[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53560-53569]
[FR Doc No: 2019-21769]

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DEPARTMENT OF TRANSPORTATION

Information Dissemination Quality Guidelines

AGENCY: Office of the Secretary of Transportation, US Department of
Transportation.

ACTION: Updated guidelines.

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SUMMARY: The U.S. Department of Transportation (DOT) is issuing updated
guidelines to implement section 515 of the Treasury and General
Government Appropriations Act for FY 2001. The Office of Management and
Budget (OMB) has issued Government-wide guidelines under Section 515
which direct each Federal agency to establish and implement written
procedures to ensure and maximize the quality, utility, objectivity and
integrity of the information that they disseminate. OMB has directed
each agency to update its guidelines in accordance with the
requirements of OMB Memorandum M-19-15.

DATES: Comments are due November 6, 2019.

ADDRESSES: You may send comments, identified by DOT-OST-2019-0135, by
any of the following methods:

     Follow the instructions for sending comments on
www.regulations.gov, or email<EMAIL_ADDRESS>Include DOT-OST-2019-
0135 in the subject line of the message.
     Mail: Docket Management Facility; U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE, West Building, Room
W12-140, Washington, DC 20590-0001.
     Hand Delivery/Courier: Room W12-140 on the ground level of
DOT, West Building, 1200 New Jersey Avenue SE, Washington, DC, between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays.
    Instructions: All submissions received must include the agency name
and docket number for this notice. All comments received will be posted
without change to www.regulations.gov, including any personal
information provided.
    Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov at any time or to Room
W12-140 on the ground level of DOT, West Building, 1200 New Jersey
Avenue SE, Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except Federal holidays. If you wish to receive
confirmation of receipt of your written comments, please include a
self-addressed, stamped postcard with the following statement:
``Comments on DOT-OST-2019-0135.'' The Docket Clerk will date stamp the
postcard prior to returning it to you via the U.S. mail. Please note
that due to possible delays in the delivery of U.S. mail to federal
offices in Washington, DC, we recommend that persons consider an
alternative method (internet, or professional delivery service) of
submitting comments to the docket and ensuring their timely receipt at
DOT.

FOR FURTHER INFORMATION CONTACT: Daniel Morgan, Chief Data Officer,
OST, Department of Transportation at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>For specific inquiries on the Department's
administration mechanisms for seeking correction of information covered
by these guidelines, or for specific inquiries about the Department's
statistical guidelines, please refer to the contacts listed in the
guidelines.

SUPPLEMENTARY INFORMATION: Pursuant to Section 515 of the Treasury and
General Government Appropriations Act for Fiscal Year 2001 (Pub. L.
106-554), and consistent with the Office of Management and Budget's
(OMB) ``Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of Information Disseminated by
Federal Agencies,'' and OMB Memorandum M-19-15, ``Improving
Implementation of the Information Quality Act,'' the Department is
revising its Information Dissemination Quality Guidelines (Guidelines).
These guidelines were originally issued in 2002. The Department's
Guidelines apply to a wide variety of its information dissemination
activities to meet basic information quality standards. The Guidelines
provide a framework under which the Department allows affected persons
an opportunity to seek and obtain correction of information maintained
and disseminated by the Department that does not comply with these
guidelines.
    The written procedures established within DOT's guidelines apply to
the following organization components of the Department: The Office of
the Secretary, the Federal Aviation Administration, the Federal Motor
Carrier Safety Administration, the Federal Railroad Administration, the
Federal Transit Administration, the Maritime Administration, the
National Highway Traffic Safety Administration, the Pipeline and
Hazardous Materials Safety Administration, and the Saint Lawrence
Seaway Development Corporation.
    The updated guidelines are available on the Department's website at
https://www.transportation.gov/dot-information-dissemination-quality-guidelines and in the docket. The Department seeks comment on the
guidelines and the proposed changes.

    Authority: Issued in Washington, DC on October 1, 2019.
Ryan Cote,
Chief Information Officer, Department of Transportation, Office of the
Secretary.

The Department of Transportation's Information Dissemination Quality
Guidelines

What is the purpose of this posting?

    Consistent with The Office of Management and Budget's (OMB)
Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity of Information Disseminated by Federal Agencies
implementing Section 515 of the Treasury and General Government
Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554) and the
requirements outlined in OMB Memorandum M-19-15, Improving
Implementation of the Information Quality Act, the U.S. Department of
Transportation (henceforth DOT or Department) is updating guidelines
explaining how the Department will ensure the quality of disseminated
information. This document also explains how affected persons may seek
and obtain corrections of information that does not comply with these
Information Quality guidelines.

What version are these guidelines?

    These Guidelines were originally published on October 1, 2002 and
were updated on October 1, 2019.

When are these guidelines effective?

    These Guidelines are effective October 1, 2019.

Who should be contacted for further information about these guidelines?

    Daniel Morgan, Assistant Chief Information Officer for Data
Services/Chief Data Officer<EMAIL_ADDRESS>or<PHONE_NUMBER>. For
inquiries on the Department's administrative mechanisms for persons to
seek correction of information, please contact the Office of the
General Counsel,<PHONE_NUMBER>. For inquiries on the guidelines
concerning statistical disseminated information, contact the Bureau of
Transportation Statistics, U.S. Department of Transportation; 800-853-
1351 or 202-366-DATA (3282). Written correspondence may be addressed to
the U.S. Department of Transportation, Office of the Chief Information
Officer (S-80), 1200 New Jersey Avenue SE, Washington, DC, 20590.

Contents

1. What is the background and purpose of these guidelines?
2. To which DOT operating administrations do these guidelines apply?
3. What are the scope, nature and legal effect of these guidelines?
    Scope
    Influential Information
    Protecting Data
    Nature and Legal Effect
4. What types of information are not subject to these guidelines?
5. What general standards of quality are DOT operating administrations
implementing?
    Utility
    Objectivity
    Integrity
    Accessibility
    Public Access to Government Information (Open Data)
    Re-use of Existing DOT Program Data
6. What additional standards of quality are DOT operating
administrations implementing for statistical information?
7. What processes does DOT utilize to ensure information quality before
it is disseminated?

8. What are DOT's procedures concerning requests for correction of
information?
    May I request a correction of information from the Department?
    Where do I submit a request for correction of information?
    How does the Department process incoming requests for correction?
    What should you include in a request for correction of information?
    May the Department reject a request for correction of information?
    Who has the burden of proof with respect to corrections of
information?
    What determinations does the Department make concerning a request
for correction of information?
    How does the Department process requests for correction concerning
information on which the Department has sought public comment?
    How may I appeal the Department's decision on a request for
correction?
9. What are the department's reporting requirements?
10. What are the definitions associated with these guidelines?

1. What is the background and purpose of these guidelines?

    The Department of Transportation (DOT) is updating guidelines
originally released in 2002 to implement Section 515 of the Treasury
and General Government Appropriations Act for Fiscal Year 2001 (Pub. L.
106-554). The Office of Management and Budget (OMB) previously issued
guidelines under Section 515 which direct Federal agencies subject to
the Paperwork Reduction Act (44 U.S.C. Chapter 35) to establish and
implement written guidelines to ensure and maximize the quality,
utility, objectivity and integrity of the information that they
disseminate. These updated 2019 DOT guidelines apply to a wide variety
of substantive information dissemination activities to meet basic
information quality standards set forth by Section 515. Under Section
515, the Department is responsible for carrying out the OMB information
quality guidelines as well as for implementing its own guidelines that
are set forth in this document. Consequently, when this document refers
to ``the guidelines,'' it should be taken to refer to the OMB
guidelines, as applied to DOT programs and activities, as well as the
2019 DOT guidelines themselves, unless the context suggests otherwise.
    The purpose of these 2019 DOT guidelines is to provide a framework
for DOT's compliance with the OMB guidelines, and to provide affected
persons an opportunity to seek and obtain correction of information
maintained and disseminated by DOT that does not comply with these
guidelines. DOT has designated the Departmental Chief Information
Officer (CIO) as the senior official responsible for DOT compliance
with these guidelines. Administrators of DOT's Operating
Administrations (OAs) are also responsible for ensuring proper
implementation of these Departmental guidelines. The CIO is responsible
for the Office of the Secretary's compliance.
    In implementing these guidelines, the Department acknowledges that
ensuring the quality of information is an important management
objective that takes its place concurrently with other Departmental
objectives, such as ensuring the success of agency missions, observing
budget and resource priorities and restraints, and providing useful
information to the public.
    These guidelines were updated in 2019 to reflect current procedures
and compliance with OMB's Memorandum M-19-15. Implementation updates
from that memorandum are footnoted where they are addressed in this
update.

2. To which DOT operating administrations do these guidelines apply?

    These guidelines apply to the Office of the Secretary of
Transportation (OST) and to the following DOT OAs.

 Federal Aviation Administration (FAA)
 Federal Highway Administration (FHWA)
 Federal Motor Carrier Safety Administration (FMCSA)
 Federal Railroad Administration (FRA)
 Federal Transit Administration (FTA)
 Maritime Administration (MARAD)
 National Highway Traffic Safety Administration (NHTSA)
 Pipeline and Hazardous Materials Safety Administration (PHMSA)
 Saint Lawrence Seaway Development Corporation (SLSDC)

    DOT OAs may adopt further guidance, consistent with these
guidelines, to address the specifics of their programs and information
products.

3. What are the scope, nature and legal effect of these guidelines?

Scope

    These guidelines apply to certain information (including both
statistical and non-statistical data, as well as computer software
(including code) as defined in 48 CFR 27.401 and 48 CFR 2.101 and in
accordance with the Federal Source Code Policy). These guidelines apply
to information disseminated by DOT on or after October 1, 2002,
regardless of when the information was first disseminated. Maintenance
of information on DOT websites or paper files does not, in itself,
subject information disseminated before this date to the guidelines.
However, information that the Department maintains in a way that is
readily available to the public and that continues to play a
significant, active role in Department program or in private sector
decisions is subject to the guidelines. These guidelines apply to
information dissemination in all media (printed, electronic, or in
other form). When the Department has performed analysis using a
specialized set of computer code, the computer code used to process it
should be made available to the public for further analysis, if
consistent with applicable law and policy.\1\ As is the intent of OMB's
guidelines, DOT's guidelines will focus primarily on the dissemination
of substantive information (e.g., reports, tabular and geospatial
datasets, analyses, studies, summaries) rather than information
pertaining to basic agency operations.
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    \1\ Implementation Update 3.2, OMB Memorandum M-19-15, April 24,
2019.
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    The standards of these guidelines apply only to information that
DOT generates. However, these guidelines serve as recommendations for
information that external sources provide to DOT, if the external
parties seek to have the Department rely upon or disseminate this
information or the Department decides to do so. When using non-
government sources to create influential information (as defined below)
that is communicated to the public, DOT will include sufficient
information on the characteristics of the data and analysis, including
its scope, generation protocols, and any other information necessary to
allow the public to reproduce that source's conclusions.\2\ For
example, suppose that a trade association, in commenting on a proposed
rule, supplies a scientific or technical study or an economic analysis
in support of its position on what the final rule should say. For DOT
to rely on this information in a subsequent DOT dissemination of
information (e.g., as part of the basis cited for decisions in the
final rule), the quality of the trade association's information would
have to be consistent with these guidelines. Likewise, if the
Department

disseminates information originally created by, for example, a
contractor or consultant, these guidelines would apply. The types of
Departmental information not subject to these guidelines are outlined
in Section 4.
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    \2\ Implementation Update 3.3, OMB Memorandum M-19-15, April 24,
2019.
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Influential Information

    The OMB guidelines and subsequent Information Quality Bulletin for
Peer Review define ``influential information'' as information that the
agency reasonably can determine ``will have or does have a clear and
substantial impact on important public policies or important private
sector decisions.'' This definition applies only to scientific,
financial, or statistical information. DOT defines ``scientific
information'' as in the Information Quality Bulletin for Peer Review
(excerpted below) and notes that DOT considers financial and
statistical information to be types of scientific information.

    ``The term ``scientific information'' means factual inputs, data,
models, analyses, technical information, or scientific assessments
based on the behavioral and social sciences, public health and medical
sciences, life and earth sciences, engineering, or physical sciences.
This includes any communication or representation of knowledge such as
facts or data, in any medium or form, including textual, numerical,
graphic, cartographic, narrative, or audiovisual forms. This definition
includes information that an agency disseminates from a web page, but
does not include the provision of hyperlinks to information that others
disseminate. This definition does not include opinions, where the
agency's presentation makes clear that what is being offered is
someone's opinion rather than fact or the agency's views.''

    Note that the definition above applies to information itself, not
to decisions that the information may support. The guidelines assign to
DOT the task of defining ``influential information'' in ways
appropriate to the agency and its various programs.
    At DOT, influential information may be used to support rulemakings,
regulatory actions, and analysis or other purposes. Every decision DOT
makes based on disseminated information is important to someone. That
does not mean that disseminated information used for each decision is
influential, as the term is used in the guidelines.
    In rulemakings, influential information is scientific, financial,
or statistical information that can reasonably be regarded as being one
of the major factors in the resolution of one or more key issues in a
significant rulemaking, as that term is defined in Executive Order
12866. DOT's interpretation of influential information reflects the
``clear and substantial impact'' language in the OMB guidelines
language. The reference to key issues on significant rules reflects the
``important'' public policy language of the guidelines.
    In non-rulemaking contexts, DOT considers two factors in
determining whether information is influential.
     Breadth: Influential information affects a broad number
and/or range of stakeholders or parties (e.g., an entire industry or a
significant part of an industry, as opposed to a single company). In
making this determination, the Department would also evaluate the
overall magnitude of the impact of the information, not only its impact
on a per capita or per unit basis.
     Impact: Influential information has a substantial
economic, regulatory, or behavioral impact, as determined by the DOT
Component. In considering whether information has a substantial impact,
DOT Components consider the same kinds of factors that cause a rule to
be an economically significant rule as defined in Executive Order
12866. DOT-initiated or sponsored distribution of influential
information may be novel, controversial, and/or precedent-setting.
    When DOT substantially changes information that it disseminates,
such as through a change in information collected under the Paperwork
Reduction Act (PRA), DOT will re-evaluate the information disseminated
to determine whether it is influential. DOT reserves the right to
designate other information as influential provided the information is
scientific, financial, or statistical, although Components should not
designate information products or types of information as influential
without consultation with the Department Chief Information Officer.

Protecting Data

    DOT is prioritizing increased access to the data and analytic
frameworks (e.g., models) used to generate influential information.
Data disclosures will be consistent with statutory, regulatory, and
policy requirements for protections of privacy and confidentiality,
proprietary data, and confidential business information.\3\ DOT uses
and continues to explore methods that provide wider access to datasets
while reducing the risk of disclosure of personally identifiable
information (PII) and/or sensitive data. Implementation of these
approaches (e.g., tiered access) is consistent with principles for
ethical governance, which include employing sound data security
practices, protecting individual privacy, maintaining appropriate
confidentiality, and ensuring appropriate access and use.\4\ These
methods apply to both government and non-government information and
data used in the development of influential information and data. DOT
retains data in accordance with established records schedules and the
DOT Records Management Policy (DOT Order 1351.28).\5\
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    \3\ Implementation Update 3.4, OMB Memorandum M-19-15, April 24,
2019.
    \4\ Implementation Update 3.5, OMB Memorandum M-19-15, April 24,
2019.
    \5\ https://www.transportation.gov/digitalstrategy/policyarchive/Records-Management.
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    Nature and Legal Effect
    These guidelines are policy views of DOT. They are not intended to
be, and should not be construed as, legally binding regulations or
mandates. These guidelines are intended only to improve the internal
management of DOT and do not create any right or benefit, substantive
or procedural, enforceable at law or equity, by any party against the
United States, its agencies (including DOT or any Component), officers,
or employees, or any person.
    This guidance is not legally binding in its own right and will not
be relied upon by the Department as a separate basis for affirmative
enforcement action or other administrative penalty. Conformity with
this guidance is voluntary only and nonconformity will not affect
rights and obligations under existing statutes and regulations.

4. What types of information are not subject to these guidelines?

    The following information is not subject to these guidelines:
     Distribution of information that is intended to be limited
to government employees, agency contractors or grantees;
     Distribution of information that is intended to be limited
to intra- or inter- agency use or sharing of government information;
responses to requests under FOIA, Privacy Act, the Federal Advisory
Committee Act or other similar laws;
     Predisclosure Notification to Submitters of Confidential
Commercial Information (49 CFR 7.29);
     Distribution limited to correspondence with individuals or
persons (regardless of medium, e.g., email). The possibility of further
distribution by the recipient does not

cause such correspondence to be subject to these guidelines. However,
information sent by letter to a wide variety of individuals (e.g., a
``Dear Colleague'' letter sent to heads of all recipients of financial
assistance from a DOT OA) would be subject to coverage under these
guidelines;
     Archival records disseminated by Federal agency libraries,
websites, or similar Federal data repositories; (e.g., inactive or
historical materials in DOT libraries and other data collections--
including bibliographies or responses to reference requests pertaining
to such materials);
     Public filings, such as material filed by DOT or non-DOT
parties in DOT dockets or by DOT in other agencies' dockets. For
example, a study filed in the DOT docket by a commenter on a proposed
rule does not become subject to these guidelines simply because it has
been filed there. However, if the Department chooses to rely on the
study in the rulemaking or another information product, the study would
become subject to these guidelines because of the Department's use of
it;
     Contents of the National Transportation Library that are
not products of DOT-funded research or DOT-funded data collections.
     Information intended to be limited to subpoenas and
adjudicatory processes. These processes would include:
    1. Court or administrative litigation (e.g., briefs and
attachments, or other information that the Department submits to the
court or other decision maker);
    2. Administrative enforcement proceedings conducted by the
Department;
    3. Civil rights and personnel complaints and reviews conducted by
the Department (e.g., under Titles VI and VII of the Civil Rights Act;
the Americans with Disabilities Act; Sections 501, 504 and 508 of the
Rehabilitation Act of 1973; Title IX of the Education Amendments of
1972, and Disadvantaged Business Enterprise matters);
    4. Debarment and suspension matters, 49 CFR part 29 (Federal-aid
contracts) and 48 CFR part 9 (direct contracts);
    5. Merit System Protection Board matters (Sections 7511, 7543, and
70701 of Title 5, United States Code);
    6. Locomotive engineer certification matters, 49 CFR part 240,
subpart E-Dispute Resolution procedures;
     Hyperlinks to information that others disseminate (as well
as paper-based information from other sources referenced but not
adopted or endorsed by DOT);
     Views or opinions, where the presenter makes it clear that
what is being offered is someone's opinion rather than fact or the
Department's views;
     Information presented to Congress as part of the
legislative or oversight processes (e.g., testimony of DOT officials,
information or drafting assistance provided to Congress about pending
or proposed legislation or oversight) that has previously been subject
to the guidelines, is primarily a statement of the views of the
Department on an issue, or is provided to a member of Congress who then
disseminates it publicly. However, the Department would treat studies
or other information products that are presented to Congress, and that
have not previously been subject to these guidelines, as being covered.
     Press releases and other information of an ephemeral
nature, advising the public of an event or activity of a finite
duration--regardless of medium. Information products referenced in such
releases may be subject to the guidelines, however (e.g., a study
referred to in a press release); and
     Procedural, operational, policy, and internal manuals
prepared for the management and operations of DOT that are not
primarily intended for public dissemination. This includes personnel
notices such as vacancy announcements.

5. What general standards of quality are DOT operating administrations
implementing?

    DOT has traditionally utilized standards, policies, and other
operational guidelines to ensure the quality of all its disseminated
information. Incorporating these guidelines further reinforces DOT's
commitment of meeting higher standards of quality prior to
disseminating information to the public. The Department has made
implementation of these guidelines a part of its performance plan,
including performance goals and standards.
    To ensure compliance with these guidelines, each DOT Component is
responsible for appointing a data quality official who will serve as
the liaison for implementing these guidelines within its organization.
    OMB's guidelines define ``quality'' as an encompassing term
comprising utility, objectivity, and integrity. Therefore, the
guidelines sometimes refer to these statutory terms, collectively, as
``quality.'' At a minimum, a basic standard of quality is established
for all DOT information prior to its dissemination. In addition,
repeatedly or continuously disseminated information is reviewed on a
regular basis to ensure all information is current and complies with
these guidelines. Specifically, DOT will set the following standards at
levels appropriate to the nature and timeliness of substantive
information to be disseminated.

Utility

    DOT Components will assess the usefulness of the information to be
disseminated to the public. The originating office will continuously
monitor the information needs and develop new sources or revise
existing methods, models, and information products where appropriate.
    DOT's policy is to disseminate information in machine-readable and
open formats, to the greatest extent possible, such that the
information that can be easily consumed by a wide external audience.
DOT's Data Management Policy (DOT Order 1351.34) outlines requirements
for interoperability and standardization of data and information.
    DOT's policy is to provide the public with sufficient documentation
about each dataset released to allow data users to determine the
fitness of the data for the purpose for which third parties may
consider using it.\6\ DOT may employ templates or frameworks provide
data users with the relevant information.
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    \6\ Implementation Update 2.2, OMB Memorandum M-19-15, April 24,
2019.
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Objectivity

    DOT Components will ensure disseminated information is accurate,
clear, complete, and unbiased in substance and presentation, and
presented in a proper context. The originating office will use reliable
data sources and sound analytical techniques. Quality control
procedures will be included when data is created or processed. To the
extent possible and consistent with confidentiality protections, the
originating office will identify the source of disseminated information
so that the public can assess whether the information is objective. The
2012 version of DOT's Scientific Integrity Policy,\7\ states:
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    \7\ Available at https://www.transportation.gov/sites/dot.gov/files/docs/mission/administrations/assistant-secretary-research-and-technology/282391/scientificintegritypolicy.pdf.

    ``The Department is dedicated to preserving the integrity of the
research it conducts and funds. It will not tolerate misconduct in
the performance of these activities nor in the application of these
activities to decision-making. Political appointees at DOT should
never suppress or

alter research findings or conclusions. Political appointees are not
to censure or coerce DOT employees to alter scientific findings.
This policy encompasses all sciences including hard, natural and
life, and social sciences, and all findings including results
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derived from data (actual or simulated).''

    DOT employees are prohibited from any behavior that attempts to
inappropriately alter the scientific process or to suppress, fabricate,
or falsify scientific findings.
    The Department follows a policy of determining, in consultation as
appropriate with relevant scientific and technical communities, when it
is useful and practicable to apply reproducibility standards to
original and supporting data. In making such determinations, the
Department will be guided by commonly accepted scientific, financial or
statistical standards, as applicable. The Department's Scientific
Integrity Policy guides its scientific research. With respect to
analytic results, the Department's policies favor sufficient
transparency about methods to allow independent reanalysis by qualified
members of the public. In situations where public access will not occur
(e.g., because of confidentiality requirements or the use of
proprietary models), the Department's policy is to apply and document
especially rigorous robustness checks.
    In OMB's guidelines, one of the aspects of ensuring objectivity
concerns the use of peer review. For information products to which peer
review is relevant, OMB's guidelines create a rebuttable presumption
that the information meets the OMB guidelines' objectivity standards if
the data and analytic results have been subject to formal, independent,
external peer review. Anyone seeking to rebut this presumption (i.e.,
as part of the request for correction process) would have the
obligation of demonstrating that the information was not substantively
accurate, clear, complete, or unbiased, both as to substance and
presentation, and in a proper context.
    With respect to influential scientific information disseminated by
the DOT Components regarding analysis of risks to human health, safety,
and the environment, DOT Components will adopt, with respect to the
analysis in question, quality principles of the Safe Drinking Water Act
of 1996 (42 U.S.C. 300g-1(b)(3)(A) & (B), except where the agency
adapts these principles to fit the needs and character of the analysis.
These principles are as follows:
     Use the best available science and supporting studies
conducted in accordance with sound and objective scientific practices,
including peer-reviewed studies where available.
     Use data collected by accepted methods or best available
methods, in accordance with all applicable standards (if the
reliability of the method and the nature of the decision justifies the
use of the data), and document methods used in metadata which
accompanies disseminated datasets.
     In the dissemination of influential scientific information
about risks, ensure that the presentation of information is
comprehensive, informative, and understandable, and that influential
information is accompanied by a clear explanation of underlying
assumptions. In a document made available to the public, specify, to
the extent practicable:
    1. Each population addressed by any estimate of applicable effects.
    2. The expected risk or central estimate of risk for the specific
populations affected.
    3. Each appropriate upper bound or lower-bound estimate of risk.
    4. Each significant uncertainty identified in the process of the
risk assessment and studies that would assist in reducing the
uncertainty.
    5. Any additional studies, including peer-reviewed studies, known
to the agency that support, are directly relevant to, or fail to
support the findings of the assessment and the methodology used to
reconcile inconsistencies in the scientific data.
    In 2019, DOT revisited the parameters for identifying and
disseminating influential information. DOT will provide guidance for
determining the amount and type of pre-dissemination review necessary,
specific types of information that are influential and a rigorous
process for determining whether types of information not specifically
listed in the guidelines qualify as influential.\8\ DOT will ensure
that influential information is communicated transparently by including
a clear explication of underlying assumptions, accurate
contextualization of uncertainties, and a description of the
probabilities associated with both optimistic and pessimistic
projections, including best-case and worst-case scenarios.\9\
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    \8\ Implementation Update 1.1, OMB Memorandum M-19-15, April 24,
2019.
    \9\ Implementation Update 3.1, OMB Memorandum M-19-15, April 24,
2019.
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    Prior to dissemination, all influential information produced by the
DOT shall be peer reviewed by subject matter experts (may be either
internal or external to DOT, or both) that have not participated in the
preparation of the influential information being reviewed. When using
scientific information, including third-party data or models, to
support their policies, DOT will comply with the requirements of OMB's
Information Quality Bulletin for Peer Review. DOT will ensure reviewers
are asked to evaluate the objectivity of the underlying data and the
sensitivity of conclusions to analytic assumptions. Furthermore, when
influential information that has been peer-reviewed changes
significantly, DOT will conduct a second peer review.\10\ Peer review
will also apply to influential information in economically significant
regulations under Executive Order 12866.
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    \10\ Implementation Updates 1.2-1.4, OMB Memorandum M-19-15,
April 24, 2019.
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Integrity

    DOT's policy is to ensure that information is protected from
unauthorized access, corruption or revision (i.e., make certain
disseminated information is not compromised through corruption or
falsification). The Department will apply appropriate protections to
information as determined by DOT policy. DOT Components will comply
with relevant Department policies that protect the integrity of
information, including but not limited to:

     DOT Order 1351.18, Departmental Privacy Risk Management
Policy
     DOT Order 1351.37, Departmental Cybersecurity Policy

Accessibility

    DOT's policy is to ensure that all disseminated information
(including electronic and web-based media) is accessible to all
persons. DOT Components will comply with relevant Departmental policies
that ensure the accessibility of disseminated information, including
but not limited to DOT Order 1351.23, Electronic and Information
Technology (EIT) Accessibility Policy.

Public Access to Government Information (Open Data)

    When DOT makes available information originally collected by
another agency, the contributing agency is responsible for the quality
of the information they contribute, and DOT will clearly communicate
that responsibility.
    DOT's policy is to provide the public with sufficient documentation
about each dataset to allow data users to determine fitness for
purpose. DOT will, when applicable, safeguard privacy and

confidentiality when releasing data. DOT Components will comply with
the DOT Order 1351.34, Departmental Data Management Policy, when
disseminating, sharing, safeguarding, and evaluating data and
information.

Re-Use of Existing DOT Program Data

    DOT will:
     Consider potential for using existing data sources from
inside and outside the agency for statistical and research purposes,
while protecting privacy and confidentiality.
     Solicit comments about downstream uses from statistical,
research, and evaluation agencies/offices when designing or improving
data collection systems.
     Coordinate with the Senior Agency Official for Privacy if
considering secondary analysis that involves PII.
     Develop procedures for clearly documenting the quality of
administrative data that have the potential to be used for statistical
purposes.\11\
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    \11\ Implementation Updates 2.3-2.6, OMB Memorandum M-19-15,
April 24, 2019.
---------------------------------------------------------------------------

    DOT's Data Management Policy (DOT Order 1351.34) also provides
detailed information regarding re-use of data and information.

6. What additional standards of quality are DOT operating
administrations implementing for statistical information?

    The Bureau of Transportation Statistics (BTS) provides additional
guidance for statistical information. Under 49 U.S.C. 6302(b)(3)(B),
the BTS Director is required to:
     Continually improve surveys and data collection methods of
the Department to improve the accuracy and utility of transportation
statistics;
     Encourage the standardization of data, data collection
methods, and data management and storage technologies for data
collected by the Bureau; the operating administrations of the
Department (OAs); State and local governments; metropolitan planning
organizations; and private sector entities;
     Build and disseminate the transportation layer of the
National Spatial Data Infrastructure. . . including by coordinating the
development of transportation geospatial data standards, compiling
intermodal geospatial data, and collecting geospatial data that is not
being collected by other entities;
     Issue guidelines for the collection of information by the
Department that the BTS Director determines necessary to develop
transportation statistics and carry out modeling, economic assessment,
and program assessment activities to ensure that such information is
accurate, reliable, relevant, uniform, and in a form that permits
systematic analysis by the Department;
     Review and report to the Secretary on the sources and
reliability of the statistics proposed by the heads of the OAs of the
Department to measure outputs and outcomes as required by the
Government Performance and Results Act of 1993 (Pub. L. 103-62; 107
Stat. 285); and at the request of the Secretary, any other data
collected or statistical information published by the heads of the OAs
of the Department; and
     Ensure that the statistics published under [49 U.S.C.
6302] are readily accessible to the public, consistent with applicable
security constraints and confidentiality interests.
    BTS has published a Statistical Standards Manual,\12\ a Guide to
Good Statistical Practice in the Transportation Field,\13\ and a
Confidentiality Policy.\14\ BTS maintains these documents to reflect
current statistical policies and methods regarding data quality and
confidentiality as well as challenges related to new data sources and
analytical methods. The most current version of these manuals and
guides applies.
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    \12\ Available at https://www.bts.gov/learn-about-bts-and-our-work/statistical-methods-and-policies/bts-statistical-standards-manual.
    \13\ Available at https://www.bts.gov/archive/publications/guide_to_good_statistical_practice_in_the_transportation_field/index.
    \14\ Available at https://www.bts.gov/confidentiality.
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    As one of the 13 principal federal statistical agencies, BTS
adheres to all Statistical Policy Directives of the Office of
Management and Budget (OMB). These directives are published at https://www.whitehouse.gov/omb/information-regulatory-affairs/statistical-programs-standards/.

7. What processes does DOT utilize to ensure information quality before
it is disseminated?

    DOT's policy is to conduct a pre-dissemination review on all
information it disseminates on or after October 1, 2002. During this
review, each DOT organization shall conduct subject matter expert
(internal or external, or both) peer reviews and other review
mechanisms to ensure the quality of all disseminated information. The
costs and benefits of using a higher quality standard or a more
extensive review process will be considered in deciding the appropriate
level of review and documentation. With respect to information
collection requirements covered by the PRA, the Department will ensure
that these requirements are consistent with the guidelines and will so
state in the PRA submission to OMB. The main components of DOT's pre-
dissemination review policy are:
     Allow adequate time for reviews, consistent with the level
of standards required for the type of information to be disseminated.
Consult with other stakeholders who have a substantial interest in the
proposed dissemination of the information.
     Verify compliance with these guidelines (i.e., utility,
objectivity, integrity and accessibility requirements) as well as other
DOT organization specific guidance/procedures;
     With respect to information a DOT organization believes to
be influential, maintain internal records of what additional standards
will be applied to ensure its quality.
     Ensure that the entire information product fulfills the
intentions stated and that the conclusions are consistent with the
evidence;
     Indicate origin of data (when including data from an
external source); and
     Ensure that each program office can provide additional
data or metadata on the subject matter of any covered information it
disseminates.

8. What are DOT'S procedures concerning requests for correction of
information?

    You may request the correction of information from the Department,
but not all requests for correction fall under these Guidelines. For
instance:
     The DOT maintains certain information about individuals in
its systems of records that those individuals may know or suspect is
inaccurate, irrelevant, untimely, or incomplete. In such cases, the
Privacy Act permits those individuals to request that the DOT correct
or amend the information. To learn more about your rights under the
Privacy Act, please visit: https://www.transportation.gov/privacy.
     The DOT maintains information in support of its basic
agency operations that relevant parties may have an opportunity to
correct. In such cases, individual DOT programs may develop their own
review and redress procedures that are not subject to these Guidelines.
To learn more about such programs, please visit the website of the
relevant DOT OA.
    To request correction of information that is subject to these
Guidelines, follow the procedures below.

May I request a correction of information from the Department?

    You may request that the Department correct information
disseminated after October 1, 2002. Information originally disseminated
before October 1, 2002, is subject to this correction process if it
remains publicly available (e.g., it is posted on a DOT website or the
Department makes it available on a generally distributed information
source) and it continues to play a significant, active role in
Department programs or in private sector decisions. If data or
information is already covered by an existing quality review process,
it will be addressed by that process and not by the correction of
information procedure described here. If the information relates to a
final Environmental Impact Statement (EIS), the DOT organization may
handle the request as though it were a request for a Supplemental EIS.

Where do I submit a request for correction of information?

    You may make a request for correction of information or request for
reconsideration by emailing<EMAIL_ADDRESS>If you wish to
use postal mail, please send your request to: U.S. Department of
Transportation (DOT), Docket Management, Re: Request for Correction of
Information under the Information Quality Act, West Building, Room W12-
140, 1200 New Jersey Avenue SE, Washington, DC 20590.

How does the Department process incoming requests for correction?

    We will post incoming requests for correction, requests for
reconsideration and DOT organizational responses on the Federal Dockets
Management System.
    You should be aware that the Department is not required to change,
or in any way alter, the content or status of information simply based
on the receipt of a request for correction. Nor does the receipt of a
request, or consideration by the Department, result in staying or
changing any action of the Department. The receipt of a request for
correction likewise does not affect the finality of any decision of a
DOT Component.

What should you include in a request for correction of information?

    You should:
     Include a statement that you are submitting a request for
correction of information under DOT's Information Dissemination Quality
Guidelines.
     Include your name, mailing address, email address,
telephone number and organizational affiliation, if any.
     Describe how the information in question affects you
(e.g., how an alleged error harms you, and/or how the correction will
benefit you).
     Clearly identify the report, dataset, or other document
that contains the information you want the Department to correct.
Please include identifying characteristics such as title, date, and how
information was accessed.
     Not rely solely on general statements that allege some
type of error. You should specify, in detail, why you believe the
information in question is inconsistent with the Department's and/or
OMB's information quality guidelines (i.e., how the information fails
to meet standards of integrity, utility, and/or objectivity).
     Include any documents and/or evidence you believe is
relevant to your request (e.g., comparable data or research results on
the same topic).
     Specify what corrections you wish for DOT to make to the
information and why the recommended corrections would make the
information more consistent with DOT's and/or OMB's information quality
guidelines.

May the Department reject a request for correction of information?

    Once the appropriate data quality official has received your
request for correction of information s/he will review your request and
answer the following questions to determine if your request for
correction is valid:
    1. Did DOT (as opposed to some other person or organization)
disseminate the information you are requesting to be corrected?
    2. Is the information about which you are requesting a correction
from DOT covered by these Guidelines (see Section 4)?
    3. Is your request frivolous or not germane to the substance of the
information in question?
    4. Has DOT responded previously to a request that is the same or
substantively very similar? (Note: This does not mean that the
Department would automatically reject a second or subsequent
information correction request concerning the same information product.
If one party made a request concerning one aspect of the information
product, and a second party made a request concerning a different
aspect of the same product, the two requesters are seeking correction
on different grounds and it could be appropriate for the Department to
consider both).
    5. With respect to information in a final rule, final environmental
impact statement, or other final document on which there was an
opportunity for public comment or participation with respect to the
compliance of the information with these guidelines, could interested
persons have requested the correction of the information at the
proposed stage?
    If the DOT organization determines that the answer to 1,2, or 3 is
``no'' or that the answer to Question 4, 5, or 6 is ``yes,'' DOT has
the discretion to reject your request without responding to it on its
merits.
    If DOT rejects your request, the DOT OA will send a written
response explaining why. Normally, the DOT OA will send this response
within 60 calendar days of receiving your request. The DOT OA will file
this response in the Federal Docket Management System. If the DOT
organization does not reject your request, it will consider the request
on its merits. DOT will not opine on the requestor's or DOT's policy
position. DOT's response will contain a point-by-point response to any
data quality arguments contained in the request for correction and will
refer to a peer review that directly considered the issue being raised,
if available. Prior to the release to the requestor, DOT will share a
draft response with OMB for assessment of compliance with the above
norms.\15\
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    \15\ Implementation Updates 4.2-4.4, OMB Memorandum M-19-15,
April 24, 2019.
---------------------------------------------------------------------------

Who has the burden of proof with respect to corrections of information?

    As the requester, you bear the burden of proof with respect to the
necessity for correction as well as with respect to the type of
correction you seek.

What determinations does the Department make concerning a request for
correction of information?

    If DOT considers your request on its merits (that is, does not
reject it for one of the reasons stated above), DOT will make the
determination whether information subject to the DOT information
quality guidelines complies with the guidelines. In doing so, the
Department will consider whether the information or the request for
correction is stale. If DOT did not disseminate this information
recently (i.e., within one year of your request), or it does not have a
continuing significant impact on DOT projects or policy decisions or on
important private sector decisions, we may regard the information as
stale for purposes of responding to a correction request, unless the
requestor can show that he or she is affected by its dissemination. If
we determine that

information subject to the 2019 DOT guidelines does not comply with the
guidelines, the Department will decide what correction is appropriate
to make to ensure compliance. While the Department's policy is to
correct existing information when necessary, the Department is not
obligated to generate new or additional information to respond to
requests for correction.
    The DOT provides a response directly to the requestor. This
response will normally be issued within 60 calendar days of receiving
the request. If the response will take significantly longer, DOT will
inform the requester that more time is required and indicate the reason
why and an estimated decision date. DOT will not take more than 120
days to respond without first seeking the concurrence of the
requester.\16\ This written explanation to the requestor will also be
filed in the Federal Dockets Management System.
---------------------------------------------------------------------------

    \16\ Implementation Update 4.1, OMB Memorandum M-19-15, April
24, 2019.
---------------------------------------------------------------------------

How does the Department process requests for correction concerning
information on which the Department has sought public comment?

    Information in rulemakings and other documents concerning which
public participation and comment are sought are subject to these
guidelines. However, the Department may respond to requests for
correction concerning such information through a different process than
we use for other types of information. When the Department seeks public
comment on a document and the information in it (e.g., a notice of
proposed rulemaking (NPRM), studies cited in an NPRM, a regulatory
evaluation or cost-benefit analysis pertaining to the NPRM; a draft
environmental impact statement; a proposed policy notice or aviation
order on which comment has been sought; a request for comments on an
information collection subject to the Paperwork Reduction Act), there
is an existing mechanism for responding to a request for correction.
This mechanism is a final document that responds to public comments
(e.g., the preamble to a final rule). Consequently, our response to a
request for correction of such information will normally be
incorporated in the next document we issue in the matter.
    The Department would consider making an earlier response, if doing
so (1) would not delay the issuance of the final action in the matter;
and (2) the Department determined that there would be an unusually
lengthy delay before the final document would be issued or the
requester had persuaded the Department that there was a reasonable
likelihood that the requester would suffer actual harm if the
correction were not made before the final action was issued.
    Once again, the DOT organization will place its response in the
Federal Dockets Management System. As noted above, a DOT Component may
reject a request for correction with respect to information in a final
document if there was an opportunity for public comment or
participation with respect to the compliance of information to these
guidelines and interested persons could have requested the correction
of the information at the proposed stage.

How may I appeal the Department's decision on a request for correction?

    You may request reconsideration under this section if you have
requested a correction of information under these guidelines, and you
are not satisfied with the DOT organization's response. You should
request reconsideration within 30 days of the date you received the DOT
Component's decision on your original request for correction.
    You should send your request in the same manner, and to the same
address, as provided above.
    DOT will assign an official or establish a reconsideration panel to
determine if additional corrective action is needed, and will issue a
written response to the requestor stating the reasons for the decision.
DOT will share a draft response of the appeal with OMB prior to release
to the requestor for assessment of compliance with the above norms. To
protect the integrity of the appeals process, DOT will ensure that
individuals reviewing and responding to the appeals request were not
involved in the review and initial response to the request for
correction.\17\
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    \17\ Implementation Updates 4.4-4.5, OMB Memorandum M-19-15,
April 24, 2019.
---------------------------------------------------------------------------

    This guidance is non-regulatory and is not intended to constitute a
set of legally binding requirements. However, DOT may be unable to
process requests that omit one or more of the requested elements. DOT
will attempt to contact and work with requesters to obtain additional
information when warranted.
    The Department maintains records of all corrections and appeals
requests. These records may contain contact information provided by you
as authorized by Section 515 of the Treasury and General Government
Appropriations Act for Fiscal Year 2001 \18\ (Pub. L. 106-554, codified
at 44 U.S.C. 3516). Contact information is needed to respond to your
request and initiate follow-up contact with you if necessary. We may
disclose part of the records relating to a correction or correction
appeals, including requestor contact information to a congressional
office in response to an inquiry made on your behalf, to the Department
of Justice, a court, other tribunal when the information is relevant
and necessary to litigation, or to a contractor or another Federal
agency to help accomplish a function related to this process.
---------------------------------------------------------------------------

    \18\ https://www.govinfo.gov/content/pkg/PLAW-106publ554/pdf/PLAW-106publ554.pdf.
---------------------------------------------------------------------------

9. What are the department's reporting requirements?

    The Departmental Office of the Chief Information Officer will
provide annual reports to OMB, including the number and nature of
complaints received concerning agency compliance as well as how
complaints were resolved.

10. What are the definitions associated with these guidelines?

    DOT has adopted the definitions of terms set forth in The Office of
Management and Budget's Guidelines for Ensuring and Maximizing the
Quality, Objectivity, Utility, and Integrity of Information
Disseminated by Federal Agencies. The following information explains
further the way that DOT uses some of these terms.
    Reproducibility. Documented methods are capable of being used on
the same data set to achieve a consistent result. For more information
on this term, please refer to OMB's guidelines.
    Dissemination. As provided in OMB's guidelines, these guidelines
apply only to information disseminated on or after October 1, 2002. The
fact that an information product that was disseminated by DOT before
this date is still maintained by the Department (e.g., in DOT's files,
in publications that DOT continues to distribute on a website) does not
make the information subject to these guidelines or to the request for
correction process. As noted above, the Department's policy is to treat
as subject to the guidelines information that we maintain in a way that
is readily available to the public and that continues to play a
significant, active role in Department programs or in private sector
decisions.
    For example, suppose that DOT first issued a study in 1999. The
study is relied upon in a 2000 DOT organization publication, and the
DOT organization makes the publication available on its website. This
study is not subject to these guidelines or to the request for
correction process just because it is ``archived'' in an available
paper publication or website. However, if DOT

issues a notice of proposed rulemaking in 2003 that relies on the same
study, then it becomes subject to these guidelines--because it then has
been disseminated (or, one might say ``re-disseminated'') after October
1, 2002.
    Departmental Components. Offices, divisions, Operating
Administrations (OAs) and comparable elements of the DOT.
    Departmental Chief Information Officer (CIO). The Departmental CIO
is the senior management official responsible for the DOT Information
Dissemination Quality Program.
    Data Quality Administrator (DQA). Designated representative in the
Office of the CIO responsible for compiling agency reports and serving
as agency liaison to OMB.
    Data Quality Official (DQO). The DQO serve as the point of contact
for the Departmental CIO/Data Quality Administrator and will be
responsible for implementing these guidelines within their
organization.
    Federal Docket Management System. An electronic, image-based
database in which all DOT docketed information is stored for easy
research and retrieval.
    Docket. A docket is an official public record. DOT publishes and
stores online information about proposed and final regulations, copies
of public comments on proposed rules, and related information in the
Federal Docket Management System. DOT uses this docketed material when
making regulatory and adjudicatory decisions, and makes docketed
material available for review by interested parties. Specific documents
covering the same issues are stored together in a docket.

[FR Doc. 2019-21769 Filed 10-4-19; 8:45 am]
 BILLING CODE P


[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7446-7447]
[DOCID:fr17fe09-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0013]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Sterility Test
General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 8: Sterility Test General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Sterility Test General Chapter
harmonized text from each of the three pharmacopoeias (United States,
European, and Japanese) represented by the Pharmacopoeial Discussion
Group (PDG). The draft guidance conveys recognition of the three
pharmacopoeial methods by the three ICH regulatory regions and provides
specific information regarding the recognition. The draft guidance is
intended to recognize the interchangeability between the local regional
pharmacopoeias, thus avoiding redundant testing in favor of a common
testing strategy in each regulatory region. This draft guidance is the
eighth annex to the core Q4B guidance, which was made available in the
Federal Register of February 21, 2008 (73 FR 9575).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by April 20, 2009.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring,

MD 20993-0002; or the Office of Communication, Training and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. The guidance may also be obtained
by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. Send two
self-addressed adhesive labels to assist the office in processing your
requests. Submit written comments on the draft guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H.
King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Christopher Joneckis,
Center for Biologics Evaluation and Research (HFM-25), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In November 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 8: Sterility Test General
Chapter'' should be made available for public comment. The draft
guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Sterility Test General Chapter
harmonization proposal originating from the three-party PDG. This draft
guidance is in the form of an annex to the core ICH Q4B guidance. Once
finalized, the annex will provide guidance to assist industry and
regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3167 Filed 2-13-09; 8:45 am]

BILLING CODE 4160-01-S