
[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16971-16973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6969]



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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.

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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 Sec.  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 Sec.  20.108 was to promote 
transparency by providing access to these stakeholders.
    This proposed rule would eliminate the requirement in current Sec.  
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 
Sec.  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 Sec.  
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 Sec.  20.108, the 
accessibility of records of widespread interest to consumers, industry, 
professional groups, associations, educators, and other government 
Agencies.
    Currently, Sec.  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

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(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 Sec.  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 Sec.  20.108(d), which would be 
revised and redesignated as Sec.  20.108(c).
    This proposed rule would not amend Sec.  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-and-comment 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

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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:


Sec.  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


