<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (2/18/2008)>

<EPA Registration Division contact:

[Akiva Abramovitch,

Registration Division (7505P)

Office of Pesticides Programs

Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, DC 20460-0001

Telephone:<PHONE_NUMBER>

E-Mail Address<EMAIL_ADDRESS>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green and brackets, i.e., “[Dow AgroSciences, LLC],” with the information specific to your action.>

<TEMPLATE:>

<[ Dow Agro Sciences LLC]>

<[7F7248, 3F4188 and 3H5662]>

<	EPA has received pesticide petitions (7F7248, 3F4188 and 3H5662]) from [Dow Agro Sciences LLC], [9330 Zionsville Road, Indianapolis, IN-46268] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of>

<	[chlorpyrifos] in or on the raw agricultural commodity [Crop group 17, grass, forage] at [11] parts per million (ppm), [Crop group 17, grass, hay] at [30] parts per million (ppm), [barley, grain] at [0.5] parts per million (ppm), [barley, straw] at [2] parts per million (ppm), [barley, hay] at [3] parts per million (ppm), and [barley, milled feed fractions] at [1] parts per million (ppm).  A tolerance amendment is also needed for [Cattle, fat] at [0.6] parts per million (ppm), [Goat, fat] at [0.4] parts per million (ppm), [Horse, fat] at [0.5] parts per million (ppm), [Hog, fat] at [0.4] parts per million (ppm) and [Sheep, fat] at [0.4] parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; 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. [The qualitative nature of chlorpyrifos residues in plants and animals is adequately understood and was previously deemed acceptable by the US-EPA in the publication of June 20, 2000, Chlorpyrifos. Revised Product and Residue Chapters of the HED Chapter of RED.  The primary metabolite is known to be 3,5,6-trichloro-2-pyridinol (TCP).]>

<	2. Analytical method. [Adequate enforcement methods are available for determination of chlorpyrifos residues in plant and animal commodities.  The available Analytical Enforcement Methodology was previously reviewed in the June 20, 2000, Chlorpyrifos. Revised Product and Residue Chapters of the HED Chapter of RED.]>

<	3. Magnitude of residues. [Complete residue data for chlorpyrifos on mixed-grasses, (Crop group 17: Grass, hay and Grass, forage) has been submitted by Dow AgroSciences (R. W. McCormick, G. A. Schelle, 2005, Magnitude of Residue of Chlorpyrifos and 3.5.6-Tricloro-2-pyridinol (TCP) in Grass Forage and Hay, Dow AgroSciences unpublished report study ID 040028).   The magnitude of residue of chlorpyrifos were determined by twelve trials following three foliar broadcast applications of Lorsban* 75 and Lorsban* 4E insecticide, at rates of 0.25, 0.5 and 1.0 lb ai/A. The PHI was 7, 14, and 21 days for the three tested rates, respectively.

The impact on animal dietary burden from the use on grasses has previously been assessed by Dow AgroSciences and submitted to the EPA (C. Tiu, Chlorpyrifos in or on Mixed Grasses: Section E, F and G of the Petition for Permanent Tolerances, Dow AgroSciences Internal Report, Study # 061039).  Existing and newly proposed uses involve crops commonly used as feed for livestock: non-grass animal feed crops, such are alfalfa and clover, mixed grasses, corn, soybeans, cereals, etc. were considered.  The animal dietary burden was reviewed and only a doubling of the meat fats was proposed to accommodate the new uses.  Poultry was not affected.  This current NOF now clarifies the doubling for each individual meat fat type based on the tolerances announced by EPA via the Proposed Rule of August 2007 (Federal Register, Vol 72 No 152, Section 180.342, August 8, 2007).  The requested meat fat tolerances are adequately supported.

Residue data for chlorpyrifos in and on barley has previously been submitted by Dow AgroSciences in two studies (C. K. Robb, B. A. Schotts, Residues of Chlorpyrifos in Barley After Ground and Aerial Applications of LORSBAN 4E Insecticide – Residue Study to Provide Data fro Tolerance and Registration, Internal Report of Dow AgroSciences, GH-C 2756, 1992; E. M. Bargar, Magnitude of Residue of Chlorpyrifos in Barley, Internal Report of Dow AgroSciences, GH-C 4132, 1996).  Jointly these studies provide information on ground applications at 11 sites.  The maximum observed residues of chlorpyrifos in or on barley hay, barley grain, and barley straw were 1.79, 0.26 and 1.09 ppm, respectively.  The estimated dietary burden input for barley was reviewed relative to the previously submitted animal feeding studies.  The existing residue tolerance for meat, milk, poultry and eggs are not expected to be exceeded by the proposed use of chlorpyrifos on barley crops (E. Bargar, E. Day, Amendment to Tolerance Petition for Chlorpyrifos in Barley, GH-C 4180, Internal Report of DowAgroSciences, GH-C 4180, 1996).  Substitution of barley into the mix of existing animal feeds with potential chlorpyrifos residues does not impact the tolerance.  The requested tolerances are adequately supported.]>

<B. Toxicological Profile [The toxicological profile and endpoints for chlorpyrifos which supports this petition to establish tolerances were previously published in the IRED document published as of July 31, 2006, Finalization of Interim Reregistration Eligibility Decision (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TRED’s) for the Organophosphate Pesticides, and Completion of the Tolerance  Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides.]>

<	1. Acute toxicity.  [as per the IRED, February, 2002 (EPA 738-R-01-007), an acute toxicological endpoint was established by the agency based on cholinesterase (ChE) inhibition (28-40%) after exposure of male rats to 1 mg/kg/day (Mendrala and Brzak, 1998). The acute reference dose was established by the Agency, aRfD = 0.005 mg/kg/day, based on a NOAEL = 0.5 mg/kg/day, and uncertainty factor of 100. The reference dose was adjusted for susceptible population subgroups (infants, children, females 13-50) by applying an additional FQPA = 10x (aPAD = 0.0005 mg/kg/day).]>

<	2. Genotoxicty. [Per the Human Health Risk Assessment for chlorpyrifos issued by the EPA June 8, 2000, chlorpyrifos was evaluated for carcinogenic potential in both rats (2 >studies), and mice (2 studies). There was no evidence of carcinogenicity.  Chlorpyrifos is not mutagenic in bacteria, or mammalian cells, but did cause slight genetic alterations in yeast and DNA damage to bacteria. In addition, chlorpyrifos did not induce chromosome aberrations in vitro, was not

clastogenic in the mouse micronucleus test in vivo, and failed to induce

unscheduled DNA synthesis in isolated rat hepatocytes.]

<	3. Reproductive and developmental toxicity. [Per the Human Health Risk Assessment for chlorpyrifos issued by the EPA June 8, 2000, based on review of several studies for developmental toxicity in rats, mice and rabbits, the EPA retained the 10X FQPA safety factor.  Their assessment is summarized as follows:  In one rat study, developmental effects were noted at 15 mg/kg/day (highest dose tested, HDT), that were also associated with maternal toxicity, while another rat study failed to observe developmental effects at 15 mg/kg/day.  Developmental effects were also noted at higher doses in mice at 25 mg/kg/day and rabbits at 140 mg/kg/day. In both mice and rabbits, the developmental effects occurred at maternally toxic doses.  Relative to evaluation of reproductive toxicity using standard guideline methods, chlorpyrifos induced reproductive toxicity in one generation of rats, but only at dose levels that induced parental toxicity.>

From the June, 2000 risk assessment, the EPA reported that chlorpyrifos was associated with delayed alterations in rat brain development in offspring of exposed mothers from the developmental neurotoxicity study.  Specifically, pups of the 1 mg/kg/day group exhibited significant dose- and treatment-related decreases in measurements of the parietal cortex in female offspring.  Subsequest historical control morphometric data have since been generated and submitted that indicate this observation was within the range of normal variation.

In the June 2000 risk assessment, the EPA notes that several studies in the peer reviewed literature and results of the guideline developmental neurotoxicity study are supportive of the possibility that chlorpyrifos exposure may affect brain development.  The EPA noted that there are suggestive data that these effects may arise independent of cholinesterase inhibition.  After subsequent review, (USEPA, Revised OP Cumulative Risk Assessment, June 10 2002) of this literature, the EPA reported that developmental effects are not likely to occur at doses below those associated with inhibition of cholinesterase.]

<	4. Subchronic toxicity. [Per the Human Health Risk Assessment for Chlorpyrifos issued by the EPA June 8, 2000, the EPA has established a Dermal NOAEL of 5 mg/kg/day with for short-term dermal regulation based on the 21-day dermal rat study.  Likewise, the EPA has established an Inhalation NOAEL = 0.1 mg/kg/day based on two 90 day rat inhalation studies and the developmental neurotoxicity study.  An MOE of 100 is established for worker and males.   An MOE of 1000 is established for susceptible population subgroups (infants, children, females 13-50).]>

<	5. Chronic toxicity. [The reference for chronic toxicological endpoint (cRfD) was set by the Agency based on significant plasma and red blood cells (RBC) ChE inhibition at a LOAEL = 0.22 to 0.3 mg/kg/day across five studies (1 year dog, 90 day dog, 2 year rat, 90 day rat, developmental neurotoxicity in rat). Therefore the cRfD = 0.0003 mg/kg/day. The reference dose was adjusted for susceptible population subgroups (infants, children, females 13-50) by applying an additional FQPA = 10x (cPAD = 0.00003 mg/kg/day).]>

<	6. Animal metabolism. [Nature of residue studies, conducted in goats and hens have shown that the metabolic pathway involves the conversion of chlorpyrifos to 3,5,6-trichloropyridinol (TCP).

>

<	7. Metabolite toxicology. [The primary metabolite is known to be 3,5,6-trichloropyridinol (TCP).  The EPA Toxicology Branch has concluded that TCP is not of toxicological concern.  TCP is not included in the tolerance expression or considered for dietary assessment purposes.]>

<	8. Endocrine disruption. [Chlorpyrifos has been extensively studied for a wide range of biological effects, including effects on endocrine function.  No endocrine effects have been found in experimental animals that have been exposed to very high levels of chlorpyrifos (several thousands of times higher than human exposure) from conception to birth to adulthood to old age.  Toxicologists at regulatory agencies throughout the world evaluate these chlorpyrifos studies, and endocrine effects have not been identified as an issue.]>

<C. Aggregate Exposure [

>

xposure Evaluation Model™ (DEEM-FCID, version 2.16, Exponent, Inc., Washington, DC-20036) was used for conduct of acute and chronic dietary risk analyses.  DEEM is used to estimate exposure to a pesticide chemical in foods comprising the diets of the U.S. population, including population subgroups.  DEEM contains food consumption data as reported by respondents to the USDA Continuing Surveys of Food Intake by Individuals (CSFII) conducted in 1994-1996 and 1998 and food translation to Raw Agricultural Commodities (RACs), as indicated by EPA/USDA FCID recipe set as of August, 2002.  Exposures were assessed against the aPAD and the cPAD, for the acute and chronic scenarios, respectively.]>

<	i. Food. [The highly refined Tier III/IV dietary assessments issued by EPA (US EPA, Memorandum Chlorpyrifos, Acute Dietary Risk Assessment for Chlorpyrifos, Revised after Public Comments: Chemical No. 59101: DP Barcode D263890, June 22, 2000; US EPA, Memorandum Chlorpyrifos. Chronic Exposure Assessment for Chlorpyrifos RED with Updated Values for Anticipated Residues, Revised After Public Comments: Chemical No. 59101: DP Barcode D263889, June 22, 2000) have been updated by Dow AgroSciences.  General methodology established by the EPA (Human Health Risk Assessment for Chlorpyrifos issued by the EPA June 8, 2000) was followed for the highly refined acute probabilistic dietary exposure and the corresponding chronic exposure analysis.  PDP (  HYPERLINK "http://www.ams.usda.gov/science/pdp/Download.htm"  http://www.ams.usda.gov/science/pdp/Download.htm ) and FDA Pesticide Program Residue Monitoring (  HYPERLINK "http://www.cfsan.fda.gov/~dms/pesrpts.html"  http://www.cfsan.fda.gov/~dms/pesrpts.html ) data were used to the greatest extent possible, along with field trial data, and cooking and processing factors to assess dietary exposures.

The updated assessment covers the comprehensive listing of tolerances announced by EPA via the Proposed Rule of August 2007 and incorporates new monitoring data which is available primarily from USDA PDP (2002 to 2006).  Data from FDA has been incorporated for a few key commodities.  For several blended commodities, average residue data from trials was adjusted for percent crop treated (PCT).  In a few instances tolerance values were used instead of residue or monitoring data.  Most notably the grape tolerance of 0.01 ppm was employed; with enforcement of the tolerance, exposure is reduced and the PDP monitoring data is not applicable.  Based on market data from Doane, minor shifts in overall percent crop treated (PCT) values which have occurred have been included in the updated assessments.  Over 60 individual residue (RDF) files were used in the updated acute assessment; most were created from the newer monitoring data; a very few were reused from the older 2000 assessment previously conducted by EPA.

The updated assessments were used as a starting point to assess the impact of the proposed uses in barley and grasses for this petition.  The updated assessment relied on the 2002 PDP data of beef adipose with no detection of chlorpyrifos above the LOD of 2.8 ppb to derived an average residue value for the chronic assessment and to create a RDF file for the acute assessment.  These were used for the fats of beef, goat, and sheep.   The 2005 PDP data on 353 pork adipose samples with only 1 residue at 2.5 ppb above the LOD of 1.5 ppb was used in a similar fashion for pork fat.  To assess the dietary impact of the grasses, the monitoring average for these fats was doubled for the chronic assessment and a factor of 2 was applied in DEEM to the RDF files for the acute assessment.  A doubling of the value derived from the monitoring is believed to be adequate, given the extremely low detection rate historically observed.

The anticipated residue in barley is based upon average field trial results of 0.084 ppm and an estimate of 10.0 % crop treated; current grain crops (corn, sorghum and wheat) have PCT values of 5% or less.  The resulting average anticipated residue of 0.0084 ppm was applied barley.  As applicable, wheat processing factors from the 2000 assessment were adopted.]>

<	ii. Drinking water. [To account for water exposure, the most recent PDP data sets for various water analyses over all years from 2002 to 2005 were used as direct input to DEEM.  PDP results were reported as four types of water: bottled water, finished water, drinking water and unfinished water in a total of 3614 analyzed samples.  In all cases, no observable residues were reported.  The LODs ranged from 30 ppt to 6 ppt, so an average weighted LOD of 15.45 ppt was calculated from all observations.  A value of ½ this LOD was used in DEEM for both “Water, direct, all sources” and “Water, indirect, all sources”.  The recent PDP data information on water is congruent with historical drinking water monitoring data which shows no detectable residues in finished drinking water supplies. (Blomquist, et al., 2001. Pesticides in Selected Water-Supply Reservoirs and Finished Drinking Water, 1999-2000: Summary of Results from a Pilot Monitoring Program.  Open-File Report 01-456, US Geological Survey).]>

<	2. Non-dietary exposure. [Non-dietary exposure to chlorpyrifos is now extremely limited.  Containerized baits in child-resistant packaging is the only residential use which may be applied by the homeowners. The Agency has concluded that this use is not expected to results in exposures of concern.  Therefore, there is no non-dietary acute, chronic, short- or intermediate-term exposure applicable.  For further details, refer to the Human Health Risk assessment for Chlorpyrifos, June 8, 2000.

Residential post application exposure may occur when people enter a treated golf course, or following application for mosquito control by a public agency. This residential exposure is expected to be of short-term duration (one day to one month). The Agency has published the conclusion of the residential assessment.  For residential post application risk, the target MOE is 1000, or greater.  In summary for golfers exposed post application of 1 lb ai/A, MOE’s are 1,500 to 2,400. Following aerial and ground-based fogger mosquito adulticide use, MOEs are 17,000 and 29,000 for children and adults, respectively. For further details, refer to the Human Health Risk assessment for Chlorpyrifos, June 8, 2000.

An aggregate risk assessment combines risk from dietary exposure (food and drinking water) and residential exposure (post-application of adults and children from treated golf courses and mosquito control campaigns).  The acute, short-term and chronic aggregate assessments by the Agency in the published IRED for chlorpyrifos remain sufficient.  The resulting values of this updated assessment for current dietary and water exposures are comparable or less than those assumed post-mitigation for the previous aggregate assessment.  No additional assessments are needed and adequate MOEs are achieved.]>

<D. Cumulative Effects>

<	[Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency considers “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity.”  EPA has completed its assessment of cumulative risks from the organophosphate (OP) class of pesticides, as required by the Food Quality Protection act (FQPA) of 1996.  In addition, the individual OP’s have also been subject to individual review process, which resulted in the issuance of Interim Reregistration Eligibility Decisions (IREDs) for 22 OP’s, interim Tolerance Reassessment and Risk Management Decisions (TREDs) for 8 OP’s and a Reregistration Eligibility Decision (RED) for one OP.  EPA has concluded after completing its assessment that pesticides covered by IREDs and TREDs are eligible for reregistration and meet the safety standard under Section 408(b)(2) of the FFDCS.  The cumulative risk assessment and supporting documents are available on the Agency’s website at   HYPERLINK "http://www.epa.gov/pesticides/cumulative"  www.epa.gov/pesticides/cumulative  and in the docket (EPA-HQ-OPP-2006-0618.  Based on the updated dietary assessment, the proposed uses for barley and grasses do not increase potential exposure in a way that would alter the conclusions of the previous cumulative assessment.]>

<E. Safety Determination>

<	1. U.S. population. [Using the exposure assumptions described above, Dow AgroSciences has concluded the estimated chronic dietary exposure and risk from the current and proposed new tolerances do not exceed HED's level of concern [i.e., >100 % of the chronic population adjusted dose (cPAD)] for the general US population.  The estimated dietary exposure for the general U.S. population was estimated to be 0.000006 mg/kg/day or 2% of the chronic reference dose.  EPA generally has no concern for exposures below 100% of the chronic PAD because the chronic PAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.

The estimated acute dietary exposure and risk do not exceed HED's level of concern [i.e., >100 % of the acute population adjusted dose (aPAD)] for the general US population at the 99.9th %ile of exposure.  The estimated dietary exposure and risk for the general U.S. population at the 99.9th percentile exposure was 0.000177 mg/kg/day, or 3.5% aPAD.

Dow AgroSciences concludes that there is a reasonable certainty that no harm will result to US-general population from aggregate exposure to chlorpyrifos residues.  When exposures are aggregated for adults for diet, drinking water and post-applications to golf courses and mosquito control campaigns, the MOE’s are above the Agency’s threshold of concern.]>

<	2. Infants and children. [The FQPA = 10X has been maintained by the EPA for additional protection to infants, children and females 13-50 years old.  The aPAD is 0.0005 mg/kg/day and the cPAD is 0.00003 mg/kg/day for infants, children and females at the age of conceiving (13-50 year).

Using the exposure assumptions described above, Dow AgroSciences has concluded the estimated chronic dietary exposure and risk from the current and proposed new tolerances do not exceed HED's level of concern [i.e., >100 % of the chronic population adjusted dose (cPAD)] for all subpopulations.  For children 1 – 2 years old, the most highly exposed population subgroup, dietary exposure was 0.00016 mg/kg/day, or 54.4% of the cPAD.  EPA generally has no concern for exposures below 100% of the chronic PAD because the chronic PAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.

At the 99.9th percentile, acute risks are not of concern for the most highly exposed population sub-group, children 1-2 years old.  For children 1 – 2 years old, estimated dietary exposure was 0.00036 mg/kg/day, or 71% aPAD.

Dow AgroSciences concludes that there is a reasonable certainty that no harm will result to children from aggregate exposure to chlorpyrifos residues.  When the exposures are aggregated for children for diet, drinking water and mosquito control campaigns, the MOE’s are above the Agency’s threshold of concern.]>

<F. International Tolerances>

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ఀܪ栖䏋䨰"࠼喁Ĉ⪐∁t the MRLs established by different agencies are not harmonized.  The differences may be attributable to a diverse set of use patterns, local efficacy needs, variations in guidelines for conducting field crop residue studies and varying calculation methods to propose tolerances.]

>

 PAGE

 PAGE   9


[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62426-62429]
[FR Doc No: 2022-22301]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1026]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Text Analysis of
Proprietary Drug Name Interpretations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the
collection of information by November 14, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Text Analysis of Proprietary Drug Name
Interpretations.'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].
    For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, [email protected].

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.

Text Analysis of Proprietary Drug Name Interpretations

OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform all three topic areas.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings are improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our home page,
which can be found at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    As part of the prescription drug regulatory review process,
sponsors propose proprietary names for their products. These names
undergo a proprietary name review that involves the Office of
Surveillance and Epidemiology, the relevant medical office, and OPDP.
OPDP reviews names to assess for alignment with the FD&C Act, which
provides, among other things, that labeling can misbrand a product if
false or misleading representations are made (see 21 U.S.C. 321(n) and
352(a)). A proprietary name that appears in labeling could result in
such misbranding if it is false or misleading. OPDP reviews, among
other things, whether names: (1) overstate the efficacy or safety of
the drug, (2) suggest drug indications that are not accurate, (3)
suggest superiority without substantiation, or (4) are of a fanciful
nature that misleadingly implies unique effectiveness or composition.
It would be helpful in OPDP's review of promotional implications of
proprietary names for data on consumer and prescriber interpretations
of proposed proprietary names to be more readily available for
consideration. The proposed research will use text analysis (e.g.,
topic modeling and sentiment analysis) to learn how consumer and
primary care physician (PCP) populations interpret prescription drug
names, which will assist OPDP's consideration of promotional
implications.
    This proposed research builds upon and extends OPDP's research
entitled ``Empirical Study of Promotional Implications of Proprietary
Prescription Drug Names'' (86 FR 14440; March 16, 2021). That research
involves an experimental design intended to assess names that
potentially overstate the efficacy of a product. In contrast, the
proposed research involves a survey design that comprises primarily
open-ended questions intended to generate text for analysis, an
approach that is unrestricted in its ability to assess text with
different types of promotional implications (e.g., minimization of risk
and unsubstantiated claims of superiority, in addition to overstatement
of efficacy). The proposed research will add to the depth and breadth
of knowledge we can draw from during the review of proposed proprietary
drug names.
    The key objectives of the proposed research are as follows:
    1. To apply new techniques such as topic modeling and sentiment
analysis (forms of text analysis) to answer OPDP's research questions
about

consumer and PCP interpretations of proprietary prescription drug
names.
    2. To help develop a methodological approach for assessing consumer
and prescriber interpretations of drug names, which can potentially be
used in the future as a standard assessment tool.
    Our methodological approach will involve nationally representative
samples. Consumers will be recruited from Ipsos Public Affairs
KNOWLEDGEPANEL. PCPs will be recruited using a two-stage approach that
will begin with a purchased list of PCPs based on the American Medical
Association Physician Masterfile. These members will then be matched to
one or more sample provider lists to recruit PCP participants for this
study. We propose a sample of 300 consumers and 300 PCPs for the main
study. We have designed a within-subjects experiment in which
participants will be exposed to multiple drug names to maximize power
to find differences with this sample size. The stimuli will comprise 60
experimental names and 60 control names. Participants will be
randomized to 1 of 10 groups so that no one responds to more than 12
names in total. Each participant will see six experimental names and
six control names. The experimental names will be names with suspected
promotional implications, whereas the control names will not have
suspected promotional implications. Names will be viewed in random
order. Participants will respond in open-ended text boxes about their
perceptions of each drug name. Supplementary closed-ended questions may
also be presented. We will conduct text analysis of the responses and
present descriptive results for individual drug names by participant
cohort (i.e., consumers versus PCPs), and we will also code and compare
responses across types of drug names.
    In the Federal Register of November 1, 2021 (86 FR 60254), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments that were
Paperwork Reduction Act (PRA) related. Within those submissions, FDA
received multiple comments that the Agency has addressed. For brevity,
some public comments are paraphrased and therefore may not state the
exact language used by the commenter. All comments were considered even
if they were not fully captured by our paraphrasing in this document.
Comments and responses are numbered here for organizational purposes
only.
    (Comment 1) One comment contended that FDA should revise the
questionnaire to capture real-world conditions more closely in which
PCPs and consumers form impressions of proprietary names. The comment
suggested that while FDA stated that ``[t]he experimental names will be
names with suspected promotional implications'' in the Federal Register
notice, the Agency does not approve proprietary names with ``suspected
promotional implications.'' The comment also stated that FDA's proposed
approach would not mimic the real-world conditions in which mention of
a drug's indication triggers a requirement to provide safety
information as well. The comment suggested that either FDA could
consider providing only the drug name in a way that is similar to the
information provided in reminder advertising, or it could provide a
balanced presentation as required under the relevant regulations.
    (Response 1) As previously described, sponsors propose proprietary
names for their products, including those with promotional
implications, as part of the prescription drug regulatory review
process. One purpose of this study is to investigate methodological
options for collecting insights from consumers and providers during the
review process that might help FDA make determinations about whether
drug names have promotional implications that misbrand a product. As
for real-world conditions, our initial focus is on establishing
correlation or causation in a more controlled setting--such as a
randomized controlled trial or the type of rigorous experimental study
we have planned.
    (Comment 2) One comment suggested that FDA does not state how the
information obtained from the specified study will be useful or how it
will be used to inform name reviews. The comment then asserted that the
link between this information and the implementation of FDA's
misbranding authorities and proprietary name review, and thus the
practical utility of the survey, is unclear.
    (Response 2) FDA's review of proprietary names is conducted to help
ensure that proposed proprietary names do not contribute to misbranding
a drug or to other violation(s) of the FD&C Act and Agency regulations,
particularly when that proprietary name appears in labeling. (See,
e.g., 21 U.S.C. 321(n) and 352(a).) We conduct our review of
proprietary names in accordance with applicable legal authorities.
    The existing study is a first step in exploring the utility of text
analysis for collection of data on proprietary prescription drug names.
Determining how names are processed and understood by consumers and
healthcare providers (HCPs) is important information to be considered
in the review of proposed prescription drug names. This program of
research is being conducted to increase the body of evidence upon which
experts can rely when assessing proposed proprietary names.
    (Comment 3) One comment stated that FDA should revise question 1.
The comment advised that the instructions should make clear that the
respondent can write ``no impression'' if the name does not, in the
respondent's view, communicate any information related to the
particular attribute of the drug. In addition, the comment stated that
the last question, asking respondents to write a brief narrative, is
confusing and unnecessary and that the objective and practical utility
of this exercise are unclear.
    (Response 3) It was clear in our cognitive interviews that if
respondents had no impression based on a drug name, they would be
likely to type ``nothing'' or ``no impression'' as their response. The
purpose of the last exercise is to examine the utility of an implicit
measure of attitudes for comparison with the more explicit measures. If
this measure proves to be unproductive in pre-testing, we may omit it
from the main study. For instance, this implicit measure might be
considered unproductive if it does not prompt any additional, unique
text relative to what is offered in response to the earlier open-ended
items.
    (Comment 4) Two comments similarly claimed that questions two
through six are leading, potentially confusing, duplicative of another
question, or otherwise unnecessary. One comment recommended removing
these questions.
    (Response 4) These questions have been included as a way of
validating the information recorded in question one. Based on other
comments, such as one that challenged the use of yes/no questions, we
have revised them to a 5-point Likert scale, ranging from strongly
disagree to strongly agree. We will assess these questions further as
part of pre-testing.
    (Comment 5) One comment stated that FDA should limit patient and
PCP participation to those who have experience with the fictitious drug
indications. It further asserted that FDA should provide detail on how
the patients and PCPs will be selected and how FDA will help ensure
these participants have relevant experience. The comment suggested that
FDA could add an open-ended question requesting that PCPs provide
information about

their experiences in the disease areas for which the fictitious drugs
are intended, patient populations, and settings to understand the real-
world value of the responses.
    (Response 5) Due to the large number of drug names and indications
to be included in this study, the comment's suggestion is not feasible.
However, we will add a measure to the screener to assess PCPs' and
consumers' experiences with each of the indications. This variable can
then be used as a covariate in analyses.
    (Comment 6) One comment suggested that to ensure that the survey
isolates the impressions given by the proprietary name, FDA should use
only fictitious names for the survey.
    (Response 6) We have removed all real drug names from the study and
replaced them with fictitious names.
    (Comment 7) One comment recommended removing all yes/no questions
from the survey.
    (Response 7) We have done so, changing the yes/no items to Likert
scale items.
    (Comment 8) One comment recommended that FDA should acknowledge
that proposed names may include ``permissible suggestions'' and should
include such fictitious examples. The comment conjectured that the
survey appears to focus only on potential impermissible suggestions
that may result from a drug's proprietary name. The comment submitted
that proposed names should also be included that, for example, suggest
the dosage form, frequency of delivery, structure of the drug, or
general category of the drug's indications.
    (Response 8) A previous study by this research team did include
names such as those suggested above (e.g., with the drug's indication
embedded in the name). Those names are not included here to avoid
duplication.
    (Comment 9) One comment stated that FDA should explain its
methodology for the text analysis and allow for stakeholder feedback on
the proposed text analysis methodology.
    (Response 9) We will examine and present descriptive results for
individual names. However, given our goals of understanding promotional
implications of prescription drug names across consumers and PCPs, we
are also interested in whether there are differences in topic
distributions across our treatment and control arms (control versus
promotional implications) and between populations (consumers and PCPs).
We will use topic modeling and sentiment analysis to answer those
questions. We have described the purpose of the study, the design, and
the population of interest, and we have provided the questionnaire to
numerous individuals upon request.
    (Comment 10) One comment expressed concerns about how degrees or
levels of misbranding may be established or standardized for evaluating
proposed proprietary prescription drug names. It stated that no
information has yet been provided by FDA to inform how such
standardization will be developed.
    (Response 10) This study is not intended either to establish
degrees or levels of misbranding or to standardize levels of
misbranding for the evaluation of proposed drug names. The key
objectives of the proposed research are to apply new techniques such as
topic modeling and sentiment analysis to answer OPDP's research
questions about consumer and PCP interpretations of proprietary
prescription drug names and to help develop a methodological approach
for assessing consumer and prescriber interpretations of drug names.
    (Comment 11) A comment objected that FDA has not provided any
information on how it will select target names to include in the pre-
test and subsequently decide which target names will be used in the
main study. The comment expressed concerns that the pre-test will not
be able to develop multiple distinct levels of efficacy or indication
implication among target names that will be reliably identifiable by
HCPs or consumers. The comment asserted that a proprietary name may not
be reliably classified and separated into multiple levels of
implication.
    (Response 11) Our full stimuli are under development during the PRA
process. We do not make draft stimuli public during this time because
of concerns that this may contaminate our participant pool and
compromise our research. In our research proposals, we describe the
purpose of the study, the design, the population of interest, and the
estimated burden.
    Names will be intentionally developed to have promotional
implications (e.g., overstatement of efficacy). Many of the names were
used in our cognitive interviews. In addition, we will conduct up to
two pre-tests, at which point, if any names are not distinguishable
from those composed of random syllables, they will be replaced. A
similar process was used in another recent study, with reliable
results. Participants did distinguish between names created from random
syllables and those with promotional implications.
    (Comment 12) One comment advised that the pronunciation offered to
a respondent would influence a respondent's impressions and that it
would be important for FDA to control for this influence. The comment
opined that the pronunciation should result in as neutral a reading as
possible, not emphasizing any particular aspect of a name.
    (Response 12) All drug names were recorded by the same voiceover
specialist in as neutral a manner as possible.
    (Comment 13) A comment similarly asserted that the impression
formed from a visual cue (drug name written out) would influence and be
influenced by an audio cue and vice versa. The comment contended that
there would be less bias introduced by listening first to an audio cue.
The comment also recommended that an audio cue first be provided,
followed by the question about hearing the name, and that the visual
image of the name would be presented followed by the question about
seeing the name.
    (Response 13) We agree that people access both the orthographic and
phonological interpretations when they read. However, since our main
comparison is within subjects, it is likely that there is some
consistency in the order in which any one respondent listens to the
pronunciation versus reading the word, and so any variation that may
exist should not confound the effects of their own interpretation of
the drug names. In addition, the comment's suggestion would double the
number of open-ended questions for every drug name, increasing the
survey burden substantially.
    (Comment 14) One comment suggested altering the order of the
prompts so that after gaining impressions following the audio and
visual cues, the brief story or narrative prompt follows.
    (Response 14) The currently proposed questionnaire follows this
order.
    (Comment 15) One comment argued that prompts should not be
``double-barreled'' and should not lead or prime the respondent to find
benefits or other meanings where there may be none. The comment
suggested that questions should ask separately about benefits and how
well the drug would work and then also ask separately about risks and
side effects. The comment suggested rephrasing to ``Does the drug name
suggest the drug may have a benefit?'' or ``Does the drug name make you
think about how well it might work?''.
    (Response 15) We have edited the open-ended section of the study so
that these questions are no longer separate items but merely
instructions preceding the first question. The phrasing the

comment suggested is likely to lead to one-word answers ``yes'' or
``no,'' which does not provide the type of text response that is needed
to conduct text analysis on the data. We did find in cognitive
interviews that participants who did not perceive any meaning from a
specific drug name said they would be likely to type ``nothing'' into
the open-ended text box. Thus, we believe the study in its current form
does allow for this possibility.
    (Comment 16) One comment suggested very general questions should be
asked first and then those that are more specific.
    (Response 16) We have ordered the prompts from general to specific
in line with the suggested comment.
    (Comment 17) One comment proposed that researchers may want to
consider reducing the number of drugs queried in the survey from 12 to
6 to elicit the richest text data from respondents and that it may be
helpful to give a minimum word count for text responses.
    (Response 17) Six drugs will not allow for enough power to make
comparisons between the groups. However, if we find that we get many
breakoffs (participants who begin the survey but do not complete it) in
the pre-test (suggesting the survey burden is too high), we will
reconsider the study design.
    (Comment 18) One comment recommended that an iterative plan for
analysis be developed such that there are checks for both internal and
external validity at specified intervals. It further proposed that
researchers may want to consider a context-specific analysis plan and
argued that one common analysis approach or dictionary may not measure
risk, side effects, and other constructs accurately across all drugs.
    (Response 18) Though the topic modeling approach is designed to be
exploratory for this study, we will calculate coherence metrics to
assess model fit as well as perform validation exercises to assess if
the generated topics can be easily interpreted.
    (Comment 19) One comment recommended that an iterative plan for
analysis be created based on a set of preliminary data along with the
other research materials, such as the questionnaire, sampling plan,
etc., so that it can be reviewed before execution of the full research.
    (Response 19) We appreciate the comment. The pre-test will provide
the valuable insight to create a specific analysis plan for the main
study. The pilot data will help us assess assumptions about how
respondents will respond to target names.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               General Consumer Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 screener (assumes 80% eligible)....              22               1              22  0.08 (5 minutes).........................             1.8
Pretest 1 survey.............................              17               1              17  0.33 (20 minutes)........................             5.6
Pretest 2 screener (assumes 80% eligible)....              22               1              22  0.08 (5 minutes).........................             1.8
Pretest 2 survey.............................              17               1              17  0.33 (20 minutes)........................             5.6
Main study screener (assumes 80% eligible)...             413               1             413  0.08 (5 minutes).........................              33
Main study survey completes..................             330               1             330  0.33 (20 minutes)........................           108.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     PCP Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 screener (assumes 30% eligible)....              57               1              57  0.08 (5 minutes).........................             4.6
Pretest 1 survey.............................              17               1              17  0.33 (20 minutes)........................             5.6
Pretest 2 screener (assumes 30% eligible)....              57               1              57  0.08 (5 minutes).........................             4.6
Pretest 2 survey.............................              17               1              17  0.33 (20 minutes)........................             5.6
Main study screener (assumes 30% eligible)...           1,100               1           1,100  0.08 (5 minutes).........................              88
Main study survey completes..................             330               1             330  0.33 (20 minutes)........................           108.9
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             374
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As with most online and mail surveys, it is always possible that
some participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage for both samples in the
study.

    Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22301 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Pages 62315-62316]
[FR Doc No: 2018-26119]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-18-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Request Under
Blanket Authorization

    Take notice that on November 15, 2018, Southern Star Central Gas
Pipeline, Inc. (Southern Star), 4700 Highway 56, Owensboro, Kentucky
42301, filed in the above referenced docket a prior notice request
pursuant sections 157.205, 157.208, and 157.210 of the Commission's
regulations under the Natural Gas Act (NGA) and its blanket certificate
issued in Docket No. CP82-479-000 for authorization to construct,
operate, and maintain its proposed Blackwell Redundant Compression
Project. Southern Star proposes to install a new 4,760 horsepower (hp)
gas-fired, turbine-driven compressor unit, along with appurtenant and
ancillary facilities, all located at its Blackwell Compressor Station
in Kay County, Oklahoma. Southern Star states that the Blackwell
Redundant Compression Project is designed to create redundant
compression at its Blackwell Compressor Station to maintain reliability
in case routine maintenance or unexpected outages. Southern Star avers
that it will limit the compression used at the Blackwell Compressor
Station so that it does not exceed the certificated horsepower of 8,400
hp. Southern Star estimates the cost of the proposed project to be
$28,496,850, all as more fully set forth in the request which is on
file with the Commission and open to public inspection.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's website web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Cindy Thompson, Manager, Regulatory, Southern Star Central Gas
Pipeline, Inc., 4700 Highway 56, Owensboro, Kentucky 42301, by phone at
(270) 852-4655 or by email at [email protected].
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission,

file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR
385.214) a motion to intervene or notice of intervention and pursuant
to section 157.205 of the regulations under the NGA (18 CFR 157.205), a
protest to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for filing a protest. If a
protest is filed and not withdrawn within 30 days after the allowed
time for filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: November 26, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-26119 Filed 11-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Page 84566]
[FR Doc No: 2016-28164]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-357-000]

MPower Energy; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding
MPower Energy's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 6, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: November 16, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-28164 Filed 11-22-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Page 44110]
[FR Doc No: 2022-15843]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2336-101]

Georgia Power Company; Notice of Waiver Period for Water Quality
Certification Application

    On July 18, 2022, Georgia Power Company submitted to the Federal
Energy Regulatory Commission (Commission) a copy of its application for
a Clean Water Act section 401(a)(1) water quality certification filed
with Georgia Department of Natural Resources, Environmental Protection
Division (Georgia EPD), in conjunction with the above captioned
project. Pursuant to 40 CFR 121.6 and section [4.34(b)(5), 5.23(b),
153.4, or 157.22] of the Commission's regulations,\1\ we hereby notify
the Georgia EPD of the following:
---------------------------------------------------------------------------

    \1\ 18 CFR [4.34(b)(5)/5.23(b)/153.4/157.22].
---------------------------------------------------------------------------

    Date of Receipt of the Certification Request: June 24, 2022.
    Reasonable Period of Time to Act on the Certification Request: June
24, 2023.
    If Georgia EPD fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: July 19, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-15843 Filed 7-22-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61791]
[DOCID:fr26oc05-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-31-000]

Algonquin Gas Transmission, LLC; Notice of Proposed Changes in
FERC Gas Tariff

October 19, 2005.

    Take notice that on October 14, 2005, Algonquin Gas Transmission,
LLC (Algonquin) tendered for filing as part of its FERC Gas Tariff,
Fifth Revised Volume No. 1, the following tariff sheets, effective
November 14, 2005:

First Revised Sheet No. 570
First Revised Sheet No. 571
First Revised Sheet No. 588

    Algonquin states that copies of its filing have been served upon
all affected customers of Algonquin and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5910 Filed 10-25-05; 8:45 am]

BILLING CODE 6717-01-P