[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33196-33197]
[FR Doc No: 2014-13434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1558]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
10, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0673.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry and Food and Drug Administration Staff on Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products--(OMB Control Number 0910-0673)--(Extension)

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by adding a new chapter granting
FDA authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the form for the submission of
information related to substantial equivalence. In a level 1 guidance
document issued under the Good Guidances Practices regulation (21 CFR
10.115), FDA provides recommendations intended to assist persons
submitting reports under section 905(j) of the FD&C Act and explains,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence.
    In the Federal Register of December 27, 2013 (78 FR 78974), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Six comment submissions were received, some
of which included multiple comments. Two of the six comment submissions
were in favor of FDA's regulation of tobacco products. Three comment
submissions were considered to contain PRA-related comments and three
comment submission were not considered to contain PRA-related comments.
The three comment submissions not considered to contain PRA-related
comments are beyond the scope of this Federal Register notice.
    (Comment 1) One commenter supported FDA in its mission to regulate
tobacco products for the benefit of public health and safety and
indicated that language in the guidance be strengthened to assist in
FDA reviews. The commenter also suggested that the respondents provide
additional information to minimize future Freedom of Information Act
requests.
    (Response 1) FDA agrees that the request in this collection of
information is necessary to fulfill the requirements of the FD&C Act.
The type of data for a given new product may vary depending on whether
the characteristics of the product are the same or different from a
predicate tobacco product, and the information is needed to allow FDA
to make informed decisions when reviewing a substantial equivalence
application.
    (Comment 2) Several commenters indicated that FDA has improperly
implemented the substantial equivalence provisions of the statute (the
FD&C Act, as amended by the Family Smoking Prevention and Tobacco
Control Act (FSPTCA)), and maintain that FDA is asking for reports that
are neither authorized nor relevant to a substantial equivalence
determination.
    (Response 2) FDA disagrees with the comment. The information FDA is
requesting is related to new products using the substantial equivalence
pathway to assist FDA in making a determination of whether a product is
substantially equivalent.
    (Comment 3) Several commenters asserted that FDA was not asking for
enough information, while other commenters asserted that FDA was asking
for too much information.
    (Response 3) FDA believes that the collection of information is
necessary and the burden estimates are appropriate and reflect the
amount of time a respondent would need to prepare a substantial
equivalence submission.
    (Comment 4) One commenter noted that under FDA's interpretation,
every new, including modified, product

automatically will be evaluated. Other commenters questioned FDA's
implementation and Congress' intent of the FSPTCA and its definition of
substantial equivalence and new products.
    (Response 4) The FD&C Act as amended by the FSPTCA establishes the
definition of ``new tobacco product'' and the premarket pathways, of
which substantial equivalence is one. FDA believes the information
collection estimates are appropriate and reflect estimates of the time
it would take to put together and report the information needed in a
substantial equivalence submission required by the statute.
    (Comment 5) One commenter stated that the commenter believes that
substantial equivalence reports should be exempt from environmental
assessment requirements.
    (Response 5) The National Environmental Policy Act and FDA
implementing regulations require environmental assessment requirements.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                         FD&C Act sections                              Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a).........................................           1,000                1            1,000              360          360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates
that it will receive 1,000 section 905(j) reports each year and that it
will take a manufacturer approximately 360 hours to prepare a report of
substantial equivalence for a new tobacco product. Therefore, FDA
estimates the burden for submission of substantial equivalence
information will be 360,000 hours.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13434 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


these issues are moot. However, while the EPA is not finalizing the
provisions in 40 CFR 30.6 that include the term uncertainty, the EPA is
responding to these comments because the term uncertainty is used in 40
CFR 30.5. The EPA is also responding to comments on the proposed 40 CFR
30.6 provision incorporated as part of 40 CFR 30.5.
    Some commenters contended that the EPA's use of the term
``uncertainty'' at 40 CFR 30.6 is vague. A few other commenters
contended that the EPA should include specific requirements in 40 CFR
30.6 as to the scope of an analysis of uncertainty. The EPA disagrees
with the suggestion that the term ``uncertainty'' is vague or that
there is significant ambiguity about what should be in the scope of a
characterization of uncertainty. The characterization of uncertainty is
a key factor in the assessments that the EPA conducts. It is a
component of various EPA guidelines (e.g., Framework for Human Health
Risk Assessment to Inform Decision Making, Ref. 36) that the EPA relies
upon in conducting its assessments. The scope of the uncertainty
analyses that the EPA conducts necessarily varies across assessments
and actions. The intent of this regulation is not to force uncertainty
analyses into a one-size-fits-all approach, as that is not practical,
good policy, or good science. Thus, a regulation of internal
procedures, such as this one, does not require a regulatory definition
for a term that is already a key component of current EPA practices and
guidelines and EPA's assessment process.
    Several commenters contended that the proposed 40 CFR 30.6
requirement that the EPA give explicit consideration to high quality
studies that explore a broad range of parametric dose-response or
concentration-response models and to non-parametric models that
incorporate fewer assumptions could force the EPA into situations in
which it applies dose-response model(s) that are not appropriate for
the data being assessed. The EPA notes that the final regulatory text
in 40 CFR 30.5 does not require that a specific type of dose-response
model be applied to a particular situation. Rather, in determining the
consideration to afford pivotal science for which the dose-response
data are not available for independent validation, the EPA will
evaluate, as appropriate, the extent to which the study considered a
broad range of parametric dose-response or concentration-response
models, a robust set of potential confounding variables, nonparametric
models that incorporate fewer assumptions, various threshold models
across the dose or exposure range, and models that investigate factors
that might account for spatial heterogeneity.

G. Administrator's Exemption

    In the 2018 proposed rule, the EPA proposed that the Administrator
could grant case-by-case exemptions to the requirements in proposed 40
CFR part 30 when compliance with those requirements is impracticable
(proposed 40 CFR 30.9). In the 2020 SNPRM, the EPA modified proposed 40
CFR 30.9 to be consistent with other changes proposed in the 2020
SNPRM, such that the Administrator could grant case-by-case exemptions
to the requirements in proposed 40 CFR part 30 under specific
conditions for which compliance with the requirements in proposed 40
CFR part 30 is impracticable.
    Some commenters supported the Administrator's exemption provision
in proposed 40 CFR 30.9 while others opposed it. Commenters expressing
support for the exemption provision noted that exemptions may be needed
to account for lawful and reasonable restrictions on underlying data
and models. Commenters expressing opposition to the exemption provision
raised concerns about the Administrator granting exemptions from the
requirements in proposed 40 CFR part 30. These commenters contended
that the Administrator may lack the scientific expertise to make the
appropriate exemption decisions and that the Administrator, as a
political appointee, could be biased. Some public commenters
recommended that the exemption process require formal consultation with
EPA career scientists, the EPA's SAB, or another Agency advisory
committee.
    The EPA also received comment on the following proposed conditions

under which the Administrator could grant an exception in the 2020
SNPRM: Technological barriers render sharing of the data or models
infeasible; the development of the data or model was completed or
updated before the effective date of the final rule; or making the data
and models available would conflict with laws governing privacy,
confidentiality, CBI, or national security. Some commenters supported
the condition that would allow the Administrator to grant an exemption
based on the age of a study, noting that older studies may not have
been conducted with the intention of providing access to underlying
data and models for independent validation, particularly at the stage
of data and models proposed in the 2020 SNPRM. Other commenters opposed
this condition, contending that exempting studies based on the age of
the study is unnecessary and undermines the goal of increasing
transparency in the development of regulatory decisions. Some
commenters noted it may be prohibitively expensive for researchers to
make their data and models available.
    The EPA finds that these comments have merit, in part. The Agency
agrees with retaining the Administrator's exemption provision because
there are conditions under which compliance with the requirements in 40
CFR part 30 might be impracticable. For example, the underlying dose-
response data for some studies, particularly older studies, may not be
readily publicly available because of the technological barriers to
data sharing (e.g., differences in data storage devices or data
retention practices) that existed when they were developed. As a
result, the EPA is finalizing the Administrator's exemption provision
as proposed in the 2020 SNPRM, with additional conditions described
here. Due to other changes described in this preamble, the
Administrator's exemption provision, which was previously in 40 CFR
30.9 in the 2018 proposed rule and the 2020 SNPRM, is now 40 CFR 30.7
in the final rule.
    The EPA does not agree with the comments regarding the role of the
Administrator in determining whether to grant an exemption and finds
that the Administrator is the appropriate decision maker in this
context. To ensure that the Administrator's decision is appropriately
transparent, in the final rule the EPA has included a provision in 40
CFR 30.7 that requires the Agency to document the rationale for any
exemptions granted by the Administrator in the significant regulatory
action or influential scientific information. This documentation would
typically be provided as part of the proposed rulemaking, given that it
would be part of the decision concerning what is the pivotal science
for the rule. Regardless of what is provided in the proposed rule stage
of the rulemaking, the final rulemaking will provide clear
documentation.
    Some commenters and the EPA's SAB (Ref. 27) also requested that the
EPA include criteria that the Administrator will consider when
determining whether to grant exemptions from the requirements in 40 CFR
part 30. The EPA finds that these comments have merit and is including
additional criteria in 30 CFR 30.7 that may be used by the
Administrator when he or she is determining whether greater
consideration should be afforded to pivotal science for which the
underlying dose-response data are not available in a manner sufficient
for independent validation. As a result, the Administrator may also
determine that greater consideration is warranted when a third party
has independently validated the underlying dose-response data through
reanalysis or when the EPA's evaluation of the factors in 40 CFR
30.5(d) indicate that full consideration of the pivotal science is
justified.
    To assist the Administrator in determining whether to grant an
exemption, the EPA program or Region responsible for the significant
regulatory action or influential scientific information and public
commenters can provide input when the Administrator is considering an
exemption. The EPA will document the rationale for the Administrator's
exemption in the significant regulatory action or influential
scientific information. The EPA is confident that the above criteria
provide sufficient clarity and boundaries for the Administrator to
consider when granting an exemption under 40 CFR 30.7.

H. Peer Review

    In the 2018 proposed rule and the 2020 SNPRM, the EPA proposed to
require independent peer review on pivotal regulatory science and
pivotal science. The EPA also proposed to require that the Agency ask
peer reviewers to opine on the strengths and weaknesses of the EPA's
justifications for the assumptions used in models.
    Some commenters on the 2018 proposed rule and 2020 SNPRM
specifically asked why the EPA would need to peer review health and
scientific studies and scientific literature that had already undergone
independent peer review. They stated that the EPA failed to explain why
existing peer review requirements and mechanisms are insufficient. Such
commenters also noted that in addition to being duplicative and
unnecessary, the proposed requirement would cause unnecessary delays in
the EPA actions and would result in increased costs for the Agency. One
commenter noted that the EPA already has policies in place for peer
review and referred to the EPA's Peer Review Handbook (Ref. 44).
Another commenter stated that, while it is certainly best practice to
consider only science that has been independently peer reviewed when
making regulatory decisions, that does not necessitate independent peer
review by the EPA. The commenter noted that most scientific bodies and
publications--including Nature, Science, the Bipartisan Policy Center,
and Proceedings of the National Academy of Sciences--employ some of the
most robust peer review practices and that they already apply to the
types of studies which the proposed rule would require the EPA to peer
review anew. Some commenters also stated that the proposed peer review
requirements specific to assumptions used in models suggest that the 40
CFR 30.7 regulatory text would require that the EPA conduct peer review
of the proposed Agency action itself, rather than of the science
underlying that action. One of the commenters contended that it is
entirely unclear how peer review could be applied to EPA's reasoning
itself, rather than the pivotal science supporting the regulatory
decision.
    The EPA finds that these comments have merit, in part. However, in
this rule, the EPA is not changing the pre-existing requirements of the
OMB Final Information Quality Bulletin for Peer Review (Ref 8). The
preamble of the Bulletin states that ``the intensity of peer review is
highly variable across journals'' and ``prior peer review and
publication is not by itself sufficient grounds for determining that no
further review is necessary'' (Ref. 8). Peer review does not typically
include reanalysis of the underlying data (i.e., the proper stage of
data where the data that are ready to be analyzed to extract relevant
information) and, thus, peer review is not considered a replacement for
the data availability requirements of this rule.
    The EPA is, therefore, finalizing the language at 40 CFR 30.6
(formerly 40 CFR 30.7 in the 2018 proposed rule and the 2020 SNPRM) to
clarify that the Agency will evaluate whether or not to initiate peer
review, consistent with the OMB Final Information Quality Bulletin for
Peer Review (Ref. 8) and the EPA's Peer Review Handbook (Ref. 44), of

individual studies identified as pivotal science if the studies have
already undergone journal peer review. If the Agency conducts peer
review on pivotal science, the EPA shall ask peer reviewers to
articulate the strengths and weaknesses of the justification for the
assumptions applied in analyzing dose-response data and the
implications of those assumptions for the results.

I. Changes to 40 CFR 30.4 ``What requirements apply to EPA's use of
studies in significant regulatory actions? ''

    In the 2018 proposed rule, the EPA proposed to require at 40 CFR
30.4 that ``EPA shall clearly identify all studies (or other regulatory
science) relied upon when it takes any final action. The EPA should
make all such studies available to the public to the extent
practicable.'' Some commenters expressed concern that proposed 40 CFR
30.4 would permit the Agency to exclude valid studies from
consideration on the basis of the availability of underlying data or
models. Another commenter noted that this section would apply to any
final agency action, rather than regulatory decisions. In response to
these comments, the EPA notes that this section does not require the
EPA to exclude studies from consideration when developing final
significant regulatory actions either on the basis of the availability
of underlying data or models, or depending on the practicability of
making these studies available to the public.
    The EPA agrees with the commenter that the scope of 40 CFR 30.4
should be limited to significant regulatory actions, which are defined
in 40 CFR 30.2 as ``final regulations determined to be `significant
regulatory actions' by the Office of Management and Budget pursuant to
Executive Order 12866.'' The EPA is finalizing additional changes to
the title and body of 40 CFR 30.4 by using terms defined in 40 CFR
30.2. In the title of 40 CFR 30.4, the EPA is replacing ``taking final
action'' with ``significant regulatory actions'' to improve clarity and
specificity, since the latter term is defined. In the body of 40 CFR
30.4, the EPA is replacing ``all studies (or other regulatory science)
relied upon when it takes any final agency action'' with ``science that
serves as the basis for informing a significant regulatory action'' to
improve specificity, since the latter language is defined; replacing
``should'' with ``shall;'' ``studies'' with ``science that serves as
the basis for informing a significant regulatory action'' to improve
specificity, since the latter term is defined; and ``available to the
public'' with ``publicly available'' to improve specificity, since the
latter term is defined. Together, these changes are meant to clarify
that the requirements of 40 CFR 30.4 are consistent with the EPA's
existing practice of making science that serves as the basis for
informing a significant regulatory action available in the public
docket as part of the rulemaking.

J. Benefits and Costs

    In the 2018 proposed rule, as part of its E.O. 12866 and E.O. 13563
reviews, the EPA stated that the benefits of the proposal justify the
costs. The EPA's rationale was that the rule would facilitate expanded
data sharing and exploration of key data sets, improve the ability to
independently validate analyses underlying significant regulatory
actions, and would be implemented in a cost-effective way. The 2020
SNPRM did not provide additional characterizations of benefits and
costs. A number of commenters noted that the EPA did not provide an
economic assessment to support the Agency's benefit-cost claims.
Commenters also noted that the EPA did not characterize costs to the
Agency, including administrative costs to ascertain the public
availability of underlying data, costs for additional analyses
required, and costs to ensure that PII and CBI are not disclosed. Other
commenters noted that the EPA had not adequately explained the benefits
of this rule, including enabling increased secondary analyses by third
party researchers.
    The EPA agrees that neither the 2018 proposed rule nor the 2020
SNPRM included a characterization of costs to the Agency. The EPA
emphasizes that this is a rule of internal procedure promulgated under
the EPA's housekeeping authority. However, the EPA has identified some
incremental costs that the Agency may incur as a result of this final
rule. As stated in Section III.A.2 of this preamble, the EPA will
continue its current practice of conducting extensive review of
scientific studies during the development of significant regulatory
actions and influential scientific information. The additional
procedures required by this rule apply only to pivotal science, which
is a subset of the total number of studies that the EPA would evaluate.
Given the costs of the current robust process for identifying and
reviewing scientific studies and documentation that are existing Agency
practice, as well as that the determination of dose-response data
availability is limited to pivotal science underlying significant
regulatory actions and influential scientific information, the EPA
anticipates that the incremental costs of this rule will be small. The
Agency may also incur other administrative costs to perform analyses
and evaluations to support activities such as exemption decisions made
by the Administrator, and documenting these or other decisions made
pursuant to the requirements of the final rule. Again, the Agency
anticipates that the incremental costs for these activities will be
small relative to current administrative costs for developing
significant regulatory actions or influential scientific information.
Finally, this final rule does not require the EPA to disclose or host
data, but to determine if dose-response data are available and to give
greater consideration to those studies for which such data are
available. Hence, this rule does not impose costs on the EPA or any
other party to make data available, including costs to ensure that PII
and CBI are not disclosed. The Agency may opt, at its discretion, to
incur the costs associated with making data available when it is in the
public interest to do so, but that will be decided on a case-by-case
basis and is not a requirement of the final rule.
    The EPA also agrees that the benefits of the rule were not fully
characterized in the 2018 proposed rule or the 2020 SNPRM. The EPA
emphasizes, however, that this is a rule of internal procedure
promulgated under the EPA's housekeeping authority. As discussed in
Section III.A.1 of this preamble, the main benefits of this rule spring
from greater transparency in significant regulatory actions and
influential scientific information. By placing greater emphasis on the
availability of dose-response data underlying pivotal science, the rule
will allow for greater scientific scrutiny as EPA decision makers are
developing significant regulatory actions and influential scientific
information and increases the likelihood that any errors will be
identified and corrected. Greater transparency is also inherently
valuable as a principle of good government and provides benefits to the
public at large, including reducing the risk of errors in EPA analyses
and in the science such analyses rely upon. The ability for independent
subject matter experts to validate pivotal science will facilitate more
effective comment and engagement with the public during development of
future significant regulatory actions and influential scientific
information.
    Some commenters further argued that the EPA failed to account for
costs external to the EPA as consequence of

this rule, including costs to third party researchers and their
institutions to make their raw data available and protect PII/CBI
through data-masking, de-identification, or deposition in public data
repositories. The EPA disagrees with the argument that this rule would
impose costs on third-party researchers. This is a rule of internal
procedure that does not impose requirements on any party other than the
EPA. This rule imposes no costs on researchers or their institutions,
and the EPA will consider and evaluate all relevant and appropriate
science in its significant regulatory actions and influential
scientific information. The EPA recognizes that researchers and other
third parties may voluntarily consider the EPA's position on data
availability, as described in this rule, as they make their own
decisions about how to conduct research and the extent to which they
make data and models available. Researchers may choose to make more
data and models available, but the EPA recognizes that these parties
will weigh their own benefits and costs and make choices that they deem
appropriate.
    Some commenters argued the 2018 proposed rule and the 2020 SNPRM
would impose costs on third parties because it would prohibit the EPA
from using necessary science where the underlying data and models are
not publicly available, which would prevent the EPA from meeting its
statutory obligations and performing its mission of protecting human
health and the environment. Some commenters also contended that the
proposed rule requirements would impose costs to the public by delaying
EPA regulatory actions that protect human health and the environment.
    As described earlier, the EPA acknowledges and agrees with
commenters that there may be pivotal science where the underlying data
are not publicly available or available through restricted access. The
final rule is limited to dose-response data and, as no studies are
categorically excluded from consideration, the EPA will continue to
rely on the full body of the highest quality, most relevant studies
available in determining the potential for hazard due to exposure to a
pollutant, contaminant, or substance. Consistent with the requirements
of this rule, the EPA will identify a subset of those studies based on
the exposure situation being addressed, the quality of the studies, the
reporting adequacy, and the relevance of the endpoints that would
inform a dose-response assessment, and will give greater consideration
to pivotal science for which the underlying dose-response data are
available. The EPA disagrees with commenters that the requirements of
this rule will result in any meaningful delay in promulgating
regulations. While this final rule requires the Agency to evaluate the
availability of dose-response data for pivotal science, the incremental
burden to the Agency to carry out these requirements is expected to be
small given (1) the extensive scientific review the EPA already
conducts regularly and (2) that the requirement is limited to pivotal
science (i.e., typically a small, though highly important, subset of
the studies the EPA would review). Further, with this final rule, the
EPA is maintaining language in 40 CFR 30.3 stating that the statutes
that the EPA administers, or their implementing regulations, will
control in the event of any conflicts with the requirements of this
rule. The Agency will continue to comply with and abide by the
requirements in those statutes and implementing regulations, including
regulatory deadlines.

K. Proposed 40 CFR 30.8 ``How is EPA to account for cost under this
subpart?''

    In 2018, the EPA proposed in 40 CFR 30.8 that ``EPA shall implement
the provisions of this subpart in a manner that minimizes costs.'' A
number of commenters argued that this statement was vague and that the
2018 proposed rule neither explained what costs this rule would incur,
nor how they would be minimized. One commenter further raised concern
that, in order to minimize costs, proposed 40 CFR 30.8 may require the
EPA to exclude valid data from consideration rather than take
potentially expensive steps to protect CBI, proprietary data, and PII.
Still other commenters interpreted proposed 40 CFR 30.8 as requiring
the EPA to base its final significant regulatory actions and
influential scientific information on cost. Commenters expressed
concern that this would be at the exclusion of considerations such as
the best available science and public health. A commenter further
argued that the EPA does not have the statutory authority to base its
assessment of science on cost without consideration of public health
and environmental costs and benefits and privacy-related costs and
benefits, and that doing so would be irrational and arbitrary.
    As explained in Section III.J of this preamble, this rule of
internal procedure is anticipated to incur small incremental costs
related to the additional review of data availability, as compared to
the Agency's existing costs for extensive review and documentation as
part of the development of significant regulatory actions and
influential scientific information. In consideration of the public
comments, however, the EPA is not finalizing proposed 40 CFR 30.8 ``How
is EPA to account for cost under this subpart?'' This rule is not
intended to require the EPA to exclude valid data from consideration on
the basis of cost, nor interpret the EPA's statutory authority to
consider costs in significant regulatory actions or influential
scientific information. Given the EPA's existing commitment to fulfill
its duties in a cost-effective manner, the EPA has determined not to
finalize proposed 40 CFR 30.8.

IV. References

    The following is a listing of the documents that are specifically
referenced in this notice. The docket includes these documents and
other information considered by EPA, including documents referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.

1. E.O. 13777, Enforcing the Regulatory Reform Agenda, 82 FR 12285
(March 1, 2017), available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.
2. E.O. 13783, Promoting Energy Independence and Economic Growth, 82
FR 16093 (March 31, 2017), available at https://www.federalregister.gov/documents/2017/03/31/2017-06576/promoting-energy-independence-and-economic-growth.
3. Office of Mgmt. & Budget, Exec. Office of the President,
Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity of Information Disseminated by Federal
Agencies, 67 FR 8451 (February 22, 2002), available at https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.
4. Office of Mgmt. & Budget, Exec. Office of the President, Open
Data Policy--Managing Information as an Asset, OMB M-13-13 (May 9,
2013), available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2013/m-13-13.pdf.
5. U.S. EPA. Strengthening Transparency in Regulatory Science;
Proposed Rule, 83 FR 18768 (April 30, 2018) (FRL-9977-40), available
at https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science.
6. U.S. EPA. Strengthening Transparency in Regulatory Science;
Proposed Rule, 83 FR 24255 (May 25, 2018) (FRL-9978-31),

available at https://www.federalregister.gov/documents/2018/05/25/2018-11316/strengthening-transparency-in-regulatory-science-extension-of-comment-period-and-notice-of-public.
7. U.S. EPA. Strengthening Transparency in Regulatory Science;
Supplemental Notice of Proposed Rulemaking, 85 FR 15396 (March 18,
2020) (FRL-10004-72-ORD), available at https://www.federalregister.gov/documents/2020/03/18/2020-05012/strengthening-transparency-in-regulatory-science.
8. Office of Mgmt. & Budget, Exec. Office of the President, Final
Information Quality Bulletin for Peer Review, 70 FR 2664 (January
14, 2005), available at https://www.federalregister.gov/documents/2005/01/14/05-769/final-information-quality-bulletin-for-peer-review.
9. U.S. EPA. (2016). Plan to Increase Access to Results of EPA-
Funded Scientific Research. (EPA/601-R-16-005). Washington, DC: U.S.
Environmental Protection Agency. Available at https://www.epa.gov/sites/production/files/2016-12/documents/epascientificresearchtransperancyplan.pdf.
10. U.S. EPA. (2018). Open Government Plan 5.0. Washington, DC: U.S.
Environmental Protection Agency. Available at https://www.epa.gov/sites/production/files/2018-10/documents/epaopengovplanversion5_0final.pdf.
11. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
10-06, Open Government Directive (December 8, 2009), available at
https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2010/m10-06.pdf.
12. Office of Science and Technology Policy. (2013). Memorandum for
the Heads of Executive Departments and Agencies: Increasing Access
to the Results of Federally Funded Scientific Research. Available at
https://www.epa.gov/sites/production/files/2015-01/documents/ostp_memo_increasing_public_access.pdf.
13. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
19-23, Phase 1 Implementation of the Foundations for Evidence-Based
Policymaking Act of 2018--Learning Agendas, Personnel, and Planning
Guidance (July 10, 2019), available at https://www.whitehouse.gov/wp-content/uploads/2019/07/M-19-23.pdf.
14. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
20-12, Phase 4 Implementation of the Foundations for Evidence-Based
Policymaking Act of 2018--Program Evaluation Standards and Practices
(March 10, 2020), available at https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-12.pdf.
15. McNutt, M. (2016). Taking up TOP. Science 352, 1147. Available
at https://doi.org/10.1126/science.aag2359.
16. NAS (National Academies of Sciences, Engineering, and Medicine).
(2019). Reproducibility and replicability in science. Washington,
DC: The National Academies Press. Available at https://www.nationalacademies.org/our-work/reproducibility-and-replicability-in-science.
17. Nosek, B.A. et al. (2015). Promoting an open research culture.
Science 348, 1422-1425. Available at https://doi.org/10.1126/science.aab2374.
18. Office of Mgmt. & Budget, Exec. Office of the President, OMB M-
19-15, Improving Implementation of the Information Quality Act
(April 24, 2019), available at https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-15.pdf.
19. Calabrese, E.J. (2019). EPA transparency proposal: Testimony of
Edward J. Calabrese, Ph.D., October 3, 2018. J Cell Commun Signal.
13(1): 145-147. https://doi.org/10.1007%2Fs12079-018-0497-8.
20. Perrone, J. (2014). Secrets are no fun. The Hill. Available at
https://thehill.com/blogs/congress-blog/energy-environment/224583-secrets-are-no-fun.
21. U.S. Congress. (2010). Current Science on Public Exposures to
Toxic Chemicals: Hearing before the Subcommittee on Superfund,
Toxics and Environmental Health of the Committee on Environment and
Public Works, 111th Congress. Available at https://www.govinfo.gov/content/pkg/CHRG-111shrg21160/html/CHRG-111shrg21160.htm.
22. U.S. Congress. (2010). Letter to EPA Administrator Jackson.
Available at https://assets.documentcloud.org/documents/1202768/letter-from-congress-to-lisa-jackson-on-arsenic.pdf.
23. U.S. Congress. (2011). EPA's IRIS Program: Evaluating the
Science and Process Behind Chemical Risk Assessment: Hearing before
the Subcomm. on Oversight & Investigations of the H. Comm. on
Science, Space, & Technology, 112th Cong. Available at https://www.govinfo.gov/content/pkg/CHRG-112hhrg67255/html/CHRG-112hhrg67255.htm.
24. McNutt, M. (2014). Journals unite for reproducibility. Science
346(6210): 679. Available at https://doi.org/10.1126/science.aaa1724.
25. Munaf[ograve], M.R. et al. (2017). A manifesto for reproducible
science. Nature Human Behaviour 1(0021). Available at https://doi.org/10.1038/s41562-016-0021.
26. NAS (National Academies of Sciences, Engineering, and Medicine).
(2016). Principles and obstacles for sharing data from environmental
health research: Workshop summary. Washington, DC: The National
Academies Press. Available at https://doi.org/10.17226/21703.
27. U.S. EPA's Science Advisory Board. (2020). Science Advisory
Board Consideration of the Scientific and Technical Basis of EPA's
Proposed Rule Titled ``Strengthening Transparency in Regulatory
Science.'' EPA-SAB-20-005. Available at https://yosemite.epa.gov/
sab/sabproduct.nsf/LookupWebProjectsCurrentBOARD/
2DB3986BB8390B308525855800630FCB/$File/EPA-SAB-20-005.pdf.
28. Alsheikh-Ali, A.A., Qureshi, W., Al-Mallah, M.H., and Ioannidis,
J.P. (2011). Public availability of published research data in high-
impact journals. PloS ONE 6, e24357. Available at https://doi.org/10.1371/journal.pone.0024357.
29. Iqbal, S.A., Wallach, J.D., Khoury, M.J., Schully, S.D., and
Ioannidis, J.P. (2016). Reproducible research practices and
transparency across the biomedical literature. PLoS Biol. 14,
e1002333. Available at https://doi.org/10.1371/journal.pbio.1002333.
30. Peterson, E.D. and Rockhold, F.W. (2018). Finding means to
fulfill the societal and academic imperative for open data access
and sharing. JAMA Cardiology. Available at https://doi.org/10.1001/jamacardio.2018.0129.
31. Wicherts, J.M., Borsboom, D., Kats, J. and Molenaar, D. (2006).
The poor availability of psychological research data for reanalysis.
Am. Psychol. 61, 726-728. Available at https://doi.org/10.1037/0003-066x.61.7.726.
32. Christensen, G., Dafoe, A., Miguel, E., Moore, D.A., and Rose,
A.K. (2019). A study of the impact of data sharing on article
citations using journal policies as a natural experiment. PLoS ONE
14(12): e0225883. Available at https://doi.org/10.1371/journal.pone.0225883.
33. Vasilevsky, N.A. et al. (2017). Reproducible and reusable
research: Are journal data sharing policies meeting the mark? PeerJ
5:e3208. Available at https://doi.org/10.7717/peerj.3208.
34. Stodden V., Seiler J., and Ma Z. (2018). An empirical analysis
of journal policy effectiveness for computational reproducibility.
PNAS 115(11): 2584-2589. Available at https://doi.org/10.1073/pnas.1708290115.
35. U.S. EPA. (2002). Guidelines for Ensuring and Maximizing the
Quality, Objectivity, Utility, and Integrity of Information
Disseminated by the Environmental Protection Agency. (EPA/260R-02-
008). Washington, DC: U.S. Environmental Protection Agency.
Available at https://www.epa.gov/sites/production/files/2020-02/documents/epa-info-quality-guidelines_pdf_version.pdf.
36. U.S. EPA. (2014). Framework for Human Health Risk Assessment to
Inform Decision Making. (EPA/100/R-14/001). Washington, DC: U.S.
Environmental Protection Agency, Office of the Science Advisor, Risk
Assessment Forum. Available at https://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf.
37. U.S. EPA. (2003). A Summary of General Assessment Factors for
Evaluating the Quality of Scientific and Technical Information. (EPA
100/B-03/001). Washington, DC: U.S. Environmental Protection Agency.
Available at https://www.epa.gov/sites/production/files/2015-01/documents/assess2.pdf.
38. Lewandowsky, S. and Oberauer, K. (2020). Low replicability can
support robust and efficient science. Nat Commun 11, 358. https://doi.org/10.1038/s41467-019-14203-0.
39. Mueller-Langer, F., Fecher, B., Harhoff, D., and Wagner, G.G.
(2019). Replication studies in economics--How many and which papers
are chosen for replication, and why? Research Policy 48: 62-83.
Available at https://doi.org/10.1016/j.respol.2018.07.019.

40. Field, S.M. et al. (2019). When and Why to Replicate: As Easy as
1, 2, 3? Collabra: Psychology, 5(1): 46. Available at https://doi.org/10.1525/collabra.218.
41. Hardwicke, T., Tessler, M., Peloquin, B., and Frank, M. (2018).
A Bayesian decision-making framework for replication. Behavioral and
Brain Sciences, 41, E132. Available at https://doi.org/10.1017/s0140525x18000675.
42. U.S. EPA. (2020). Freedom of Information Act Annual Report
Fiscal Year 2019. Washington, DC: U.S. Environmental Protection
Agency. Available at https://www.epa.gov/foia/epa-foia-annual-report-2019.
43. FDA (Food and Drug Administration). (2011). Advancing Regulatory
Science at FDA. Available at https://www.fda.gov/science-research/advancing-regulatory-science/strategic-plan-regulatory-science.
44. U.S. EPA. (2015). Peer Review Handbook, 4th Edition. (EPA/100/B-
15/001). Washington, DC: U.S. Environmental Protection Agency.
Available at https://www.epa.gov/sites/production/files/2020-08/documents/epa_peer_review_handbook_4th_edition.pdf.

V. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review. Any changes
made in response to OMB recommendations have been documented in the
docket. The EPA does not anticipate that this rulemaking will have an
economic impact on regulated entities.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not subject to Executive Order 13771 because this
final rule is a rulemaking of agency organization, procedure, or
practice.

C. Paperwork Reduction Act (PRA)

    This action does not contain any information collection activities
and therefore does not impose an information collection burden under
the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
does not regulate any entity outside the Federal Government.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' within the
meaning of Executive Order 13211. It is not likely to have a
significant adverse effect on the supply, distribution or use of
energy, and it has not otherwise been designated as a significant
energy action by the Administrator of the Office of Information and
Regulatory Affairs (OIRA).

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard.

L. Congressional Review Act (CRA)

    This rule is exempt from the CRA because it is a rule of agency
organization, procedure or practice that does not substantially affect
the rights or obligations of non-agency parties.

List of Subjects in 40 CFR Part 30

    Environmental protection, Administrative practice and procedure,
Reporting and recordkeeping requirements.

Andrew Wheeler,
Administrator.

0
For the reasons set forth in the preamble, the EPA is adding 40 CFR
part 30 to read as follows:

PART 30--TRANSPARENCY IN SIGNIFICANT REGULATORY ACTIONS AND
INFLUENTIAL SCIENTIFIC INFORMATION

Sec.
30.1 What is the purpose of this part?
30.2 What definitions apply to this part?
30.3 How do the provisions of this part apply?
30.4 What requirements apply to the EPA's use of studies in
significant regulatory actions?
30.5 What requirements apply to the EPA's use of dose-response data
underlying pivotal science?
30.6 What role does independent peer review have in this part?
30.7 May the EPA Administrator grant exemptions to this part?

    Authority: 5 U.S.C. App.; Pub. L. 98-80, 84 Stat. 2086.

Sec.  30.1  What is the purpose of this part?

    This part directs the EPA to give greater consideration to pivotal
science when the underlying dose-response data are available in a
manner sufficient for independent validation.

Sec.  30.2  What definitions apply to this part?

    For the purposes of this part:
    Data means the set of recorded factual material commonly accepted
in the scientific community as necessary to validate research findings
in which obvious errors, such as keystroke or coding errors, have been
removed and that is capable of being analyzed by either the original
researcher or an independent party.

    Dose-response data means the data used to characterize the
quantitative relationship between the amount of dose or exposure to a
pollutant, contaminant, or substance and an effect.
    Independent validation means the reanalysis of study dose-response
data by subject matter experts who have not contributed to the
development of the study to evaluate whether results similar to those
reported in the study are produced.
    Influential scientific information means scientific information the
Agency reasonably can determine will have or does have a clear and
substantial impact on important public policies or private sector
decisions.
    Pivotal science means the specific dose-response studies or
analyses that drive the requirements or quantitative analyses of EPA
significant regulatory actions or influential scientific information.
    Publicly available means lawfully available to the general public
from Federal, state, or local government records; the internet; widely
distributed media; or disclosures to the general public that are
required to be made by Federal, state, or local law. The public must be
able to access the information on the date of publication of the
proposed rule (or, as appropriate, a supplemental notice of proposed
rulemaking, or notice of availability) for the significant regulatory
action or on the date of dissemination of the draft influential
scientific information for public review and comment.
    Reanalyze means to analyze exactly the same dose-response data to
determine whether a similar result emerges from the analysis by using
the same methods, statistical software, models, or statistical
methodologies that were used to analyze the dose-response data, as well
as to assess potential analytical errors and variability in the
underlying assumptions of the original analysis.
    Science that serves as the basis for informing a significant
regulatory action means studies, analyses, models, and assessments of a
body of evidence that provide the basis for EPA significant regulatory
actions.
    Significant regulatory actions means final regulations determined
to be ``significant regulatory actions'' by the Office of Management
and Budget pursuant to Executive Order 12866.

Sec.  30.3  How do the provisions of this part apply?

    (a) The provisions of this part apply to science that serves as the
basis for informing a significant regulatory action or influential
scientific information, as well as to dose-response data underlying
pivotal science, regardless of the source of funding or identity of the
party conducting the science. The provisions of this part apply to
significant regulatory actions for which a proposed rule was published
in the Federal Register after January 6, 2021 and influential
scientific information submitted for peer review after January 6, 2021.
    (b) The provisions of this part do not apply to physical objects
(like laboratory samples), drafts, and preliminary analyses, and
influential scientific information or pivotal science that meet one or
more of the exemptions identified in Section IX of the OMB Final
Information Quality Bulletin for Peer Review. In the event the
procedures outlined in this part conflict with statutes the EPA
administers, or their implementing regulations, the statutes and
regulations will control. Except where explicitly stated otherwise, the
provisions of this part do not apply to any other type of Agency
action, including individual party adjudications, enforcement
activities, site-specific actions, or permit proceedings.

Sec.  30.4  What requirements apply to the EPA's use of studies in
significant regulatory actions?

    The EPA shall clearly identify the science that serves as the basis
for informing a significant regulatory action. The EPA shall make all
such science that serves as the basis for informing a significant
regulatory action publicly available to the extent permitted by law.

Sec.  30.5  What requirements apply to the EPA's use of dose-response
data underlying pivotal science?

    (a) When promulgating a significant regulatory action or developing
influential scientific information that relies on dose-response data,
the Agency shall follow best practices to evaluate potential links
between exposure to a pollutant, contaminant, or substance and the
effect and the nature of the dose-response relationship.
    (b) The EPA will use the following factors to assess the quality of
studies identified in the systematic review: soundness, applicability
and utility, clarity and completeness, uncertainty and variability, and
evaluation and review. The EPA will rely on the highest quality, most
relevant studies in determining the potential for hazard due to
exposure to a pollutant, contaminant, or substance. Where there is
convincing and well-substantiated evidence of a relationship between
exposure and effect, the EPA will identify those studies based on the
exposure situation being addressed, the quality of the studies, the
reporting adequacy, and the relevance of the endpoints that would
inform a dose-response assessment for those effect endpoints. From the
subset in the preceding sentence, the specific dose-response studies or
analyses that drive the requirements, quantitative analyses, or both of
an EPA significant regulatory action or influential scientific
information will be identified as pivotal science.
    (c) The EPA shall give greater consideration to pivotal science
where the underlying dose-response data are publicly available in a
manner sufficient for independent validation. The Agency shall also
give greater consideration to pivotal science based on dose-response
data that include confidential business information, proprietary
information or personally identifiable information if these data are
available through restricted access in a manner sufficient for
independent validation. For pivotal science where there is no access to
dose-response data, or access is limited, the Agency may still consider
these studies but will give them lesser consideration unless the
Administrator grants an exemption under Sec.  30.7. The Agency will
identify the pivotal science that was given lesser consideration and
provide a short description of why lesser consideration was given.
    (d) In determining the degree of consideration to afford pivotal
science for which the dose-response data are not available for
independent validation, the EPA shall consider the following factors
and any other relevant factors, as applicable:
    (1) The quality of the study relative to other studies for which
the dose-response data are available;
    (2) The extent to which there are other studies for which the dose-
response data are available;
    (3) The sensitivity of the conclusions in the significant
regulatory action or influential scientific information based on the
use of the study;
    (4) The extent to which the study is fit for the purpose or
intended use relative to other pivotal science for which the dose-
response data are available;
    (5) The use of exposures or doses in a range and duration that is
relevant for the intended use and that minimizes the need for
extrapolations;
    (6) The extent to which the study is supported by other scientific
evidence;
    (7) The extent to which the study accounted for unique scientific
considerations;

    (8) The extent to which the study minimizes the use of defaults and
assumptions, uses appropriate and strong statistical methods, and
includes a robust representation of uncertainty and confidence
intervals; and
    (9) The study's consideration of a broad range of parametric dose-
response or concentration-response models, a robust set of potential
confounding variables, nonparametric models that incorporate fewer
assumptions, various threshold models across the dose or exposure
range, and models that investigate factors that might account for
spatial heterogeneity.
    (e) The EPA shall also describe critical assumptions and methods
used in its dose-response assessment and shall characterize the
variability and uncertainty of the assessment. The EPA shall evaluate
the appropriateness of using default assumptions on a case-by-case
basis. The EPA shall clearly explain the scientific basis for critical
assumptions used in the dose-response assessment that the EPA relied on
for the significant regulatory action or influential scientific
information.
    (f) Where the Agency is making dose-response data publicly
available, it shall do so in a fashion that is consistent with law,
protects privacy, confidentiality, confidential business information,
and is sensitive to national security. Dose-response data is considered
``publicly available in a manner sufficient for independent
validation'' when it includes the information necessary for the public
to understand, assess, and reanalyze findings and may include, for
example:
    (1) Data (data would be made available subject to access and use
restrictions);
    (2) Associated protocols necessary to understand, assess, and
extend conclusions;
    (3) Computer codes and models involved in the creation and analysis
of such information;
    (4) Recorded factual materials; and
    (5) Detailed descriptions of how to access and use such
information.
    (g) The provisions of this section apply to dose-response data
underlying studies that are pivotal science, regardless of who funded
or conducted the studies. The Agency shall make all reasonable efforts
to explore methodologies, technologies, and institutional arrangements
for making such data available before it concludes that doing so in a
manner consistent with law and protection of privacy, confidentiality,
national security is not possible.

Sec.  30.6  What role does independent peer review have in this part?

    The EPA shall conduct independent peer review consistent with the
requirements of the OMB Final Information Quality Bulletin for Peer
Review and the exemptions described therein. The EPA will evaluate
whether or not to conduct additional peer review of individual studies
identified as pivotal science if the studies have already undergone
journal peer review. Because transparency in pivotal science includes
addressing issues associated with assumptions used in analyzing dose-
response data, the EPA shall ask peer reviewers to articulate the
strengths and weaknesses of the justification for the assumptions
applied and the implications of those assumptions for the results.

Sec.  30.7  May the EPA Administrator grant exemptions to this part?

    (a) The Administrator may grant an exemption to this part for a
study on a case-by-case basis if he or she determines that greater
consideration is warranted because:
    (1) Technological or other barriers render sharing of the dose-
response data infeasible;
    (2) The development of the dose-response data was completed or
updated before January 6, 2021;
    (3) Making the dose-response data available would conflict with
laws and regulations governing privacy, confidentiality, confidential
business information, or national security;
    (4) A third-party has conducted independent validation of the
study's underlying dose-response data through reanalysis; or
    (5) The factors used in determining the consideration to afford to
the pivotal science indicate full consideration is justified.
    (b) When making a decision to grant an exemption, the Administrator
may consider input from EPA staff and public commenters. The EPA shall
document the rationale for exemptions granted by the Administrator in
the significant regulatory action or influential scientific
information.

[FR Doc. 2020-29179 Filed 1-5-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10066-10067]
[FR Doc No: 2019-05151]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0467; FRL-9990-70-ORD]

Board of Scientific Counselors (BOSC) Safe and Sustainable Water;
Resources Subcommittee Meeting--April 2019

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act the U.S.
Environmental Protection Agency, Office of Research and Development
(ORD), gives notice of a meeting of the Board of Scientific Counselors
(BOSC) Safe and Sustainable Water Resources Subcommittee.

DATES: The meeting will be held on Tuesday, April 23, 2019, from 9:00
a.m. to 5:00 p.m., and Wednesday, April 24, 2019, from 9:00 a.m. until
3:00 p.m. All times noted are Eastern Time and approximate. The meeting
may adjourn early if all business is finished. Attendees should
register by April 16, 2019 at https://www.eventbrite.com/e/us-epa-bosc-safe-and-sustainable-water-resources-subcommittee-meeting-tickets-56588267030. Requests for making oral presentations at the meeting will
be accepted up to one business day before the meeting.

ADDRESSES: The meeting will be held at the EPA's Federal Triangle
Campus Facility, 1201 Constitution Ave. NW, Washington, District of
Columbia 20460.
    Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0467 by one
of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.

     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0467.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0467.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Chemical Safety for Sustainability Subcommittee
Docket, Mail Code: 2822T, 1301 Constitution Ave. NW, Washington, DC,
20004, Attention Docket ID No. EPA-HQ-ORD-2015-0467.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW, Washington, DC, Attention Docket ID No. EPA-
HQ-ORD-2015-0467. Note: this is not a mailing address. Deliveries are
only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: The EPA's policy is that all comments received will
be included in the public docket without change and may be made
available online at www.regulations.gov including any personal
information provided unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov website is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about the EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Board of Scientific
Counselors (BOSC) Safe and Sustainable Water Resources Subcommittee
Docket, EPA/DC, William Jefferson Clinton West Building, Room 3334,
1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the ORD Docket is (202)
566-1752.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Tom Tracy, Mail Code 8104R, Office of Science Policy, Office
of Research and Development, U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; via phone/voice mail at:
(202) 564-6518; via fax at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    General Information: The meeting is open to the public. Any member
of the public interested in receiving a draft agenda, attending the
meeting, or making a presentation at the meeting may contact Tom Tracy,
the Designated Federal Officer, via any of the contact methods listed
in the FOR FURTHER INFORMATION CONTACT section above. Individuals
making an oral presentation will be limited to a total of three
minutes. For security purposes, all attendees must provide their names
to the Designated Federal Officer by registering online at https://www.eventbrite.com/e/us-epa-bosc-safe-and-sustainable-water-resources-subcommittee-meeting-tickets-56588267030 by April 16, 2019, and must go
through a metal detector, sign in with the security desk, and show REAL
ID Act-compliant government-issued photo identification to enter the
building. Attendees are encouraged to arrive at least 15 minutes prior
to the start of the meeting to allow sufficient time for security
screening. Proposed agenda items for the meeting include but are not
limited to the following: Overview of materials provided to the
subcommittee, update on ORD's Safe and Sustainable Water Resources
Research Programs, draft Strategic Research Action Plans, review of
charge questions, and subcommittee discussion.
    Information on Services for Individuals With Disabilities: For
information on access or services for individuals with disabilities,
please contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>To
request accommodation of a disability, please contact Tom Tracy,
preferably at least ten days prior to the meeting, to give the EPA as
much time as possible to process your request.

    Dated: February 28, 2019.
Fred S. Hauchman,
Director, Office of Science Policy.
[FR Doc. 2019-05151 Filed 3-18-19; 8:45 am]
BILLING CODE 6560-50-P