Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules 16973 

heading of this document and they may 

be accompanied by a supporting 

memorandum or brief. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 20 be amended as follows: 

PART 20—PUBLIC INFORMATION 

1. The authority citation for 21 CFR 

part 20 continues to read as follows: 

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 

19 U.S.C. 2531–2582; 21 U.S.C. 321–393, 

1401–1403; 42 U.S.C. 241, 242, 242a, 242l, 

242n, 243, 262, 263, 263b–263n, 264, 265, 

300u–300u–5, 300aa–1. 

2. Amend section 20.108 as follows: 

a. Revise paragraph (b); 

b. Remove paragraph (c); 

c. Redesignate paragraph (d) as 

paragraph (c); 

d. Revise newly redesignated 

paragraph (c). 

The revisions and redesignations read 

as follows: 

§ 20.108 Agreements between the Food 

and Drug Administration and other 

departments, Agencies, and organizations. 

* * * * * 

(b) All written agreements and 

memoranda of understanding between 

FDA and any entity, including, but not 

limited to other departments, Agencies, 

and organizations will be made 

available through the Food and Drug 

Administration Web site at http://www.

fda.gov once finalized. 

(c) Agreements and understandings 

signed by officials of the Food and Drug 

Administration with respect to activities 

of the Office of Criminal Investigations 

are exempt from the requirements set 

forth in paragraph (b) of this section. 

Although such agreements and 

understandings will not be made 

available through the Food and Drug 

Administration Web site, these 

agreements will be available for 

disclosure in response to a request from 

the public after deletion of information 

that would disclose confidential 

investigative techniques or procedures, 

or information that would disclose 

guidelines for law enforcement 

investigations if such disclosure could 

reasonably be expected to risk 

circumvention of the law. 

Dated: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6969 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 202 

[Docket No. FDA–2009–N–0582] 

RIN 0910–AG27 

Direct-to-Consumer Prescription Drug 

Advertisements; Presentation of the 

Major Statement in Television and 

Radio Advertisements in a Clear, 

Conspicuous, and Neutral Manner; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of 

comment period on specific data. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening the 

comment period on specific data related 

to a proposed rule published in the 

Federal Register of March 29,, to 

establish standards that would be 

considered in determining whether the 

major statement in direct-to-consumer 

(DTC) television and radio 

advertisements relating to the side 

effects and contraindications of an 

advertised prescription drug intended 

for use by humans is presented in a 

clear, conspicuous, and neutral manner. 

In the Federal Register of January 27, 

2012, FDA announced that it had added 

a document to the docket for the 

proposed rulemaking concerning a 

study entitled ‘‘Experimental Evaluation 

of the Impact of Distraction on 

Consumer Understanding of Risk and 

Benefit Information in Direct-toConsumer Prescription Drug Television 

Advertisements’’ (Distraction Study) 

and the public was given until February 

27, 2012, to comment on this study as 

it relates to the proposed standards. 

FDA is reopening the comment period 

for the rulemaking proceeding in 

response to a request for more time to 

submit comments to the Agency. 

DATES: Submit either electronic or 

written comments on the Distraction 

Study report as it relates to the proposed 

standards by April 9, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2009–N– 

0582 and/or Regulatory Information 

Number (RIN) 0910–AG27, by any of the 

following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (For 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name, docket 

number, and RIN for this rulemaking. 

All comments received may be posted 

without change to http://www.

regulations.gov, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://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 Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT:

For information concerning human 

drug products: Ernest S. Voyard, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3276, 

Silver Spring, MD 20993–0002, 301– 

796–3832. 

For information concerning human 

biological drug products: Stephen 

Ripley, Center for Biologics Evaluation 

and Research (HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 29, 

2010 (75 FR 15376), FDA published a 

proposed rule entitled ‘‘Direct-toConsumer Prescription Drug 

Advertisements; Presentation of the 

Major Statement in Television and 

Radio Advertisements in a Clear, 

Conspicuous, and Neutral Manner,’’ to 

amend its regulations concerning DTC 

advertisements of prescription drugs. 

Specifically, the proposed rule would 

implement a new requirement of the 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
16974 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), added by section 

901(d)(3)(A) of the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) (FDAAA). This 

section requires that the major statement 

in DTC television or radio 

advertisements relating to the side 

effects and contraindications of an 

advertised prescription drug intended 

for use by humans be presented in a 

clear, conspicuous, and neutral manner, 

and directs FDA to publish regulations 

establishing the standards for 

determining whether a major statement 

meets these requirements. As directed 

by section 901(d)(3)(B) of FDAAA, the 

proposed rule described standards that 

the Agency would consider in 

determining whether the major 

statement is clear, conspicuous, and 

neutral, and it provided a 90-day period 

for public comment, which closed on 

June 28, 2010. 

On January 27, 2012 (77 FR 4273), 

FDA reopened the comment period on 

this rulemaking until February 27, 2012, 

to allow an opportunity for interested 

parties to comment on FDA’s analyses 

of the results of its study (see 

attachment in Docket No. FDA–2009– 

N–0582–0040) on the impact of 

distraction on consumer understanding 

of risk and benefit information in DTC 

prescription drug television 

advertisements (72 FR 47051, August 

22, 2007) (Distraction Study) as it relates 

to the proposed standards. The 

Pharmaceutical Research and 

Manufacturers of America (PhRMA) 

submitted a letter dated February 20, 

2012, requesting an additional 15 days 

for interested persons to comment. FDA 

believes that an additional 15 days to 

comment on the Distraction Study as it 

relates to the proposed standards is 

appropriate. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the Distraction 

Study as it relates to the proposed 

standards. 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 and label them ‘‘ATTN: 

Distraction Study.’’ The data and 

received comments may be seen in the 

Division of Dockets Management 

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

through Friday. 

Dated: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6948 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 100 

[Docket No. USCG–2012–0073] 

RIN 1625–AA08 

Special Local Regulations; Ocean 

State Tall Ships Festival 2012, 

Narragansett Bay, RI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish temporary special local 

regulations on the navigable waters of 

Narragansett Bay and Newport Harbor, 

Rhode Island, for the Ocean State Tall 

Ships Festival 2012. This action is 

necessary to provide for the safety of life 

and property on the navigable waters of 

Narragansett Bay and Newport Harbor, 

Rhode Island, during the Ocean State 

Tall Ships Festival on July 6–9, 2012. 

These temporary special local 

regulations would restrict vessel traffic 

in portions of Narragansett Bay and 

Newport Harbor, Rhode Island, unless 

authorized by the Captain of the Port 

(COTP) Sector Southeastern New 

England. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before May 22, 2012. Requests for 

public meetings must be received by the 

Coast Guard on or before April 13, 2012. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2012–0073 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail or Delivery: Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Deliveries 

accepted between 9 a.m. and 5 p.m., 

Monday through Friday, except federal 

holidays. The telephone number is 202– 

366–9329. See the ‘‘Public Participation 

and Request for Comments’’ portion of 

the SUPPLEMENTARY INFORMATION section 

below for further instructions on 

submitting comments. To avoid 

duplication, please use only one of 

these three methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or email Mr. Edward G. 

LeBlanc, Waterways Management 

Division at Coast Guard Sector 

Southeastern New England, telephone 

401–435–2351, email 

Edward.G.LeBlanc@uscg.mil. If you 

have questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted 

without change to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2012–0073), 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online (via http:// 

www.regulations.gov) or by fax, mail, or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online via http:// 

www.regulations.gov, it will be 

considered received by the Coast Guard 

when you successfully transmit the 

comment. If you fax, hand deliver, or 

mail your comment, it will be 

considered as having been received by 

the Coast Guard when it is received at 

the Docket Management Facility. We 

recommend that you include your name 

and a mailing address, an email address, 

or a telephone number in the body of 

your document so that we can contact 

you if we have questions regarding your 

submission. 

To submit your comment online, go to 

http://www.regulations.gov, type the 

docket number (USCG–2012–0073 in 

the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on ‘‘Submit a 

Comment’’ on the line associated with 

this rulemaking. 

If you submit your comments by mail 

or hand delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit 

comments by mail and would like to 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS