[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Notices]
[Page 34989-34990]
[DOCID:fr19jn08-124]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Delays in
Processing of Special Permits Applications

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Applications Delayed more than 180 days.

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SUMMARY: In accordance with the requirements of 49 U.S.C. 5117(c),
PHMSA is publishing the following list of special permit applications
that have been in process for 180 days or more. The reason(s) for delay
and the expected completion date for action on each application is
provided in association with each identified application.

FOR FURTHER INFORMATION CONTACT: Delmer F. Billings, Director, Office
of Hazardous Materials Special Permits and Approvals, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue,
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

Key to ``Reason for Delay''

    1. Awaiting additional information from applicant.
    2. Extensive public comment under review.
    3. Application is technically complex and is of significant, impact
or

precedent-setting and requires extensive analysis.
    4. Staff review delayed by other priority issues or volume of
special permit applications.

Meaning of Application Number Suffixes

    N--New application.
    M--Modification request.
    PM--Party to application with modification request.

    Issued in Washington, DC, on June 9, 2008.
Delmer F. Billings,
Director, Office of Hazardous Materials, Special Permits and Approvals.

----------------------------------------------------------------------------------------------------------------
                                                                                Reason for   Estimated date
               Application no.                             Applicant                  delay       of completion
----------------------------------------------------------------------------------------------------------------
                                         MODIFICATION TO SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
11579-M.....................................  Austin Powder Company, Cleveland,           3, 4        07-31-2008
                                               OH.
10964-M.....................................  Kidde Aerospace & Defense, Wilson,             4        06-30-2008
                                               NC.
14167-M.....................................  Trinityrail, Dallas, TX............            4        07-31-2008
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                                         NEW SPECIAL PERMIT APPLICATIONS
----------------------------------------------------------------------------------------------------------------
14566-N.....................................  Nantong CIMC Tank Equipment Co.                3        08-31-2008
                                               Ltd., Nantong City, China.
14621-N.....................................  Beijing Tianhai Industry Co., Ltd.,            4        07-31-2008
                                               Beijing.
14616-N.....................................  Chlorine Service Company, Kingwood,            3        08-31-2008
                                               TX.
14619-N.....................................  OXEA Corporation, Dallas, TX.......            4        07-31-2008
14622-N.....................................  Occidental Chemical Corporation,               4        07-31-2008
                                               Dallas, TX.
----------------------------------------------------------------------------------------------------------------

[FR Doc. E8-13530 Filed 6-18-08; 8:45 am]

BILLING CODE 4910-60-M


    I. E.I. du Pont de Nemours and Company

    PP No. 1F7840

    EPA has received a pesticide petition (PP No. 1F7840) from E.I. du Pont de Nemours & Company, 1007 Market Street, Wilmington, DE 19898, proposing pursuant to section 408 (d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a (d), to amend 40 CFR Part 180.364(a) by moving canola seed from paragraph (1) to paragraph (2).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d) (2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

    A. RESIDUE CHEMISTRY

    1. Plant Metabolism

    DuPont has investigated the behaviour of 14C-glyphosate (sesquisodium or mono potassium salts) and 14C-N-acetylglyphosate in tobacco, corn, soybean, and canola plants containing various versions of the gat gene.  Plant metabolism investigations were conducted under laboratory (excised tobacco, corn and soybean seedlings) and greenhouse (corn, soybean and canola whole plant) conditions.
    N-Acetylglyphosate was the principal metabolite formed in gat plants after treatment with [14]C-glyphosate, and is an appropriate residue to be quantified in Optimum[(R)] GLY canola. The other major plant residue observed was glyphosate.

    2. Analytical Methods

    An analytical method was developed, and validated, for the determination of glyphosate and degradate residues in transgenic crop and crop fraction matrices.  The analytes examined included glyphosate and N-acetylglyphosate, AMPA (aminomethylphosphonic acid), and N-acetyl AMPA. N-acetylglyphosate, is the principal metabolite associated with transgenic crops containing the glyphosate N-acetyltransferase (gat) enzyme.  The method target limit of quantitation (LOQ) in each matrix examined was 0.050 mg/kg (ppm).  The method was validated at 0.050 mg/kg and 0.50 mg/kg or higher fortification level using a LC/MS/MS system operating with an electrospray interface (ESI) in positive ion mode detection.  The recoveries from samples of various corn and soybean matrices fortified at 0.050 mg/kg (LOQ) and 0.50 mg/kg (10xLOQ) or higher fortification level support the satisfactory performance of this method.  Additionally, validation analyses were conducted for plum and lime matrices to support method performance in watery and acid crop matrices, even though these crop types do not contain gat enzyme and would not contain N-acetylglyphosate as a glyphosate herbicide residue.  The extraction procedure used in this method is consistent with the method developed for corn RACs in a pilot plant metabolism study using radiolabeled glyphosate and extracting incurred plant residues.  In addition, consistent residue results for glyphosate residues from field trial samples of corn forage, grain, and stover were determined using this method and a current glyphosate enforcement method.

    An analytical method was developed, and validated, for the determination of glyphosate, N-acetylglyphosate, AMPA, and N-acetyl AMPA in animal matrices including milk, eggs, muscle, kidney, liver, and fat. The method target limit of quantitation (LOQ) in glyphosate equivalents for each analyte was 0.025 mg/kg in egg, milk, and muscle matrices and 0.050 mg/kg in kidney, liver, and fat matrices. The method was validated at the respective LOQ and 10xLOQ level for each matrix using a LC/MS/MS system operating with an electrospray interface (ESI) in positive or negative ion mode detection. The recoveries from matrix samples fortified at the respective LOQ and higher levels support the satisfactory performance of this method.

    3. Magnitude of Residue in Canola

    DuPont has conducted a full set of at-harvest residue studies to determine residues of glyphosate, N-acetylglyphosate, AMPA, and N-acetyl AMPA in Optimum[(R)] GLY canola that has been treated with an herbicide containing the active ingredient glyphosate. These trials demonstrate that, when applied to Optimum[(R)] GLY canola according to a registered treatment regime, combined residues of glyphosate plus N-acetylglyphosate, the principal plant metabolite, do not exceed the relevant tolerances established for glyphosate per se.

    B. TOXICOLOGICAL PROFILE

    1. Acute Toxicity

    Data from an acute oral toxicity study conducted in laboratory animals demonstrates that N-acetylglyphosate is of low toxicity to mammals following acute exposure.  Five male and five female rats received a limit dose of 5,000 mg/kg by gavage.  One female died on the day of dosing, and one male and one female were found dead the day after dosing.  All clinical signs of toxicity were resolved in the remaining seven rats by day three.  All surviving animals gained weight from initiation of dosing to study termination.  The N-acetylglyphosate oral LD50 for both male and female rats is greater than 5,000 mg/kg body weight.

    2. Genotoxicity

    The CHO/HGPRT test was used to evaluate the test substance, N-acetylglyphosate, for its mutagenic potential in the absence and presence of an exogenous metabolic activation system (Aroclor-1254 induced rat liver S9) in Chinese hamster ovary (CHO) cells. To establish a range of doses for the mutagenesis assay, a preliminary cytotoxicity assay was conducted. Based on the findings in the preliminary study, the concentrations chosen for the mutagenesis assay were 250, 500, 1000, 1500, and 2091 μg/mL for both test conditions (-S9 and +S9). No positive responses, i.e., mutant frequencies >40 mutants per 106 clonable cells, were observed in the mutagenesis assay. No substantial toxicity, i.e., cloning efficiency <50% of the vehicle control, was observed at any dose level. No visible precipitate was observed in the treatment medium at any concentration. Under the conditions of this study N-acetylglyphosate was not found to induce forward mutations at the HGPRT gene locus of CHO cells in either the nonactivated or S9-activated test conditions. The test substance was concluded to be negative in this in vitro test.

    N-Acetylglyphosate did not cause structural chromosomal aberrations in Chinese hamster ovary (CHO) cells in an in vitro chromosome aberration assay either with or without exogenous metabolic activation.  Replicate cultures of CHO cells were treated with N-acetylglyphosate for 3 hours at doses ranging from 19.0 to 2,800 μg/mL with or without metabolic activation, and harvested approximately 20 hours after treatment initiation.  An additional set of cultures was treated for 20 hours without metabolic activation.  No significant increase in cells with chromosomal aberrations, polyploidy or endoreduplication was observed in treated cultures.

    The test substance, N-acetylglyphosate, was evaluated for its ability to induce micronuclei in bone marrow polychromatic erythrocytes (PCEs) in male and female Crl:CD1(ICR) mice. Based on range finding results, doses of 0, 500, 1000, or 2000 mg/kg of the test substance were selected for the main study. No clinical signs of toxicity or mortality were observed in the rangefinder experiment. All animals were given a single dose by oral intubation. In the main study, there were no significant changes in body weight or body weight gain in either male or female animals administered the test substance, or in the vehicle or positive control groups. No clinical signs of toxicity were observed at any dose level in test substance-treated male and female mice exposed to the test substance. No abnormalities were detected in the vehicle or positive control groups. No mortality occurred during the study. No statistically significant increases in micronucleated PCE frequency were observed in any evaluated test substance-treated group of male or female animals at either timepoint. There were no statistically significant decreases in PCEs among 1000 erythrocytes. The positive control groups exhibited a response consistent with the micronucleated PCE historical control data. Under the conditions of this study, N-acetylglyphosate did not induce statistically significant or biologically relevant increases in micronucleated polychromatic erythrocytes in animal bone marrow. The test substance was concluded to be negative in this in vivo study.

     N-Acetylglyphosate was negative in the bacterial reverse mutation (Ames) assay with and without metabolic activation.  N-Acetylglyphosate was negative for reverse mutations in Salmonella typhimurium tester strainsTA98, TA100, TA1535, and TA1537 at the histidine locus in the presence or absence of mammalian microsomal metabolic activation system.   N-Acetylglyphosate was negative for reverse mutations in E. coli tester strain WP2uvrA at the tryptophan locus in the presence or absence of mammalian microsomal metabolic activation system.

    3. Subchronic Toxicity

    A 90-day feeding study was conducted to assess the potential subchronic toxicity of N-acetylglyphosate in rats. Five groups of young adult male and female Crl:CD(SD) rats (10/sex/group) were administered diets that contained 0, 180, 900, 4500, or 18,000 ppm N-acetylglyphosate for approximately 90 days (95 days in males and 96 days in females). Samples of the diets were analyzed to assess homogeneity, stability, and concentration of the test substance in the diet. Body weights, food consumption, and detailed clinical observations were evaluated weekly. Ophthalmological and neurobehavioral (abbreviated functional observational battery, grip strength, motor activity) evaluations were performed on all rats prior to the start of dietary exposure and near the end of the exposure period. Clinical pathology endpoints (hematology, coagulation, clinical chemistry, urinalysis) were evaluated at the end of the exposure period. After approximately 90 days of dietary exposure, the surviving rats were sacrificed and given a gross and microscopic pathological examination.
    No adverse test substance-related effects on any body weight or nutritional parameters were observed. Statistically significantly lower overall mean body weight gain (86% of control) was observed in 18,000 ppm males but was not considered adverse as it was not associated with a statistically significant difference in mean final body weight, or in overall mean food consumption or food efficiency.
    No test substance-related deaths occurred, and no clinical, ophthalmological, or neurobehavioral observations were attributed to exposure to the test substance. There were no adverse effects on clinical pathology parameters, organ weights, gross pathology, or microscopic pathology in male or female rats.
    The no-observed-adverse-effect level (NOAEL) for male and female rats was 18,000 ppm, equivalent to 1157 and 1461 mg/kg/day in males and females, respectively. The NOAEL is based on a lack of adverse, test substance-related effects in either sex at 18,000 ppm, the highest concentration tested.

    4. Animal Metabolism

     The absorption, metabolism, and elimination of N-acetylglyphosate were evaluated in male rats following a single oral administration of [[14]C]N-acetylglyphosate.  N-Acetylglyphosate is incompletely absorbed from the gastrointestinal tract and rapidly eliminated in the urine and feces.  Greater than 90% of the administered dose was eliminated by 48 hours after dosing.  Approximately 66% of a dose of [[14]C]N-acetylglyphosate was absorbed following ingestion, and eliminated entirely unchanged in the urine.  Approximately 26% of the [[14]C]N-acetylglyphosate administered was eliminated in the feces, almost entirely as the parent compound.  More than 99% of the radioactivity in the feces was in the form of N-acetylglyphosate; glyphosate was the only metabolite present in the feces, comprising less than 1% of the radiolabeled dose administered.  The maximum N-acetylglyphosate concentrations in blood and plasma were reached at 1 and 2 hours post-dose, respectively.  Radioactivity in blood and plasma consisted entirely of unchanged [[14]C] N-acetylglyphosate; no metabolites were present.

     N-Acetylglyphosate ingested from glyphosate-tolerant crops is of low toxicity and will likely be rapidly eliminated from the body unchanged in the urine and feces.  The portion of N-acetylglyphosate that is absorbed is eliminated in the urine with a half-life of less than one day, the remainder is eliminated in the feces largely unchanged.  The absorption, metabolism and elimination of N-acetylglyphosate are similar to those reported in the literature for glyphosate.  Both compounds are incompletely absorbed and rapidly eliminated in the urine and feces.

    C. AGGREGATE EXPOSURE, CUMULATIVE EFFECTS, AND SAFETY DETERMINATION

    The residue trials previously described demonstrate that following the application of glyphosate to Optimum[(R)] GLY canola, combined residues of glyphosate plus N-acetylglyphosate (expressed as glyphosate per se) do not exceed tolerances currently established at 40 CFR 180.364 for canola seed. Therefore, no additional risk assessments have been conducted since N-acetylglyphosate has been shown to be toxicologically equivalent to glyphosate, and no change in the magnitude of the relevant tolerances is proposed.

    D. INTERNATIONAL TOLERANCES

    Numerous countries have established tolerances for glyphosate on canola. No tolerances have been established to date for N-acetylglyphosate in canola.


[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Pages 2429-2430]
[FR Doc No: 2021-00428]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0666]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number 1625-0040

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0040,
Applications for Merchant Mariner Credentials and Medical Certificates;
without change. Our ICR describes the information we seek to collect
from the public. Review and comments by OIRA ensure we only impose
paperwork burdens commensurate with our performance of duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
February 11, 2021.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2020-0666]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order 13771, Reducing
Regulation and Controlling Regulatory Costs, and Executive Order 13777,
Enforcing the Regulatory Reform Agenda, the Coast Guard is also
requesting comments on the extent to which this request for information
could be modified to reduce the burden on respondents. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2020-0666], and must be received by February 11,
2021.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For more about privacy and submissions to OIRA in
response to this document, see the https://www.reginfo.gov, comment-
submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each
ICR. An OMB Notice of Action on each ICR will become available via a
hyperlink in the OMB Control Number: 1625-0040.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (85 FR 66573, October 20, 2020)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Applications for Merchant Mariner Credentials and Medical
Certificates.
    OMB Control Number: 1625-0040.
    Summary: This information is necessary to determine competency,
character and physical qualifications for the issuance of a Merchant
Mariner Credential (MMC) or Medical Certificate.
    Need: Title 46 Code of Federal Regulation (CFR) parts 10-13 and 16
detail the requirements for the issuance of an MMC or Medical
Certificate.
    Forms:
     CG-719B, Application for Merchant Mariner Credential.
     CG-719C, Disclosure Statement for Narcotics, DWI/DUI, and/
or Other Convictions.
     CG-719K, Application for Medical Certificate.
     CG-719K/E, Application for Medical Certificate, Short
Form.
     CG-719P, DOT/USCG Periodic Drug Testing Form.
     CG-719S, Small Vessel Sea Service Form.
    Respondents: Applicants for MMC, whether original, renewal,
duplicate, raise of grade, or a new endorsement on a previously issued
MMC. Applicants for Medical Certificates to include National and STCW
credentialed mariners, and first-class pilots.

    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
47,444 hours to 62,004 hours a year; due to an increase in the
estimated annual number of responses..

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: January 7, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2021-00428 Filed 1-11-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22862-22864]
[FR Doc No: 2019-10359]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1533]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; National Panel of
Tobacco Consumer Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 June
19, 2019.

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:
202-395-7285, or emailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0815. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<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.

National Panel of Tobacco Consumer Studies

OMB Control Number 0910-0815--Extension

I. Background

    FDA's Center for Tobacco Products (CTP) established a national,
primarily web-based panel of about 4,000 tobacco users. The panel
includes individuals who can participate in up to eight studies over a
3-year period to assess consumers' responses to tobacco marketing,
warning statements, product labels, and other communications about
tobacco products. CTP established the panel of consumers because
currently existing panels have a number of significant limitations.
First, many existing consumer panels are drawn from convenience samples
that limit the generalizability of study findings (Ref. 1). Second,
although at least two probability-based panels of consumers exist in
the United States, there is a concern that responses to the studies
using tobacco users in these panels may be biased due to panel
conditioning effects (Refs. 2 and 3). That is, consumers in these
panels complete surveys so frequently that their responses may not
adequately represent the population as a whole. Panel conditioning has
been associated with repeated measurement on the same topic (Ref. 4),
panel tenure (Ref. 2), and frequency of the survey request (Ref. 3).
This issue is of particular concern for tobacco users who represent a
minority of the members in the panels, and so may be more likely to be
selected for participation in experiments and/or surveys related to
tobacco products. Third, a key benefit of the web panel approach is
that the surveys can include multimedia, such as images of tobacco
product packages, tobacco advertising, new and existing warning
statements and labels, and potential reduced harm claims in the form of
labels and print advertisements. Establishing a primarily web-based
panel of tobacco users through in-person probability-based recruitment
of eligible adults and limiting the number of times individuals
participate in tobacco-related studies will result in nationally
representative and unbiased data collection on matters of importance
for FDA.
    With this submission, FDA seeks an extension on the currently
approved information collection request from OMB for remaining planned
panel maintenance and replenishment activities for the National Panel
of Tobacco Consumer Studies. Data collection activities will involve
mail and in-person household screening, in-person recruitment of
tobacco users, enrollment of selected household members, and
administration of a baseline survey, following all required informed
consent procedures for panel members. Panel members will be asked to
participate in up to eight experimental and observational studies over
the 3-year panel commitment period. The first of these panel studies,
study A ``Brands and Purchasing Behavior,'' was included in the
currently approved information collection request. Approval for study B
``Coupons and Free Samples,'' study C ``Consumer Perceptions of Product
Standards,'' and study D ``Hypothetical Purchasing of Tobacco
Products'' are included in this request for extension. Study B will be
an observational study offered to all panelists that will provide a
more in-depth examination of tobacco product promotions, namely free
samples and coupons, after the ban on distribution of free samples of
tobacco products (with the exception of certain smokeless tobacco
exemptions) that went into effect when FDA finalized the ``Deeming
Rule'' on August 8, 2016 (published May 10, 2016 (81 FR 28973)), that
extended FDA's regulatory authority to all tobacco products. Study C
will be an experimental study examining how a hypothetical tobacco
product standard may impact consumers' perceptions, attitudes, and
tobacco use behavioral intentions. Study D will be an experimental
study using behavioral economic methods that seeks to understand how
the availability or lack of availability of menthol cigarettes
potentially impacts adult cigarette smokers' product purchasing
choices. The current request also seeks approval to update the
estimated burden for an additional year of panel replenishment. The
overall purpose of the data collection is to collect information from a
national sample of tobacco users to provide data that may be used to
develop and support FDA's policies related to tobacco products,
including their labels, labeling, and advertising.
    The target population for the panel is tobacco users aged 18 years
and older in housing units and in noninstitutionalized group quarters
in the 50 states and the District of Columbia. A stratified four-stage
sample design was used, with a goal of recruiting 4,000 adult tobacco
users into the sample panel. The sample is designed to allow in-depth
analysis of subgroups of interest and to the extent possible, provide
insight into tobacco users more generally. Replenishment will be
conducted to maintain the panel with a constant number of members
following existing panel recruitment and enrollment methods.
    In the Federal Register of October 23, 2018 (83 FR 53485), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 10 comments; however, only 1
was PRA related.
    (Comment) One commenter supports FDA's establishment of a tobacco
user panel, adding that high-quality research is critical to successful
implementation of many provisions of tobacco policy. The commenter
further stated that the research panel can provide FDA with critical
information on how adult tobacco users respond to tobacco marketing,
product labels, warning statements, and other communications about
tobacco products. The commenter also noted the ability to have its own
panel of tobacco users will allow FDA to gather more reliable
information in a more efficient manner.
    (Response) FDA agrees with this comment and believes the panel will
be a valuable tool for conducting new observational and experimental
studies.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
             Activity/respondent                 Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents   respondent \2\   responses \3\                                                    \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Household Screening Respondent..............          35,885            0.33          11,842  0.13 (8 minutes)..........................           1,539
Panel Member Enrollment Survey..............           4,000            0.33           1,320  0.25 (15 minutes).........................             330
Panel Member Baseline Survey................                            0.33           1,320  0.25 (15 minutes).........................             330
Study A.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study B.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study C.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Study D.....................................                            0.33           1,320  0.33 (20 minutes).........................             436
Panel Replenishment Household Screening               33,355            0.33          11,007  0.13 (8 minutes)..........................           1,431
 Respondent \4\.
Panel Replenishment Enrollment Survey \4\...           4,600            0.33           1,518  0.25 (15 minutes).........................             380
Panel Replenishment Baseline Survey \4\.....                            0.33           1,518  0.25 (15 minutes).........................             380
                                             ------------------------------------------------                                            ---------------
    Total...................................  ..............  ..............  ..............  ..........................................           6,134
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Assumes respondents will participate once over a 3-year period, or 0.33 responses annually.
\3\ Amounts are rounded to the nearest whole number.
\4\ Assumes an estimated 10,285 mail and field household screening respondents during yearly panel replenishment and 1,400 additional panel members will
  be recruited annually as part of the panel replenishment effort, as well as an additional 2,500 household screening respondents during replenishment
  and an additional 400 panel replenishment enrollment and baseline survey respondents should annual attrition rates be higher than expected.

    FDA's burden estimate is based on timed readings of each
instrument, including the mail and field screeners, enrollment survey,
baseline survey, and study A through D questionnaires. Of the total
screening respondents, we expect 25 percent will respond only in the
mail screening (household deemed ineligible), 65 percent will respond
only in the field screening (mail screening nonrespondents), and the
remaining 10 percent will respond in both the mail screening and the
field screening. The latter includes eligible households from the mail
screening that are subsequently field screened to sample the panel
member, and the 10 percent quality control sample of households whose
mail screening ineligibility is verified through in-person screening.
The estimated burden published in the 60-day notice assumed an
estimated 10,285 household screening respondent during yearly panel
replenishment (30,855 total) and 1,400 additional panel members
recruited annually (4,200 total). In this notice, we included 2,500
additional household screening respondents during replenishment, and an
additional 400 panel replenishment enrollment and baseline survey
respondents as part of the panel replenishment effort (should annual
attrition rates be higher than expected). The new total is 33,355
household screening respondents and a total of 4,600 panel members
recruited. Replenishment panel members replace original panel members
and become part of the 4,000-member panel that receives experimental/
observational and panel maintenance surveys. Overall, this extension
reflects an increase of 1,700 hours due to an additional year of panel
replenishment and fielding of studies B, C, and D.

II. References

    The following references are on display at 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; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected. Some may be available at the
website address, if listed. 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. Baker, R., Blumberg, S., Brick, M., et al., 2010, ``American
Association for Public Opinion Research Report on Online Panels,''
Public Opinion Quarterly, 74(4), pp. 711-781.
2. Coen, T., Lorch, J., and Piekarski, L., 2005, ``The Effects of
Survey Frequency on Panelists' Responses. Worldwide Panel Research:
Developments and Progress,'' Amsterdam, European Society for Opinion
and Marketing Research.
3. Nancarrow, C. and Cartwright, T., 2007, ``Online Access Panels
and Tracking Research, The Conditioning Issue,'' International
Journal of Market Research, 49(5), pp. 435-447.
4. Kruse, Y., Callegaro, M., Dennis, J. M., et al., 2009, ``Panel
Conditioning and Attrition in the AP-Yahoo! News Election Panel
Study,'' paper presented at the American Association for Public
Opinion Research 64th Annual Conference.

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10359 Filed 5-17-19; 8:45 am]
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[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Rules and Regulations]
[Pages 24503-24505]
[FR Doc No: 2021-09387]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0136; FRL-10023-01-Region 7]

Air Plan Approval; Missouri; Control of Volatile Organic Compound
Emissions From Wood Furniture Manufacturing Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Missouri on February 15, 2019. This final action will
amend the SIP to revise a Missouri regulation which restricts the
emissions of volatile organic compounds from wood furniture
manufacturing operations in St. Louis City and Jefferson, St. Charles,
Franklin, and St. Louis Counties. These revisions do not have an
adverse effect on air quality. The EPA's approval of this rule revision
is being done in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This final rule is effective on June 7, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2021-0136. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
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 through https://www.regulations.gov or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional information.

FOR FURTHER INFORMATION CONTACT: William Stone, Environmental
Protection Agency, Region 7 Office, Air

Quality Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The EPA is approving revisions to the Missouri SIP received on
February 15, 2019. The revisions are to Title 10, Division 10 of the
Code of State Regulations, 10 CSR 10-5.530 ``Control of Volatile
Organic Compound Emissions From Wood Furniture Manufacturing
Operations'', which restricts the emissions of volatile organic
compounds (VOC) from wood furniture manufacturing operations in St.
Louis City and Jefferson, St. Charles, Franklin, and St. Louis Counties
(hereinafter referred to in this document as the ``St. Louis Area'').
The revisions to the rule specify that this rule only applies to
sources that were existing at the time of the rule's promulgation,
remove restrictive words, update references, and make minor
clarifications and grammatical changes. The revisions are described in
detail in the technical support document (TSD) included in the docket
for this action. The EPA solicited comments on the proposed revision to
Missouri's SIP, and received one comment that was supportive of the
proposed action (86 FR 13264, March 8, 2021).

II. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from June 15, 2018,
to September 6, 2018, and held a public hearing on August 30, 2018. The
State received and addressed six comments from the EPA. As explained in
more detail in the TSD which is included in the docket for this action,
the SIP revision submission meets the substantive requirements of the
CAA, including section 110 and implementing regulations.

III. What action is the EPA taking?

    The EPA is taking final action to amend the Missouri SIP by
approving the State's request to revise 10 CSR 10-5.530 ``Control of
Volatile Organic Compound Emissions From Wood Furniture Manufacturing
Operations.''

IV. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
Missouri Regulations described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 7 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).
    Therefore, these materials have been approved by the EPA for
inclusion in the State Implementation Plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of the EPA's approval, and will be incorporated by reference
in the next update to the SIP compilation.\1\
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    \1\ 62 FR 27968, May 22, 1997.
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V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 action 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).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 6, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the

time within which a petition for judicial review may be filed, and
shall not postpone the effectiveness of such rule or action. This
action may not be challenged later in proceedings to enforce its
requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: April 22, 2021.
Edward H. Chu,

Acting Regional Administrator, Region 7.
    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry ``10-5.530'' to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
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                                                               State
       Missouri citation                  Title           effective date     EPA approval date      Explanation
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                                    Missouri Department of Natural Resources
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                                                  * * * * * * *
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   Chapter 5--Air Quality Standards and Air Pollution Control Regulations for the St. Louis Metropolitan Area
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                                                  * * * * * * *
10-5.530.......................  Control of Volatile           2/28/2019  5/7/2021, [insert
                                  Organic Compound                         Federal Register
                                  Emissions From Wood                      citation]
                                  Furniture
                                  Manufacturing
                                  Operations.

                                                  * * * * * * *
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* * * * *

[FR Doc. 2021-09387 Filed 5-6-21; 8:45 am]
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