
[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Rules and Regulations]
[Pages 16923-16925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6967]


=======================================================================
-----------------------------------------------------------------------

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: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: This direct final rule makes technical changes that will 
update a requirement that many of our written agreements and memoranda 
of understanding (MOUs) with other departments, Agencies, and 
organizations 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 direct 
final rule, accordingly, eliminates it. We are making 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. We are 
proceeding in accordance with our direct final rule procedures.
    We are publishing a companion proposed rule under our usual 
procedure for notice-and-comment rulemaking to provide a procedural 
framework to finalize the rule in the event we receive any significant 
adverse comments and withdraw this direct final rule. The companion 
proposed rule and this direct final rule are substantively identical.

DATES: This rule is effective August 6, 2012. Submit either electronic 
or written comments on or before June 6, 2012. If we receive no 
significant adverse comments within the specified comment period, we 
will publish a document confirming the effective date of the final rule 
in the Federal Register within 30 days after the comment period on this 
direct final rule ends. If timely significant adverse comments are 
received, the Agency will publish a document in the Federal Register 
withdrawing this direct final rule before its effective date.

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

[[Page 16924]]

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 at 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 direct final rule will 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 as completed. We increasingly rely on Internet-based 
communications to ensure and promote transparency in our operations and 
activities. So it is with this direct final rule, which merely 
recognizes and codifies 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, this rule will 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.
    The rule's technical changes will 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 will 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 (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 48793, September 20, 1993). This direct 
final rule will end such disparate treatment. Revised Sec.  20.108(b) 
will 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 
will be revised and redesignated as Sec.  20.108(c).
    This direct rule does not amend Sec.  20.108(a) (stating that our 
written agreements and MOUs are available for public disclosure).

II. Direct Final Rulemaking

    We have determined that the subject of this rulemaking is suitable 
and appropriate for a direct final rule because it is intended to make 
noncontroversial changes to existing regulations, and we do not 
anticipate receiving any significant adverse comments. 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.
    Consistent with our procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule. The companion proposed rule provides the procedural 
framework within which the rule may be finalized in the event the 
direct final rule is withdrawn because of any significant adverse 
comment. The comment period for this direct final rule runs 
concurrently with the comment period of the companion proposed rule. 
Any comments received in response to the companion proposed rule will 
also be considered as comments regarding this direct final rule.
    We are providing a comment period on the direct final rule of 75 
days after the date of publication in the Federal Register. If we 
receive any significant adverse comment, we intend to withdraw this 
direct final rule before its effective date by publication of a notice 
in the Federal Register within 30 days after the comment period ends. 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 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 Administrative Procedure Act (APA) (5 U.S.C. 
553). Comments that are frivolous, insubstantial, or outside the scope 
of the rule will not be considered significant or adverse under this 
procedure. A comment recommending an additional change to the rule will 
not be considered a significant adverse 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.
    If any significant adverse comments are received during the comment 
period, we will publish, before the effective date of the direct final 
rule, a document withdrawing the direct final rule. If we withdraw the 
direct final rule, all comments received will be considered under the 
companion proposed rule in developing a final rule using the usual 
notice-and-comment procedures under the APA (5 U.S.C. 552 et seq.). If 
we receive no significant adverse comment during the specified

[[Page 16925]]

comment period, we intend to publish a document in the Federal Register 
confirming the effective date within 30 days after the comment period 
ends.

III. Analysis of Impacts

    FDA has examined the impacts of the final 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 final 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 this rule does not impose any significant 
costs, we certify that it 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 
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 direct final rule contains no 
collection 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 direct final rule 
is of a type that does 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 direct final rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this direct final rule does not contain policies that 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 have concluded this direct final 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 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, 21 CFR part 
20 is amended as follows:

PART 20--PUBLIC INFORMATION

0
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.


0
2. Amend Sec.  20.108 as follows:
0
a. Revise paragraph (b);
0
b. Remove paragraph (c);
0
c. Redesignate paragraph (d) as paragraph (c);
0
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 FDA 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 FDA 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. 2012-6967 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P


