[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50589-50591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20610]


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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: Final rule.

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SUMMARY: This final rule makes technical changes that will update a 
requirement that many of the written agreements and memoranda of 
understanding (MOUs) between the Food and Drug Administration (FDA) and 
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 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.

DATES: This rule is effective October 22, 2012.

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, 
daniel.sigelman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Rulemaking Procedure

    In the Federal Register of March 23, 2012 (77 FR 16923), FDA 
published a direct final rule to eliminate the requirement that many of 
our written agreements and MOUs with other departments, Agencies, and 
organizations be published in the Federal Register. We explained that 
we issued this rule as a direct final rule because we believed it was 
noncontroversial and did not anticipate receiving significant adverse 
comments. We concurrently published in the Federal Register of March 
23, 2012 (77 FR 16971) a companion proposed rule, substantively 
identical to the direct final rule, that provided a procedural 
framework from which to proceed with standard notice-and-comment 
rulemaking in the event we were required to withdraw the direct final 
rule because of significant adverse comments. 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. Any 
comments received under the companion proposed rule were treated as 
comments regarding the direct final rule and vice versa. A full 
description of FDA's policy on direct final rule procedures may be 
found in a guidance document published in the Federal Register of 
November 21, 1997 (62 FR 62466). This guidance document may be accessed 
at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
    We received one comment on the proposed rule, which we considered 
significantly adverse. Therefore, in the Federal Register of June 27, 
2012 (77 FR 38173), we withdrew the direct final rule. This final rule 
summarizes and responds to this comment on the direct final rule and 
proposed rule. See section IV of this document for a discussion of the 
comment and FDA's response.

II. 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 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.

III. Summary of the Final Rule

    This 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 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 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/

[[Page 50590]]

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 Reading 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 48794; September 20, 1993). This 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 final rule does not amend Sec.  20.108(a) (stating that our 
written agreements and MOUs are available for public disclosure).

IV. Comment on the Proposed Rule and FDA's Response

    We received one comment on the proposed rule. A summary of that 
comment and FDA's response follow.
    (Comment 1) While acknowledging ``FDA's efforts to reduce printing 
costs associated with publication of newly completed'' agreements and 
MOUs, the comment urged that such documents be published in full in the 
Federal Register, as they constitute ``vital aspects of FDA's 
mission,'' and the Federal Register has been designated as the one 
place where important governmental actions can be found. The comment 
maintained that the Federal Register embodies a permanently available 
historical record providing potentially necessary details for 
recreating Agency thinking or policy at a given time. By contrast, the 
comment continued, FDA removes obsolete documents from its Web site as 
it continuously updates it, thereby rendering that Web site unreliable 
as an Agency historical record. It additionally contended that on 
numerous occasions when FDA has updated its Web site, information has 
become difficult to find or links no longer connect to appropriate Web 
site pages.
    (Response) We believe that the burden and costs imposed by Federal 
Register publication of agreements and MOUs, which include not only the 
printing costs acknowledged by the comment, but also the time of FDA 
staff and associated government paperwork, outweigh any arguable 
interest in reproducing these documents in their entirety in the 
Federal Register. To the extent that any of these documents are 
eventually no longer accessible on FDA's Web site, they, like numerous 
other significant documents that are not reprinted in the Federal 
Register, constitute permanent Agency records required to be archived 
and made available to the public on request.

V. 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 $139 million, using the most current (2011) 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.

VI. Paperwork Reduction Act of 1995

    We have concluded that this 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.

VII. Environmental Impact

    We have determined under 21 CFR 25.33 that this 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.

VIII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that this 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 that this 
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.

[[Page 50591]]

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. Section 20.108 is amended 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 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: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20610 Filed 8-21-12; 8:45 am]
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