Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules 16971 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 20 

[Docket No. FDA–2012–N–0205] 

Agreements and Memoranda of 

Understanding Between the Food and 

Drug Administration and Other 

Departments, Agencies, and 

Organizations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: We are publishing this 

companion proposed rule to the direct 

final rule on ‘‘Agreements and 

Memoranda of Understanding Between 

the Food and Drug Administration and 

Other Departments, Agencies, and 

Organizations,’’ which makes technical 

changes intended to update a 

requirement that many of these 

agreements and memoranda of 

understanding (MOUs) be published in 

the Federal Register. Because we 

already post and will continue to post 

our ongoing agreements and MOUs with 

other departments, Agencies, and 

organizations on our Web site upon 

their completion, this requirement is no 

longer necessary. This proposed rule, 

accordingly, would eliminate it. We are 

proposing these technical changes to 

conserve Agency time and resources, 

reduce government paperwork, and 

eliminate unnecessary Federal Register 

printing costs while continuing to afford 

public access to these documents. 

DATES: Submit either electronic or 

written comments on or before June 6, 

2012. If we receive any significant 

adverse comments, we will publish a 

document withdrawing the direct final 

rule within 30 days after the comment 

period ends. We will then proceed to 

respond to comments under this 

proposed rule using the usual notice 

and comment procedures. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0205 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• 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 and 

Docket No. FDA–2012–N–0205 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: 

Daniel W. Sigelman, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4706, FAX: 301–847–8616, 

email: daniel.sigelman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 3, 

1974 (39 FR 35697), we announced that 

copies of all our MOUs transacted with 

government Agencies and 

nongovernment organizations were 

available for public review at our offices 

during working hours and would be 

published in the Federal Register. We 

subsequently codified this policy in the 

Federal Register of December 24, 1974 

(39 FR 44602 at 44651), and recodified 

it where it currently appears in § 20.108 

(21 CFR 20.108) in the Federal Register 

of March 22, 1977 (42 FR 15616 at 

15625). 

Consumers, industry, professional 

groups, associations, educators, and 

other government Agencies had 

manifested widespread interest in the 

texts of these MOUs. The intent of 

§ 20.108 was to promote transparency 

by providing access to these 

stakeholders. 

This proposed rule would eliminate 

the requirement in current § 20.108(c) 

that our agreements and MOUs with 

other departments, Agencies, and 

organizations be published in the 

Federal Register on an individual basis 

and instead will require that they be 

posted on our Web site. We increasingly 

rely on Internet-based communications 

to ensure and promote transparency in 

our operations and activities. So it is 

with this proposed rule, which would 

merely recognize and codify our already 

established practice of making our 

ongoing agreements and MOUs with 

other departments, Agencies, and 

organizations publicly available on our 

Web site. At the time of this writing, 

each such publicly disclosable 

agreement and MOU can be accessed at 

one of the following three Food and 

Drug Administration (FDA) Web site 

locations: 

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

PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

DomesticMOUs/default.htm; 

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

PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

AcademiaMOUs/default.htm; or 

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

PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

OtherMOUs/default.htm. 

Because all publicly disclosable 

agreements and MOUs are posted on our 

Web site, it is no longer necessary to 

require, as does current § 20.108(b), that 

a permanent file of them be available for 

public review during working hours in 

the Agency’s Freedom of Information 

Public Room. Accordingly, the proposed 

rule would revise current § 20.108(b). 

The public’s access to an FDA Web 

site that is regularly updated to include 

agreements and MOUs as they are 

completed has already greatly enhanced 

the speed, ease, and convenience with 

which stakeholders can obtain and 

review these documents. 

Our proposed technical changes 

would lessen demands on the time of 

our staff and reduce the Government 

paperwork and printing costs associated 

with Federal Register publication of 

newly completed agreements and MOUs 

with other departments, Agencies, and 

organizations. At the same time, it 

would continue to ensure, consistent 

with the underlying intent of § 20.108, 

the accessibility of records of 

widespread interest to consumers, 

industry, professional groups, 

associations, educators, and other 

government Agencies. 

Currently, § 20.108(c) treats our 

cooperative work-sharing agreements 

with State or local government Agencies 

differently from our agreements and 

MOUs with other Agencies and 

organizations. Because these 

cooperative work-sharing agreements 

rarely vary significantly from one 

another, we decided against publishing 

their full texts in the Federal Register 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
16972 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Proposed Rules 

(51 FR 19851, June 3, 1986). Instead, 

since 1993, we have merely required 

them to be listed at least once every 2 

years in the Federal Register (58 FR 

48794, September 20, 1993). This 

proposed rule would end such disparate 

treatment. Proposed § 20.108(b) would 

apply to all of our written agreements 

and MOUs with other departments, 

Agencies, and organizations, including 

cooperative work-sharing agreements 

with State or local government 

Agencies, except for signed agreements 

and MOUs relating to activities of our 

Office of Criminal Investigations, which 

are addressed in § 20.108(d), which 

would be revised and redesignated as 

§ 20.108(c). 

This proposed rule would not amend 

§ 20.108(a) (stating that our written 

agreements and MOUs are available for 

public disclosure). 

II. Companion Document to Direct 

Final Rulemaking 

This proposed rule is a companion to 

the direct final rule published elsewhere 

in this issue of the Federal Register. The 

direct final rule and this companion 

proposed rule are substantively 

identical. This companion proposed 

rule provides the procedural framework 

within which the rule may be finalized 

in the event that any significant adverse 

comment is received in response to the 

direct final rule and it is withdrawn. 

FDA is publishing the direct final rule 

because we believe the rule is 

noncontroversial, and we do not 

anticipate receiving any significant 

adverse comments. If no significant 

adverse comment is received in 

response to the direct final rule, no 

further action will be taken related to 

this proposed rule. Instead we will 

publish a document confirming the 

effective date within 30 days after the 

comment period ends, confirming when 

the direct final rule will go into effect. 

If we receive any significant adverse 

comment regarding the direct final rule, 

we will withdraw the direct final rule 

within 30 days after the comment 

period ends and proceed to respond to 

all of the comments under this 

companion proposed rule using usual 

notice-and-comment rulemaking 

procedures under the Administrative 

Procedures Act (APA) (5 U.S.C. 552a et 

seq.). The comment period for this 

companion proposed rule runs 

concurrently with the comment period 

for the direct final rule. Any comments 

received under this companion 

proposed rule will also be considered as 

comments regarding the direct final 

rule, and vice versa. We will not 

provide additional opportunity for 

comment. A significant adverse 

comment is defined as a comment that 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. In 

determining whether an adverse 

comment is significant and warrants 

withdrawing a direct final rule, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-andcomment process in accordance with 

section 553 of the APA (5 U.S.C. 553). 

Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered adverse 

under this procedure. For example, a 

comment recommending an additional 

change to the rule will not be 

considered a significant comment 

unless the comment states why the rule 

would be ineffective without the 

additional change. In addition, if a 

significant adverse comment applies to 

part of a rule and that part can be 

severed from the remainder of the rule, 

we may adopt as final those parts of the 

rule that are not the subject of a 

significant adverse comment. 

In the Federal Register of November 

21, 1997 (62 FR 62466), we announced 

the availability of the guidance 

document entitled ‘‘Guidance for FDA 

and Industry: Direct Final Rule 

Procedures.’’ This guidance document 

may be accessed at http://www.fda.gov/ 

RegulatoryInformation/Guidances/

ucm125166.htm. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct Agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The Agency 

believes that this proposed rule is not a 

significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the proposed rule 

would not impose any significant costs, 

we propose to certify that the final rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. We do not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

IV. Paperwork Reduction Act of 1995 

We have concluded that this proposed 

rule contains no ‘‘collections of 

information. ’’ Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501–3520) is not 

required. 

V. Environmental Impact 

We have determined under 21 CFR 

25.33 that this proposed rule is of a type 

that would not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, we tentatively conclude 

that the proposed rule does not contain 

policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

VII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
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