 600.80 should be reported to FDA 

if there is knowledge of the four basic 

elements for submission of an 

individual case safety report (see section 

IV.B in the draft guidance). The draft 

guidance also states that those entities 

should review any Internet sites 

sponsored by them for adverse 

experience information, but are not 

responsible for reviewing any Internet 

sites that they do not sponsor; however, 

if they become aware of an adverse 

experience on an Internet site that they 

do not sponsor, they should review the 

adverse experience and determine if it 

should be reported to FDA. For OTC 

products, the July 2009 guidance for 

industry entitled ‘‘Postmarketing 

Adverse Event Reporting for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application’’ (available at http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ucm171672.pdf) 

lists the Internet as an example of a 

means for a reporter to convey adverse 

event information associated with an 

OTC product to the responsible person 

(i.e., ‘‘manufacturer, packer, or 

distributor whose name * * * appears 

on the label of an OTC drug marketed 

in the United States without an 

approved application’’). 

With the increasing use of Web-based 

technology by manufacturers of FDAregulated medical products, health care 

systems, and patients, and the continual 

emergence of different types of Webbased media, FDA is interested in 

hearing the views of the public on the 

following topics related to Web-based 

media: 

• How are entities with 

postmarketing reporting responsibilities 

and other stakeholders using the 

Internet and social media tools with 

regard to monitoring adverse event 

information about their products? 

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48088 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

• How is adverse event information 

from these sources being received, 

reviewed, and processed? 

• What challenges are presented in 

handling adverse event information 

from these sources? 

• What uncertainties are there 

regarding what should be reported from 

these sources to meet FDA adverse 

event reporting obligations? 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The hearing will be conducted by 

a presiding officer, accompanied by 

FDA senior management from the Office 

of the Commissioner and the Center for 

Drug Evaluation and Research. 

Under § 15.30, the hearing is informal, 

and the rules of evidence do not apply. 

No participant may interrupt the 

presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10 (21 CFR part 10), 

subpart C). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). To the extent that the 

conditions for the hearing, as described 

in this document, conflict with any 

provisions set out in part 15, this 

document acts as a waiver of those 

provisions as specified in § 15.30(h). 

V. Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

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. 

VI. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: September 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22618 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Request for Information Regarding 

Development and Operation of a 

Transplantation Sentinel Network 

AGENCY: Office of Blood, Organ and 

Other Tissue Safety, Division of 

Healthcare Quality Promotion, Center 

for Preparedness, Detection, and Control 

of Infectious Diseases, Centers for 

Disease Control and Prevention, 

Department of Health and Human 

Services. 

ACTION: Request for information notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) is seeking 

information on development and 

operation of a national transplantation 

sentinel network (TSN) for the United 

States, including resources needed for 

management of such a system. The 

purpose of the network is to detect and 

prevent disease transmission from organ 

and tissue allografts recovered for 

transplantation. 

In June 2005, the CDC announced a 

Request for Application (RFA) through 

a cooperative agreement for 

development of a TSN for organizations 

that recover, process, distribute, and 

implant organs and tissues. The overall 

goal of the system was to improve 

patient safety for organ and tissue 

recipients. The RFA objectives were to: 

(1) Identify and track organs and tissues 

to facilitate intervention following 

recognition of infections among 

recipients or donors; (2) improve 

communication among those in the 

transplant community, healthcare 

facilities and public health agencies 

concerning potential risks for 

transmission of infections; and (3) 

improve pathologic and microbiologic 

capabilities on cadaveric donor 

specimen samples through shared 

resources. Development and field 

testing of the prototype was completed 

in 2008. 

For this RFI, respondents are asked to 

describe experiences, plans or opinions 

regarding aspects of completing and 

operating a TSN system; system 

governance, security, and marketing; 

user training; and operational and 

infrastructure management. Responses 

need not address every aspect of this 

RFI; responses may be limited to 

address specific components or portions 

of a section. The specific sections 

requested for comments are: (1) 

Transition of Transplantation 

Transmission Sentinel Network (TTSN) 

Prototype to Full Production; (2) 

Standardization and Compatibility 

Issues; (3) Reporting Criteria; (4) 

Interoperability and Interfacing with 

Existing Data Sources; (5) System 

Operation and Infrastructure 

Management; (6) Analysis Plan 

including Feedback to Users; (7) Patient 

Health Information Privacy and 

Security; and (8) System Governance. 

DATES: Comments must be submitted on 

or before December 11, 2009. 

ADDRESSES: The entire TSN RFI can be 

accessed at http://wwwdev.cdc.gov/ 

ncidod/dhqp/pdf/ttsn/RFI_TSN_

FedRegDoc_9909.pdf. Electronic 

responses are preferred and should be 

sent to TransplantRFI@cdc.gov. 

Responses sent in hard copy format 

must be securely bound and sent to 

Debbie Seem, Office of Blood, Organ 

and other Tissue Safety, Division of 

Healthcare Quality Promotion, Centers 

for Disease Control and Prevention, 

Building 16, MS–A07, 1600 Clifton 

Road, NE., Atlanta, GA, 30329–4018, 

Telephone number: 404–639–3234, Email Address: gqi4@cdc.gov. 

SUPPLEMENTARY INFORMATION: Each year 

in the United States, more than 28,000 

solid organs and 2 million tissues are 

transplanted, including heart, lung, 

liver, kidneys, pancreas, intestine, bone, 

skin, heart valves, tendons, fascia and 

corneas. Donor-derived infections have 

been identified as a source of morbidity 

and mortality among both solid organ 

and tissue transplant recipients. 

Infectious transmission identified in 

the past few years among solid organs 

have reflected a broad array of viruses, 

bacteria, and parasites, resulting in a 

high proportion of mortality amongst 

infected recipients; examples include 

HIV, hepatitis C virus (HCV), 

lymphocytic choriomeningitis virus, 

Mycobacterium tuberculosis, 

Pseudomonas aeruginosa, Strongyloides 

spp, and Trypanosoma cruzi, the 

etiologic agent of Chagas Disease. 

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