[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23688-23689]
[FR Doc No: 2018-10927]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1820]

Framework for Assessing pH-Dependent Drug-Drug Interactions;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to assist with the development of a policy or guidance
document on the assessment of pH-dependent drug-drug interactions
(DDIs). In October 2017, FDA published two draft guidance documents on
DDIs entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug
Interaction Studies'' (In Vitro Studies Draft Guidance) and ``Clinical
Drug Interaction Studies--Study Design, Data Analysis, and Clinical
Implications'' (Clinical Drug Interaction Studies Draft Guidance).
These two draft guidances focus on enzyme- and transporter-based DDIs
and do not include a framework to assess pH-dependent DDIs. FDA is
seeking public input on best practices in the planning and evaluation
of pH-dependent DDIs.

DATES: Submit either electronic or written comments on this notice by
July 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 23, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-1820 for ``Framework for Assessing pH-dependent Drug-Drug
Interactions; Establishment of Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts

and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Xinning Yang, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-7412, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is establishing a public docket to assist with the development
of a policy or guidance document on the assessment of pH-dependent
DDIs. In October 2017, FDA published the In Vitro Studies draft
guidance and the Clinical Drug Interaction Studies draft guidance
(Refs. 1 and 2). These draft guidance documents assist drug developers
in the planning and evaluation of DDI studies during drug development.
These draft guidance documents also focus on enzyme- and transporter-
based DDIs but do not include a framework for assessing DDIs caused by
drug-induced changes in gastric pH.
    Acid-reducing agents (ARAs) such as antacids, histamine
H2-receptor antagonists (H2 blockers), and proton
pump inhibitors (PPIs) are widely used, and many of these products are
available over the counter (Refs. 3 and 4). For a drug whose solubility
is pH-dependent, concomitant administration with an ARA may affect its
absorption and systemic exposure, potentially resulting in loss of
efficacy or, in some cases, increased toxicity. Therefore, it is
important to assess a drug's susceptibility to pH-dependent DDIs during
drug development, characterize the DDI effect with clinical studies
when needed, and communicate study results in the drug labeling (Ref.
4). FDA is seeking public input to inform a framework to assess pH-
dependent DDIs.

II. Request for Information and Comments

    Interested persons are invited to provide detailed information and
comments on approaches to assess pH-dependent DDIs. You may also submit
information and comments in a confidential manner (see Instructions in
the ADDRESSES section). FDA is particularly interested in responses to
the following overarching questions:
    1. What are the characteristics of drugs that are susceptible to
pH-dependent DDIs? Can a stepwise approach be applied to evaluate the
interaction potential? Please provide the rationale for your
suggestions.
    2. When conducting pH-dependent DDI assessments:
    a. What are the utilities and limitations of different approaches
to evaluating DDIs (e.g., in silico, in vitro, and dedicated clinical
studies, as well as population pharmacokinetic analyses)?
    b. What are the study design considerations (e.g., study
population, choice of ARAs, dosing regimen and administration, and
pharmacokinetic sampling) for the in vivo assessments discussed in 2a
above? Please describe the rationale for any design considerations
proposed.
    c. Can we extrapolate the findings from a clinical DDI study with
one ARA drug (a PPI, H2 blocker, or antacid) to anticipate
the DDI potential for other ARAs in the same class or in a different
class? Please provide the rationale for your proposal.
    FDA will consider all information and comments submitted in a
timely manner (see ADDRESSES).

III. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA Draft Guidance for Industry, ``In Vitro Metabolism- and
Transporter-Mediated Drug-Drug Interaction Studies,'' October 2017.
Available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM581965.pdf.
2. FDA Draft Guidance for Industry, ``Clinical Drug Interaction
Studies--Study Design, Data Analysis, and Clinical Implications,''
October 2017. Available at https://www.fda.gov/downloads/drugs/guidances/ucm292362.pdf.
3. Centers for Disease Control and Prevention's (CDC's) National
Health and Nutrition Examination Survey. Available at https://www.cdc.gov/nchs/data/hus/hus16.pdf#079 (accessed May 16, 2018).
4. Zhang, L., F. Wu, S.C. Lee, et al., ``pH-Dependent Drug-Drug
Interactions for Weak Base Drugs: Potential Implications for New
Drug Development,'' Clinical Pharmacology and Therapeutics,
96(2):266-277, 2014.

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10927 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58211-58212]
[FR Doc No: 2012-23122]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2001-10948]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated July 23, 2012, Central Montana Rail, Inc. (CMR) has petitioned
the Federal Railroad Administration (FRA) for an extension of its
waiver of compliance from a provision of the Federal hours of service
laws contained at 49 U.S.C. 21103(a), as provided by 49 U.S.C.
21102(b). FRA assigned the petition Docket Number FRA-2001-10948.
    In their petition, CMR seeks relief from 49 U.S.C. 21103(a)(2),
which prohibits a train employee from remaining or going on duty for a
period in excess of 12 consecutive hours. Title 49 U.S.C. 21102(b)
allows railroads with 15 or fewer employees to petition for exemption
from the restriction outlined at 49 U.S.C. 21103(a)(2), but the
exemption may not authorize a carrier to require or allow its employees
to be on duty more than a total of 16 hours in a 24-hour period. In
support of its request, CMR explained that the allowance for train
crews to accumulate up to 16 hours of time on duty has not impacted
safety negatively, and that this allowance is only used occasionally.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.

    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 5, 2012 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78,) or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on September 12, 2012.
Ron Hynes,
Director, Office of Safety Assurance and Compliance.
[FR Doc. 2012-23122 Filed 9-18-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Rules and Regulations]
[Page 73626-73631]
[DOCID:fr28de07-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0116; FRL-8342-7]

Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
dimethenamid in or on hop, dried cones; pumpkin, radish (roots and
tops); rutabaga (roots and tops); turnip greens; turnip (roots and
tops); and winter squash. The

Interregional Research Project No. 4 (IR-4) requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation
also modifies 40 CFR 180.464, section (b) by deleting the existing
time-limited tolerance for winter squash as a permanent tolerance is
being established by this action.

DATES: This regulation is effective December 28, 2007. Objections and
requests for hearings must be received on or before February 26, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0116. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0116 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before February 26, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0116, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E7152) by IR-4. The petition requested that 40 CFR 180.464 be amended
by establishing a tolerance for residues of the herbicide dimethenamid,
1 (R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide) in or on hop, dried cones at 0.05 parts per million
(ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at
0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm;
turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at
0.1 ppm; and winter squash at 0.01 ppm. That notice referenced a
summary of the petition prepared by BASF Corporation, the registrant,
which is available to the public in the docket, http://www.regulations.gov.
 There were no comments received in response to the

notice of filing.
    Based upon review of the data supporting the petition, EPA has
approved regionally restricted tolerances for pumpkin and winter

squash for States of Oregon and Washington only, in that supporting
data are limited to EPA growing Region 12. The reason for these changes
is further explained in the supporting document for this action,
entitled, ``Dimethenamid-P. Petition for Registration for Uses Turnips
and Hops. Summary of Analytical Chemistry and Residue Data. Petition
6E7152,'' in docket ID number EPA-HQ-OPP-2007-0116.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerance for residues of dimethenamid on hop, dried cones at 0.05 ppm;
pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01
ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip,
greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm;
and winter squash at 0.01 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered the
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by dimethenamid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is available in the docket

established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0116 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for dimethenamid used for
human risk assessment can be found at http://www.regulations.gov in

document, ``Dimethenamid-P. Amended Human Health Risk Assessment for a
Proposal for the Establishment of Tolerances for Dimethenamid-P Use on
Winter Squash, Pumpkin, Radish (Roots and Tops), Rutabaga (Roots and
Tops), Turnip (Roots, Tops and Greens) and on Hops, Dried Cones,'' at
docket ID number EPA-HQ-OPP-2007-0116.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethenamid tolerances in (40
CFR 180.464). EPA assessed dietary exposures from dimethenamid in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used Dietary Exposure
Evaluation Model/Food Consumption Intake Database (DEEM/FCID) Version
2.03 which incorporates food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). An
appropriate acute endpoint attributable to a single dose was selected
for the population subgroup females 13-49. The acute dietary analysis
was conducted for dimethenamid assuming tolerance level residues,
default processing factors, and 100% crop treated (CT) information.
    ii. Chronic exposure. In conducting the chronic dietary exposure
(food and drinking water assessment), EPA used consumption data from
the USDA 1994-1996 and 1998 Nationwide CSFII. The chronic dietary
exposure assessment was conducted for dimethenamid assuming tolerance
level residues, default processing factors, and 100%CT information.
    iii. Cancer. Dimethenamid is a category ``C'' possible human
carcinogen. The chronic reference dose (cRfD) of 0.05 milligram/
kilogram/day (mg/kg/day) used for risk assessment is based on non-
cancer precursor effects in the liver; therefore, the cRfD is
considered protective of both cancer and non-cancer effects. A separate
cancer exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure

analysis and risk assessment for dimethenamid in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of dimethenamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the EPA's Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated drinking water concentrations
(EDWCs) of dimethenamid for acute exposures are estimated to be 66.7
parts per billion (ppb) for surface water and 1.0 ppb for ground water.
The EDWCs for chronic exposures are estimated to be 20.2 ppb for
surface water and 1.0 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The EDWCs for use sites with
the highest values were used. For acute dietary risk assessment, the
water concentration value of 66.7 ppb was used to assess the
contribution to drinking water. For chronic dietary risk assessment,
the water concentration of value 20.2 ppb was used to assess the
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Dimethenamid is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethenamid and any other
substances and dimethenamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethenamid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no concern for
increased qualitative and/or quantitative susceptibility following
prenatal and postnatal exposure to dimethenamid in rats and rabbits. In
the developmental toxicity study in rats there was an increased
incidence of post-implantation loss and minor skeletal variations. In
the developmental toxicity study in rabbits, late resorptions and minor
skeletal variations were observed at the highest dose tested. In the
rabbit, the developmental effects occurred at the same dose as maternal
toxicity; whereas in the rat, the developmental effects occurred at
much higher doses than in the dams. The reproduction study showed
decreases in body weight in both pups and parental animals at the same
dose levels.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for dimethenamid is complete.
    ii. There is no indication that dimethenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that dimethenamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100%CT and tolerance-level residues which results in very high-end
estimates of dietary exposure. The dietary drinking water assessment
utilizes values generated by modeland associated modeling parameters
which are designed to provide health protective, high-end estimates of
water concentrations. These assessments will not underestimate the
exposure and risks posed by dimethenamid.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to dimethenamid will occupy < 1 % of the aPAD at the 95th percentile for
females 13-49 years old, the population group of concern for acute
dimethenamid exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethenamid from food and water will utilize 3% of the cPAD for all
infants (< 1 year old), the subpopulation group with greatest exposure.
There are no residential uses for dimethenamid that result in chronic
residential exposure to dimethenamid.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Dimethenamid is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern
(LOC). A

short-term aggregate risk assessment is not required.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Dimethenamid is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern. An intermediate-term aggregate risk assessment is not
required.
    5. Aggregate cancer risk for U.S. population. The chronic reference
dose (cRfD) of 0.05 mg/kg/day used for risk assessment is based on non-
cancer precursor effects in the liver; therefore, the cRfD and chronic
risk assessment are considered protective of both cancer and non-cancer
effects.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to dimethenamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with a
nitrogen phosphorus detector (GC/NPD) Method AM-0884-0193-1) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican
maximum residue limits (MRLs) for dimethenamid on any of the crops/
commodities being proposed in this petition.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
dimethenamid, 1 (R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-
dimethylthien-3-yl)-acetamide) in or on hop, dried cones at 0.05 parts
per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm;
radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops
at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm;
turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. The existing
time-limited tolerance for winter squash shall be deleted as a
permanent tolerance is being established by this action.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.464 is amended by alphabetically adding the following
commodities to the table in paragraph (a), removing the text in
paragraph (b), and reserving it, and adding text to paragraph (c) to
read as follows:

Sec.  180.464  Dimethenamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones...........................................         0.05
                                * * * * *
Radish, roots..............................................         0.01
Radish, tops...............................................         0.01

Rutabaga, roots............................................         0.01
Rutabaga, tops.............................................          0.1
                                * * * * *
Turnip, greens.............................................          0.1
Turnip, roots..............................................         0.01
Turnip, tops...............................................          0.1
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with
regional registration are established for residues of dimethenamid, 1
(R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Pumpkin....................................................         0.01
Squash, winter.............................................         0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-25090 Filed 12-27-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Rules and Regulations]
[Page 6347-6350]
[DOCID:fr08fe06-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[Docket No. OAR-2005-0154; FRL-8028-8]

Final Rule Making Findings of Failure To Submit Required State
Implementation Plans for Phase II of the NOX SIP Call

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is taking final action making findings, under the
Clean Air Act (CAA), that Indiana, Illinois, Kentucky, Michigan, and
Virginia failed to make complete State implementation plan (SIP)
submittals required under the CAA. Under the CAA and Phase II of EPA's
nitrogen oxides (NOX) SIP Call regulations, these States
were required to submit SIP measures providing for reductions in the
emissions of NOX, an ozone precursor.

DATES: Effective Date: This final rule is effective on March 10, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-OAR-2005-0514. All documents in the docket are listed on the
http://www.regulations.gov Web site. 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, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are

available either electronically through http://www.regulations.gov or

in hard copy at the Air Docket, EPA/DC, EPA West, Room B102, 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 holidays.
The telephone number for the public reading room is<PHONE_NUMBER>, and
the Air Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: General questions concerning this
notice should be addressed to Jan King, Office of Air Quality Planning
and Standards, Air Quality Strategies and Standards Division, C539-02,
Research Triangle Park, NC 27711; telephone number<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>Legal questions should
be addressed to Winifred Okoye, Office of General Counsel, (2344A),
1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number:
(202) 564-5446; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Outline

I. Background
II. What Action Is EPA Taking Today?
III. Statutory and Executive Order Reviews
    A. Notice and Comment Under the Administrative Procedures Act
    B. Executive Order 12866: Regulatory Planning and Review
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    I. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    J. National Technology Transfer Advancement Act
    K. Congressional Review Act

I. Background

    On October 27, 1998 (63 FR 57356), we took final action in the
NOX SIP Call Rule, under sections 110(a)(2)(D) and 110(k)(5)
of the CAA, to prohibit specified amounts of emissions of one of the
main precursors of ground-level ozone, NOX, in order to
reduce ozone transport across State boundaries in the eastern half of
the United States. Based on extensive air quality modeling and
analyses, we found that sources in 22 States and the District of
Columbia (DC) (23 States) emit NOX in amounts that
significantly contribute to nonattainment of both the 1-hour and 8-hour
ozone national ambient air quality standards (NAAQS) in downwind
States. We set forth requirements for each of the affected upwind
States to submit SIP revisions prohibiting those amounts of
NOX emissions which significantly contribute to downwind air
quality problems. In the NOX SIP Call Rule, as modified by
the March 2, 2000, technical amendments (65 FR 11222), we also
established statewide NOX emissions budgets for the affected
States. The budgets were calculated by assuming the emissions
reductions that would be achieved by applying available, highly cost-
effective controls to source categories of NOX emissions.
States had the flexibility to adopt the appropriate mix of controls to
meet their statewide NOX emissions budgets.
    A number of parties, including certain States as well as industry
and labor groups, challenged our NOX SIP Call Rule by filing
petitions for review in the U.S. Court of Appeals for the District of
Columbia (DC Circuit or Court). On March 3, 2000, the DC Circuit issued
an opinion, largely upholding the 1-hour basis for the NOX
SIP Call.\1\
---------------------------------------------------------------------------

    \1\ In light of various legal challenges to our promulgation of
the 8-hour ozone NAAQS (62 FR 38856; July 18, 1997), we requested,
and the Court granted our motion to stay consideration of issues
regarding the 8-hour basis for the NOX SIP Call.
Additionally, on September 18, 2000, we stayed the 8-hour basis for
the NOX SIP Call indefinitely. (65 FR 56245). See also 40
CFR 51.121(q).
---------------------------------------------------------------------------

    In response to the Court decision, EPA divided the NOX
SIP Call Rule into two phases, now known as Phase I and Phase II. Under
Phase I of the rule, EPA moved ahead with implementing those aspects of
the rule that were upheld by the Court for 19 States and the District
of Columbia. The EPA required these States to submit SIPs that comply
with Phase I by October 30, 2000. Because the Court vacated the rule as
to Wisconsin, Georgia, and Missouri, these States were not required to
submit Phase I SIPs.
    On April 21, 2004, EPA published a final response to the Court
decision that addressed the outstanding issues remanded or otherwise
vacated by the Court, and which is Phase II of the NOX SIP
Call rule. The affected States were required to submit Phase II SIPs by
April 1, 2005.\2\
---------------------------------------------------------------------------

    \2\ The States which are required to submit Phase II SIPs are
Alabama, Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri,
Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, and West
Virginia. With respect to Georgia, however, EPA has stayed this
requirement in order to respond to a petition of reconsideration
filed by the Georgia Coalition for Sound Environmental Policy. (70
FR 5159; August 31, 2005).
---------------------------------------------------------------------------

II. What Action Is EPA Taking Today?

    Today, EPA is making findings of failure to submit complete SIP
revisions, including adopted rules, in response to Phase II of the
NOX SIP Call.\3\ The States that are receiving findings of
failure to submit Phase II SIP revisions are Indiana, Illinois,
Kentucky, Michigan, and Virginia. This finding defines the start of a
clock for EPA to develop a federal implementation plan (FIP) under
section 110(c) of the CAA.
---------------------------------------------------------------------------

    \3\ Our stay of the 8-hour basis of the NOX SIP Call
Rule is with respect to all aspects of the rule as they relate to
the 8-hour requirements, thus, the affected States remain under no
obligation to submit SIP revisions that address the 8-hour basis for
the NOX SIP Call. Today's findings, therefore, are only
for purposes of the 1-hour basis, and not the 8-hour basis of the
NOX SIP Call Rule.
---------------------------------------------------------------------------

    Recently, EPA sent letters to State officials of the affected
States describing the status of the States' effort in completing a
Phase II SIP. The letters also noted that we would be publishing
findings of failure to submit in the Federal Register. (These letters
are included in the docket for this rulemaking). The EPA intends to
continue working with these States so that they can submit approvable
adopted rules as soon as possible.

III. Statutory and Executive Order Reviews

A. Notice and Comment Under the Administrative Procedures Act

    This is a final EPA action, but is not subject to notice-and-
comment requirements of the Administrative Procedures Act (APA), 5
U.S.C. 553(b). The EPA invokes, consistent with past practice (see for
example, 61 FR 36294, July 10, 1996), the good cause exception pursuant
to the APA, 5 U.S.C. 553(b)(3)(B). Notice and comment are unnecessary
because no significant EPA judgment is involved in making a finding of
failure to submit SIPs or elements of SIPs required by the CAA, where
States have made no submissions to meet the requirement by the
statutory date.

B. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and,
therefore, subject to OMB review and the requirements of the Executive
Order. The order defines ``significant regulatory action'' as one that
is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;

    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Pursuant to the terms of Executive Order 12866, a determination has
been made that this rule is not a ``significant regulatory action''
because none of the above factors apply. As such, this final action was
not formally submitted to the Office of Management and Budget (OMB) for
review.

C. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

D. Regulatory Flexibility Act

    Today's final rule is not subject to the Regulatory Flexibility Act
(RFA), which generally requires an agency to prepare a regulatory
flexibility analysis for any rule that will have a significant economic
impact on a substantial number of small entities. The RFA applies only
to rules subject to notice-and-comment rulemaking requirements under
the APA or any other statute. This rule is not subject to notice-and-
comment requirements under the APA or any other statute because
although the rule is subject to the APA, the Agency has invoked the
``good cause'' exemption under 5 U.S.C. 553(b), therefore it is not
subject to the notice and comment requirement.

E. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal Agencies to assess the
effects of their regulatory actions on State, local and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
1 year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments to have
meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small government on compliance with
regulatory requirements.
    The EPA has determined that this rule does not contain a Federal
mandate that may result in expenditures of $100 million or more in any
1 year by either State, local, or Tribal governments in the aggregate
or to the private sector in any 1 year. It does not create any
additional requirements beyond those of the NOX SIP Call (63
FR 57356). This rule responds to the requirement in the CAA for States
to submit SIPs to satisfy requirements of the NOX SIP Call.
This action simply finds that States have failed to submit SIPs to
address a pre-existing statutory requirement under the CAA. Thus,
today's rule is not subject to the requirements of sections 202 and 205
of the UMRA.

F. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, or the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule 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,
as specified in Executive Order 13132.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This final rule does not have
``Tribal implications'' as specified in Executive Order 13175. This
rule responds to the requirement in the CAA for States to submit SIPs
to satisfy certain elements required under section 110(a)(2) of the CAA
for the NOX SIP Call. Thus, Executive Order 13175 does not
apply to this rule.

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

    Executive Order 13045: ``Protection of Children From Environmental
Health and Safety Risks'' (62 FR 19885, April 23, 1997) applies to any
rule that (1) is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health and safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA.
    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because EPA does not have reason to believe that the environmental
health risks or safety risks addressed by this rule present a
disproportionate risk or safety risk to children.

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

    This rule is not subject to Executive Order 13211, ``Actions That
Significantly Affect Energy Supply, Distribution, or Use,'' (66 FR
28355, May 22, 2001) because it is not a significant regulatory action
under Executive Order 12866.

J. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act

of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impracticable. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, and business practices) that are
developed or adopted by VCS bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when EPA decides not to use
available and applicable VCS.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective March 10, 2006.

List of Subjects in 40 CFR Part 51

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Ozone, Reporting
and recordkeeping requirements.

    Dated: January 27, 2006.
William L. Wehrum,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. 06-1175 Filed 2-7-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Rules and Regulations]
[Pages 35806-35807]
[FR Doc No: 2020-11302]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2020-0228]
RIN 1625-AA00

Safety Zone; Harbor Beach Fireworks, Lake Huron, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 200-yard radius of a portion of Lake Huron,
Harbor Beach, MI. This zone is necessary to protect spectators and
vessels from potential hazards associated with the Harbor Beach
Fireworks.

DATES: This temporary final rule is effective from 10 p.m. on July 10,
2020 through 11 p.m. on July 12, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2020-0228 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Tracy Girard, Prevention Department,
Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Detroit
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
Coast Guard did not receive the final details of this fireworks display
in time to publish an NPRM. As such, it is impracticable to publish an
NPRM because we lack sufficient time to provide a reasonable comment
period and then consider those comments before issuing the rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Detroit (COTP) has determined that
potential hazard associated with fireworks from 10 p.m. on July 10,
2020 through 11 p.m. on July 12, 2020 will be a safety concern to
anyone within a 200-yard radius of the launch site. This rule is needed
to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone while the fireworks are being
displayed.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 p.m. on July 10, 2020
through 11 p.m. on July 12, 2020. The safety zone will be enforced from
10 p.m. until 11 p.m. on July 10, 2020 and July 11, 2020. In the case
of inclement weather on July 10, 2020 or July 11, 2020, this safety
zone will be enforced from 10 p.m. to 11 p.m. on July 12, 2020. The
safety zone will encompass all U.S. navigable waters of Lake Huron,
Harbor Beach, MI, within a 200-yard radius of position 43[deg]50.77' N,
082[deg]38.63' W (NAD 83). No vessel or person will be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of Lake Huron from 10 p.m. on July 10,
2020 through 11 p.m. on July 12, 2020. Moreover, the Coast Guard will
issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16
about the zone and the rule allows vessels to seek permission to enter
the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's

responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting one and a half
hours on two nights that will prohibit entry into a designated area. It
is categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0228 to read as follows:

Sec.  165.T09-0228  Safety Zone; Harbor Beach Fireworks, Lake Huron,
MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of Lake Huron, Harbor Beach, within a 200-yard radius
of position 43[deg]50.77' N, 082[deg]38.63' W (NAD 83).
    (b) Enforcement period. The regulated area described in paragraph
(a) of this section will be enforced from 10 p.m. until 11 p.m. on July
10, 2020 and July 11, 2020. In the case of inclement weather on July
10, 2020 or July 11, 2020, this safety zone will be enforced from 10
p.m. to 11 p.m. on July 12, 2020.
    (c) Regulations. (1) No vessel or person may enter, transit
through, or anchor within the safety zone unless authorized by the
Captain of the Port Detroit (COTP), or his on-scene representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or his on-scene representative.
    (3) The ``on-scene representative'' of COTP is any Coast Guard
commissioned, warrant or petty officer or a Federal, State, or local
law enforcement officer designated by or assisting the Captain of the
Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the COTP or his on-scene
representative to obtain permission to enter or operate within the
safety zone. The COTP or his on-scene representative may be contacted
via VHF Channel 16 or at<PHONE_NUMBER>. Vessel operators given
permission to enter or operate in the regulated area must comply with
all directions given to them by the COTP or his on-scene
representative.

    Dated: May 13, 2020.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2020-11302 Filed 6-11-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Page 34390]
[FR Doc No: 2014-13985]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending May 31, 2014

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.

    Docket Number: DOT-OST-2014-0085.
    Date Filed: May 27, 2014.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: June 17, 2014.
    Description: Hyperion Aviation Ltd (``Hyperion'') requesting
issuance of an exemption and a foreign air carrier permit authorizing
Hyperion to engage in: (i) Foreign charter air transportation of
persons, property and mail from any point or points behind any Member
State of the European Union, via any point or points in any EU Member
State and via intermediate points, to any point or points in the United
States and beyond; (ii) foreign charter air transportation of persons,
property and mail between any point or points in the United States and
any point or points in any member of the European Common Aviation Area;
(iii) foreign charter air transportation of cargo between any point or
points in the United States and any other point or points; (iv) other
charters pursuant to the prior approval requirements set forth in the
Department's regulations governing charters; and (v) charter
transportation authorized by any additional route rights made available
to European Union carriers in the future, to the extent permitted by
Hyperion's homeland license on file with the Department.

    Docket Number: DOT-OST-2014-0087.
    Date Filed: May 28, 2014.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: June 18, 2014.
    Description: Application of United Airlines, Inc. (``United'')
requesting an exemption, a certificate of public convenience and
necessity, and allocation of two weekly U.S.-China frequencies to
permit United to provide twice-weekly scheduled foreign air
transportation of persons, property and mail between Guam and Shanghai,
People's Republic of China.

Cheryl F. Collins,
Dockets Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2014-13985 Filed 6-13-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Page 28857]
[FR Doc No: 2018-13291]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2018-0009; OMB No. 1660--NEW]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Transcript Request Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before July 23, 2018.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
[email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address [email protected] or
Clarence (Smiley) White, Chief, Operations and Support Branch, United
States Fire Administration,<PHONE_NUMBER> or by email at
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on February 22, 2018 at 83
FR 7752 with a 60 day public comment period. FEMA received two
anonymous public comments that were not relevant to the information
collection. The purpose of this notice is to notify the public that
FEMA will submit the information collection abstracted below to the
Office of Management and Budget for review and clearance.

Collection of Information

    Title: Transcript Request Form.
    Type of Information Collection: New information collection.
    OMB Number: 1660--NEW.
    Form Titles and Numbers: FEMA Form 064-0-0-12, Transcript Request
Form.
    Abstract: FEMA provides training to advance the professional
development of personnel engaged in fire prevention and control and
emergency management activities through its Center for Domestic
Preparedness (CDP), Emergency Management Institute (EMI), National Fire
Academy (NFA), National Training and Education Division, National
Domestic Preparedness Consortium, and Rural Domestic Preparedness
Consortium. FEMA collects information from students who have completed
courses at the National Fire Academy (NFA) and the Emergency Management
Institute (EMI) for the purpose of fulfilling the student's request to
provide a copy of their transcript for their personal records and/or
for transmittal to an institution of higher education that delivers
training and education also in support of the FEMA mission.
    Affected Public: Individuals or households; Business or other for-
profit; Not-for-profit institutions; State, Local or Tribal Government.
    Estimated Number of Respondents: 4,500.
    Estimated Number of Responses: 4,500.
    Estimated Total Annual Burden Hours: 225 hours.
    Estimated Total Annual Respondent Cost: $7,978.50.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $28,899.24.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Rachel Frier,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2018-13291 Filed 6-20-18; 8:45 am]
 BILLING CODE 9111-45-P


[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 135-136]
[FR Doc No: 2021-28428]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-421, OMB Control No. 3235-0481]

Submission for OMB Review; Comment Request; Extension: Rule 15c2-
8

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in the following rule:
Rule 15c2-8 (17 CFR 240.15c2-8), under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.).
    Rule 15c2-8 requires broker-dealers to deliver preliminary and/or
final prospectuses to certain people under certain circumstances. In
connection with securities offerings generally, including initial
public offerings (``IPOs''), the rule requires broker-dealers to take
reasonable steps to distribute copies of the preliminary or final
prospectus to anyone who makes a written request, as well as any
broker-dealer who is expected to solicit purchases of the security and
who makes a request. In connection with IPOs, the rule requires a
broker-dealer to send a copy of the preliminary prospectus to any
person who is expected to receive a confirmation of sale (generally,
this means any person

who is expected to actually purchase the security in the offering) at
least 48 hours prior to the sending of such confirmation. This
requirement is sometimes referred to as the ``48 hour rule.''
    Additionally, managing underwriters are required to take reasonable
steps to ensure that all broker-dealers participating in the
distribution of or trading in the security have sufficient copies of
the preliminary or final prospectus, as requested by them, to enable
such broker-dealer to satisfy their respective prospectus delivery
obligations pursuant to Rule 15c2-8, as well as Section 5 of the
Securities Act of 1933.
    Rule 15c2-8 implicitly requires that broker-dealers collect
information, as such collection facilitates compliance with the rule.
There is no requirement to submit collected information to the
Commission. In order to comply with the rule, broker-dealers
participating in a securities offering must keep accurate records of
persons who have indicated interest in an IPO or requested a
prospectus, so that they know to whom they must send a prospectus.
    The Commission estimates that the time broker-dealers will spend
complying with the collection of information required by the rule is
24,200 hours for equity IPOs and 29,320 hours for other offerings. The
Commission estimates that the total annualized cost burden (copying and
postage costs) is $48,400,000 for IPOs and $1,172,800 for other
offerings.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) [email protected] and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John R. Pezzullo, 100 F Street NE, Washington, DC 20549, or by
sending an email to: [email protected].

    Dated: December 28, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-28428 Filed 12-30-21; 8:45 am]
BILLING CODE 8011-01-P