[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63218-63219]
[FR Doc No: 2013-24785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1170]

Draft Guidance for Industry on Chronic Hepatitis C Virus
Infection: Developing Direct-Acting Antiviral Drugs for Treatment;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Chronic
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs
for Treatment.'' The purpose of this guidance is to assist sponsors in
all phases of development of direct-acting antiviral (DAA) drugs for
the treatment of chronic hepatitis C. This guidance revises and
replaces a previous draft guidance for industry entitled ``Chronic
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents
for Treatment'' issued on September 14, 2010.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 23, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-
Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is
to assist sponsors in all phases of development of DAA drugs for the
treatment of chronic hepatitis C. This guidance revises the draft
guidance for industry entitled ``Chronic Hepatitis C Virus Infection:
Developing Direct-Acting Antiviral Agents for Treatment'' issued in
September 2010. Significant changes in this revision include:
     Details on phase 2 and phase 3 trial design options for
the evaluation of interferon (IFN)-free and IFN-containing regimens in
treatment-na[iuml]ve and treatment-experienced populations, including
DAA-experienced populations.
     Revised primary endpoint to sustained virologic response
at 12 weeks post-treatment cessation.
     Greater emphasis on DAA drug development in special
populations including trial design options for human immunodeficiency
virus/hepatitis C virus co-infected patients, patients with
decompensated cirrhosis, and patients pre- or post-liver transplant.
     More details on clinical virology considerations for DAA
drugs.

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on developing
DAA drugs for the treatment of chronic hepatitis C virus infection. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 have been approved
under OMB control number 0910-0014, the collections of information in
21 CFR part 314 have been approved under OMB control number 0910-0001,
and the collections of information referred to in the guidance for
industry ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control number
0910-0581.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24785 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P


Preliminary Draft Exempting critical use of methyl bromide   reproposal 06/ 22/ 2004 Presentation of co proposals The discussion on the co proposals should be clarified. The current draft is confusing since the two ideas are mingled. We suggest delineating each proposal more clearly, and offer a comparison thereafter. p. 39: If allocations are by sector, then reporting would have to be by sector as well.

Stockpile Are there restrictions on later use of CSA allowances designated in 2005, but that were not used in 2005?

Characterization of the March Meeting p. 10: # 6 and 7 of the decisions are not mentioned in the preamble. Are these terms not relevant?

Allowances for farmers ( CUPs) p. 44: We suggest that this discussion be scaled back significantly. p. 45: Discussion seems repetitive ( e. g., Sections VIII " A," " B," and " C" seem to go over the same ground). p. 45: The contexts of sentences in the 3rd paragraph ( above section A) are not clear. p. 47: We believe that allowing 3rd party purchase is unlikely to enhance liquidity. Also, the discussion at the top of p. 47 is awkward. p. 48: Is EPA going to make " best use"/" best practice" judgments in making critical user allocations? p. 51: The rationale for the following statement isn't clear: "  CUP holders would have an incentive to sell their permits to producers and importers early in the year in order to obtain revenues as quickly as possible." p. 52: There is no discussion of CSAs, only CUAs. Aren't CSAs relevant?

Initial distribution for CUAs/ CSAs p. 40: We suggest that the agency clarify this discussion. Also, the claim of environmental benefit is suspect. p. 49: Does EPA have the authority for " pay as you bid" auction? p. 50: The discussion on two auctions a year is not clear. Why is a two auction per year approach necessary? Is this true for allocation, too?

1% Discount EPA would impose a 1% tax on trades of CUAs. Does this apply to all trades or just the first trade? Does this tax apply to trade of CSAs? Is the 1% tax applied in all cases? Any other examples ( p. 41)? Is there a legal basis for going lower?

Baseline p. 22: We suggest that the agency ask for comment on the magnitude of burden in adjusting the baseline and whether people want to do this.

B/ C analysis The magnitude of the benefits: 20 30 million annually. EPA should note that the market price for some agricultural commodities not reflective of opportunity cost, and provide other relevant caveats. Also, we suggest that the agency delineate the sources of benefits and costs clearly. The agency should specify # of years when presenting PV estimates. Are Options 2 and 3 still relevant?

Reg Text p. 62: There is no transfer language for CUA/ CSA holders. This seems inconsistent with the preamble language.

PRA p. 24: Has EPA satisfied the PRA in its section 114 survey for existing stocks?

Penalty p. 44: Please add text indicating that any penalty should reflect the economic benefit/ advantage of the violation. p. 44: "  deter them from simply incorporating the penalty ( and the mis use of exempted methyl bromide) into their business plans." Although theoretically possible, how likely is this scenario?

EO 13045 p. 60: EO 13045 does not apply since this isn't a major/ economically significant rule.


       Support for OSHA's Preliminary Economic Analysis for the Proposed Beryllium Standard:
             Excel Spreadsheets of Economic Costs, Impacts, and Benefits

The attachments to this exhibit are Excel (spreadsheet) workbooks that contain data and analysis supporting OSHA's preliminary economic analysis (PEA) of the proposed beryllium standard. Below is a brief description of each workbook.
Beryllium PEA Excel Workbook #1: New BE Costs21.xlsx - Cost spreadsheet for the main proposal, including impact estimates; estimates, by NAICS industry code, of the numbers of establishments, entities, and employees affected by the proposed standard; the distribution of worker exposures; and other industrial and financial characteristics of affected industries. Includes first tab "TOC" (Table of Contents), which describes all other tabs in the spreadsheet.
Beryllium PEA Excel Workbook #2: New Benefits6.xlsx  -  Main benefit calculation spreadsheet. Includes first tab "TOC" (Table of Contents), which describes all other tabs in the spreadsheet.
Beryllium PEA Excel Workbook #3: Benefits_tables.xlsx  -  Benefit tables for presentation based on spreadsheet New Benefits6.xlsx. Includes first tab "TOC" (Table of Contents), which describes all other tabs in the spreadsheet.
Beryllium PEA Excel Workbook #4: Alternative Benefit Model.xlsx  -  Calculation of the alternative benefit model presented in Chapter VII.  Includes first tab "Notes," which describes all other tabs in the spreadsheet.
Beryllium PEA Excel Workbook #5: Alternatives_Summary_061715.xlsx  -  Summary spreadsheet of all the regulatory alternatives presented in Chapter VIII.  Includes first tab "Notes," which discusses the spreadsheet mechanics of how the regulatory  alternatives were generated, and tab "Summary," which presents all numbers, including notes on estimation. The rest of the tabs contain various presentation tables.
These are the workbooks with detailed cost calculations for each individual regulatory alternative:
Beryllium PEA Excel Workbook #6: Alternative1a_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #7: Alternative1b_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #8: Alternative2a_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #9: Alternative2b_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #10: Alternative3_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #11: Alternative8_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #12: Alternative9_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #13: Alternative10_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #14: Alternative11_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #15: Alternative13_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #16: Alternative14_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #17: Alternative15_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #18: Alternative16_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #19: Alternative17_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #20: Alternative19_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #21: Alternative20_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #22: Alternative21a_New BE Costs21.xlsx,
Beryllium PEA Excel Workbook #23: Alternative21b_New BE Costs21.xlsx


                           SUPPORTING STATEMENT FOR
                    AN INFORMATION COLLECTION REQUEST (ICR)

Title of the Information Collection

	Title:	Recordkeeping Requirements for Producers of Pesticides 40 CFR Part 169
	EPA ICR No.:  0143.14
	OMB Control No.:  2070 - 0028
	Docket ID No.: EPA-HQ-OECA-2017-0640

Short Characterization/Abstract
This is a renewal of a currently approved Information Collection Request (ICR) that covers the information collection activities under the Recordkeeping Requirements for Producers found at 40 CFR part 169. These regulations issued under Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 8 state that the Administrator of the Environmental Protection Agency may prescribe regulations requiring pesticide producers, registrants, and applicants for registration to maintain such records with specifies the records that pesticide producers must keep and how to dispose of them. Under FIFRA section 8, producers must make such records available for inspection and copying.

Producers must maintain records on production data for pesticides, devices, or active ingredients (including pesticides produced pursuant to an experimental use permit); receipt by the producer of pesticides, devices, or active ingredients used in producing pesticides; delivery, moving, or holding of pesticides; inventory; domestic advertising for restricted use pesticides; guarantees; exports; disposal; human testing; and tolerance petitions. These records generally consist of the material produced during the course of ordinary business activity, and are maintained in the location, manner, and duration as is generally prudent for such records in the course of ordinary business activity.

Respondents are required to maintain records of receipt, production, shipping, and inventory for two years. Records regarding testing of registered pesticides must be maintained for the life of the pesticide registration, as such data are necessary to support the regulatory decision.

These records are subject to both call-in by EPA and on-site inspection by EPA and its representatives. EPA has not established a regular schedule for the collection of these records, there is no reporting. The businesses subject to the pesticide producer recordkeeping regulations includes producers of any pesticide, device or active ingredient as well as distributors, carriers and pesticide dealers. The records have to be maintained by the owners and operators of such businesses and made available to inspectors to ensure that businesses are in compliance with recordkeeping requirements. These inspections are generally conducted by the states, which enforce FIFRA regulations through cooperative agreements with EPA.

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

 The statutory authority for these collection activities is found in section 8 of FIFRA, 7 U.S.C. 136f. The pesticide producer recordkeeping regulations are contained in Title 40 of the Code of Federal Regulations (CFR) parts 169. See Attachments A and B.2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
EPA or its representative (i.e., the states) will use records that are required to be maintained to verify compliance with the regulations.  Although records maintained under the regulations are subject to call-in by EPA, the Agency does not expect to conduct routine call-ins. Instead, the records will be reviewed during routine establishment inspections. These inspections are generally conducted by the states, which enforce FIFRA regulations through cooperative agreements with EPA. In addition, the requirement to keep records may foster regulatory compliance because facilities know they could be inspected and would need to furnish the records.

FIFRA Section 8(a) states that the Administrator may prescribe regulations requiring producers, registrants, and applicants for registration to maintain such records with respect to their operations and the pesticides and devices produced as the Administrator determines are necessary for the effective enforcement of FIFRA and to make such records available for inspection and copying. FIFRA Section 12(a)(2)(B)(i) provides that it is unlawful for any person to refuse to prepare, maintain, or submit any records required by or under Section 8 of the Act.

EPA must be able to examine and copy records of pesticide producers demonstrating the identity, production, receipt, shipment, inventory, advertisement, and guarantees with respect to all domestically sold or distributed pesticides. This is necessary to determine that such products are in compliance with FIFRA and to support enforcement action against the products producers if they are not. EPA must be able to examine and copy records with respect to exported pesticides in order to determine that products that have been exported are in compliance with labeling and foreign purchaser specification and acknowledgment requirements, and to take enforcement action against exporters who do not comply with FIFRA requirements. EPA must be able to examine records of pesticide disposal in order to protect public health and the environment should it be necessary to locate such disposal sites. EPA must be able to access records regarding testing on humans to protect the health and safety of such testing subjects should potential adverse effects become known. EPA must be able to access records regarding testing of registered pesticides to determine the integrity of such information, and the subsequent validity of regulatory decisions based on such information that allow the continued sale and distribution of specific pesticide products. These data may be used by enforcement and compliance officers at the federal and state level, and by regulatory officials at the federal and state level.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

EPA does not collect any information under this information collection request. All information subject to this collection request is to be gathered and maintained by pesticide producers.

Producers determine how best to comply with the requirements for recordkeeping under 40 CFR part 169. They may collect and store the required data electronically. The Agency, through State, headquarters or EPA Regional inspectors, may periodically audit or review the data at sites chosen by individual producers. Other than review during periodic inspections, those records will generally not be submitted to the Agency unless the Agency requests them for a specific reason, such as a need to review research data supporting a registration or in the preparation of an enforcement case.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

Duplication is not an issue because these records are generally unique to the requirements of the federal pesticide law (FIFRA) and to specific pesticide products.  EPA is the primary Federal Agency that regulates pesticide producers. To the extent that companies may already retain these records as part of its management practices, any potential duplication will facilitate their compliance with the regulation. These records may be reproduced at the time of an inspection, but EPA does not require a producer to submit these records to the Agency. Therefore, there is no duplication of effort.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The information to be recorded is straightforward and can be maintained by facilities in the manner they see fit, as long as the records are available for review during routine establishment inspections by EPA or the states. The information collected under this ICR does not negatively impact small businesses, because the records required to be maintained are those which qualify as "customary and usual business activity." To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced. However, even though the recordkeeping and reporting requirements are the same for small and larger businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

Not applicable. There is no collection activity. Records are generated when certain activities take place, related to the production and distribution of pesticides and pesticidal devices, and, if necessary, information will be collected periodically without a set schedule for compliance assurance.

EPA must be able to examine and copy records at pesticide producers demonstrating the identity, production, receipt, shipment, inventory, advertisement, and guarantees with respect to all domestically sold or distributed pesticides. This is necessary to determine that such products are in compliance with FIFRA and to support enforcement action against the products producers if they are not. EPA must be able to examine and copy records with respect to exported pesticides in order to determine that products that have been exported are in compliance with labeling and foreign purchaser specification and acknowledgment requirements, and to take enforcement action against exporters who do not comply with FIFRA requirements. EPA must be able to examine records of pesticide disposal in order to protect public health and the environment should it be necessary to locate such disposal sites. EPA must be able to access records regarding testing on humans to protect the health and safety of such testing subjects should potential adverse effects become known. EPA must be able to access records regarding testing of registered pesticides to determine the integrity of such information, and the subsequent validity of regulatory decisions based on such information that allow the continued sale and distribution of specific pesticide products. These data may be used by enforcement and compliance officers at the federal and state level, and by regulatory officials at the federal and state level.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:
 requiring respondents to report information to the agency more often than quarterly;
 requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
 requiring respondents to submit more than an original and two copies of any document;
 requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
 in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
 requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
 that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
 requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

The only guideline established under the Paperwork Reduction Act (PRA) that may be exceeded in this collection is the time period for retaining records.  The PRA guidelines specify that an Agency must provide justification when requiring data other than health, medical or tax records be retained for more than three years. This is discussed below.

Each record required relates to a separate, discrete business activity. Each record is generated only once in the course of each activity. It would not be possible to reduce the collection frequency without removing certain activities from compliance altogether.

8. If applicable, provide a copy and identify the date and page number of publications in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

Prior to submission to OMB, this ICR was made available to the public for comment through a Federal Register notice. The public had 60 days to provide comments. EPA did receive one comment in response to the previously provided public review opportunity issued in the Federal Register on September 7, 2022 (87 FR 54,687).

Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval. In accordance with this regulation, EPA pursued additional consultations with interested parties during the development of the renewal of this collection.

EPA contacted the following pesticide companies with questions regarding the ICR:

 Kimberly York, Syngenta Crop Protection, LLC
 Tami Jones-Jefferson, Corteva Agriscience LLC
 Amanda Burwell, Stepan Company
 Dr. Nina Ellen Jenkins, Conidio Tec
 Jeff Stroburg, Southern States Cooperative, Inc.

The questions EPA asked included:

      1.	As part of this ICR renewal, EPA reassessed who typically preforms the activities necessary to comply with 40 CFR part 169. In previous ICR burden analysis, EPA assumed that most of the recordkeeping activities were performed by managers and clerical staff. For this renewal, EPA recognized that there may be four different types of employees involved in meeting the recordkeeping requirements. EPA assumes that Managers, Compliance Officers, Computer Technicians, and Data Entry staff help pesticide producers and distributors comply with 40 CFR part 169. What categories of staff help your company comply with 40 CFR part 169?
      2.	On the following activities, how long did you or staff spend on completing each of the following aspects associated with complying with 40 CFR part 169 -- Books and Records of Pesticide Production and Distribution?
      3.	Are there activities EPA is missing?
      4.	Would you like to mention anything specific to this issue in your experience, which was not asked in the survey?

EPA did not receive responses to the questions posed.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

This question is not applicable to this ICR.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a system of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

In some cases, the pesticide producer records may contain confidential business information (CBI) as defined in FIFRA, but the other records do not contain CBI. If the producers submit CBI, such information is protected from disclosure under FIFRA Section 10. CBI data submitted to the EPA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual.

Since EPA does not anticipate a collection or call-in of the retained records covered by this ICR, the information in those records would not leave the possession of the affected businesses.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

Not applicable. No information of a sensitive or private nature is requested in this information collection activity.

12. Provide estimates of the hour burden of the collection of information. The statement should:
 Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
 If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
 Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under `Annual Cost to Federal Government.'

The regulated community affected by the producer recordkeeping regulations includes businesses that produce, sell or distribute pesticide products or devices. The affected businesses are pesticide producers, classified as North American Industry Classification System (NAICS) AICS 3250A1 - Chemical Manufacturing (3251, 3252, 3253, and 3259 only),

The records that must be maintained for purposes of 40 CFR part 169 are generally those that a responsible company would maintain as good business practice. It is estimated that the burden for a producer to prepare for the possibility of an on-site EPA inspection of those records, is 1.75 hours per year. While an additional burden will fall upon a company undergoing an inspection to locate and present the records, a given company is unlikely to undergo an inspection more often than once every two to three years.

Approximately 19,027 respondents are currently subject to this requirement, and it is estimated that 808 additional respondents per year will become subject to this requirement in the next three years. The estimate of the number of respondents is based on the number of registered active pesticide producers, which defines the entire universe of legal producers of pesticides for sale or distribution in the United States. The estimated change is based on extrapolation from trends in the number of reported producers over the last five years. EPA considers the activities under this ICR to be customary business practices. EPA estimated the costs based on the limited activities needed to understand the regulations at 40 CFR part 169 and their integration into the producer's customary business practices.

The regulated community affected by the producer recordkeeping regulations includes businesses that produce, sell or distribute pesticide products or devices. This ICR uses estimates of labor rates and associated costs based on Department of Commerce Bureau of Labor Statistics estimates. Specifically, this ICR uses the May 2021 National Industry-Specific Occupational Employment and Wage Estimates for the North American Industry Classification System (NAICS) AICS 3250A1  --  Chemical Manufacturing (3251, 3252, 3253, and 3259 only). The mean hourly wage rates for NAICS code 3250A1 were: management, $69.64; compliance officer, $38.31; computer and mathematical operations, $44.71; and data entry and information processing workers, $17.30. A factor of 1.6 was added to adjust for benefit costs, resulting in respective total labor costs of $111.42, $61.30, 71.54, and $27.68.

                                   Activity
                    Management (11-000) Hours Per Response
                            Total Management Hours
                               Management Costs
                              Compliance Officer
                         (13-1041) Hours Per Response
                        Total Compliance Officer Hours
                           Compliance Officer Costs
                     Computer (15-000) Hours Per Response
                             Total Computer Hours
                                Computer Costs
                    Data Entry (43-9020) Hours Per Response
                               Total Data Hours
                               Data Entry Costs
                                  Total Hours
                                  Total Costs

                           at loaded hourly rate of:

                           at loaded hourly rate of:

                           at loaded hourly rate of:

                           at loaded hourly rate of:

                               $          111.42

                                $         61.30

                                  $     71.54

                                  $     27.68

a.  Read regulation
                                                                            0.1
                                                                          1,903
                                                              $        212,006
                                                                          0.40
                                                                          7,611
                                                                 $     466,512
                                                                              0
                                                                              0
                                                             $             -
                                                                              0
                                                                              0
                                                              $            -
                                                                       9,513.50
                                                                   $   678,518
                                                            Respondents: 19,027

b.  Develop recordkeeping system and procedures
                                                                           0.05
                                                                             40
                                                            $            4,502
                                                                          0.20
                                                                            162
                                                               $         9,905
                                                                           0.75
                                                                            606
                                                                    $   43,351
                                                                              0
                                                                              0
                                                              $            -
                                                                         808.00
                                                                  $     57,758
                                                               Respondents: 808

c.  Store, File, or Maintain the Information
                                                                              0
                                                                              0
                                                      $                    -
                                                                              0
                                                                              0
                                                          $                -
                                                                           0.05
                                                                            951
                                                                    $   68,056
                                                                            0.2
                                                                          3,805
                                                                     $ 105,333
                                                                       4,756.75
                                                                   $   173,389
                                                            Respondents: 19,027

                                                                         Total:
                                                                           0.15
                                                                          1,943
                                                                     $ 216,508
                                                                           0.60
                                                                          7,772
                                                                 $     476,417
                                                                           0.80
                                                                          1,557
                                                                     $ 111,407
                                                                           0.20
                                                                          3,805
                                                                     $ 105,333
                                                                         15,078
                                                                   $   909,665

13. Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
 If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
 Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

The only type of industry costs associated with complying with the ICR activity are labor costs. There are no capital/start-up or O&M costs.

14. Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

There is no direct cost to EPA. EPA or duly authorized state inspectors only collects this information as part of an inspection or other compliance monitoring activity. EPA does not anticipate collecting or calling-in the records retained to comply with the producer recordkeeping regulations. The data maintained by pesticide producers will be available for review by EPA or its designee to ensure compliance with the regulations during an inspection.

15. Explain the reasons for any program changes or adjustments reported on the burden worksheet (in hour or cost burden.)

There is a decrease of 42,054 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of our reassessment of the assumptions used to estimate the burden of this ICR. Adjustments resulted from corrections of clerical or computational errors in the previous ICR renewal supporting statement. Further adjustments to the burden estimates resulted from (1) adjustments in the salary computation for industry to reflect current wage scales; (2) adjustments for inflation; and (3) adjustment to the number of respondents.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

Not applicable. The activity is conducted only as needed by EPA or state inspections, or upon the determination of the respondent. There is no set schedule for the collection of this information.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

This question is not applicable to this ICR.

18.Explain each exception to the topics of the certification statement identified in "Certification for Paperwork Reduction Act Submissions."

EPA does not request an exception to the certification of this information collection.
 List of Attachments for this Supporting Statement
7 USC 136f
40 CFR 169
87 FR 54,687


Jackson County Wind Rose Analysis  2001 Wind Speed and Wind Direction on 4 Highest 8 hour Ozone Days Maximum 8 hour ozone concentration of 85 ppb Maximum 8 hour ozone concentration of 84 ppb Maximum 8 hour ozone concentration of 87 ppb Maximum 8 hour Ozone concentration of 84 ppb


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Pages 5327-5330]
[FR Doc No: 2013-01447]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2012-N-1238]

Medical Devices; Ophthalmic Devices; Classification of the
Scleral Plug

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to classify the scleral plug into class II (special controls), and
proposing to exempt the scleral plugs composed of surgical grade
stainless steel (with or without coating in gold, silver, or titanium)
from premarket notification (510(k)) and to continue to require
premarket notification (510(k)) for all other scleral plugs in order to
provide a reasonable assurance of safety and effectiveness of the
device. The scleral plug is a prescription device used to provide
temporary closure of a scleral incision during an ophthalmic surgical
procedure.

DATES: Submit either electronic or written comments by April 25, 2013.
See section IV of this document for the proposed effective date of a
final rule that may issue based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1238, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1238 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tina Kiang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory and Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(Pub. L. 101-629), the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115), among other amendments, established
a comprehensive system for the regulation of medical devices intended
for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the Agency takes the following steps: (1) Receives
a recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the FD&C Act (21
U.S.C. 360c(f)) into class III without any FDA rulemaking process.
These devices remain in class III and require premarket approval,
unless and until: (1) FDA reclassifies the device into class I or II;
(2) FDA issues an order classifying the device into class I or II in
accordance with section 513(f)(2) of the FD&C Act, as amended by FDAMA;
or (3) FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)),
to a predicate device that does not require premarket approval. The
Agency determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act and part 807 of the regulations (21 CFR
Part 807).
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. FDA has determined that premarket notification is not
necessary to assure the safety and effectiveness of scleral plugs if
the material is a surgical grade stainless steel with or without a
gold, silver, or titanium coating.

B. Regulatory History of the Device

    After the enactment of the Medical Device Amendments of 1976, FDA
commenced to identify and classify all preamendments devices, in
accordance with section 513(b) (21 U.S.C. 360c(b)) of the FD&C Act. In
the Federal Register of September 2, 1987 (52 FR 33346), FDA classified
a total of 109 generic types of ophthalmic devices. The scleral plug
was not identified in this initial effort. FDA has regulated scleral
plugs as devices requiring premarket notification (510(k)). Scleral
plugs currently on the market have been determined to be substantially
equivalent to devices that were in commercial distribution prior to May
28, 1976. Currently, FDA regulates scleral plugs as devices requiring
premarket notification (510(k)). There have been ten 510(k) submissions
received and cleared under product code LXP (scleral plugs).
    Consistent with the FD&C Act and the regulations, FDA consulted
with the Ophthalmic Devices Panel (the Panel), an FDA advisory
committee, regarding

the classification of this device type on January 22, 1996 (Ref. 1). At
the panel meeting, the Panel recommended scleral plugs as
classification as class I, 510(k) exempt. Two 510(k) submissions have
been cleared since the panel meeting.

II. Recommendation of the Panel

    During a public meeting which was held on January 22, 1996, the
Panel made recommendations regarding the classification and regulatory
controls for the scleral plug. FDA is proposing the following
identification based on the Panel's recommendations and the Agency's
review:

A. Identification

    A scleral plug is a prescription device intended to provide
temporary closure of a scleral incision during an ophthalmic surgical
procedure. These plugs prevent intraocular fluid and pressure loss when
instruments are withdrawn from the eye. Scleral plugs include a head
portion remaining above the sclera, which can be gripped for insertion
and removal, and a shaft that fits inside the scleral incision. Scleral
plugs are removed before completing the surgery. Therefore, they are
generally only used in operating rooms. These devices are often made of
surgical grade stainless steel and can be coated in gold, silver, or
titanium.
    Scleral plugs have a long and established history of clinical use.
They are routinely used in many ophthalmic surgeries (specifically,
vitreoretinal surgeries). One common type of vitreoretinal surgery is
vitrectomy. Vitrectomy is estimated to be the third most frequently
performed ophthalmic surgical operation, after cataract and excimer
laser refractive surgery (Ref. 2). Approximately 225,000 vitrectomies
are done in the United States each year (Ref. 2).

B. Recommended Classification of the Panel

    Although the Panel was informed that scleral plugs have
historically been treated as class II devices, the Panel recommended
that a scleral plug made of a material previously used in legally
marketed devices be classified into class I (general controls) and be
exempt from premarket notification because the biocompatibility and
ability to be sterilized have already been established. The Panel's
rationale for suggesting that the scleral plug be classified into class
I was because general controls would provide reasonable assurance of
the safety and effectiveness of the device type if it is made from a
material established to be readily sterilized and biocompatible. During
the panel discussion, a distinction was made that scleral plugs
consisting of other materials (i.e., materials that are not already
included in legally marketed medical devices to the date of the
classification regulation) should be classified into class II and
require biocompatibility testing as a special control.
    As a result of the distinction between materials used for this
device, the Panel recommended that, unless new materials are proposed,
the device should be exempt from premarket notification.

C. Summary of Reasons for Recommendation

    The Panel considered FDA's extensive regulatory experience with the
device type and the Panel members' personal knowledge of and clinical
experience with the device type. The Panel also considered the long
history of safety and effectiveness of the device over many years of
clinical use. The Panel recommended that the scleral plug be classified
into class I because it concluded that general controls would provide
reasonable assurance of the safety and effectiveness of the device type
if it was made from a material established to be readily sterilized and
biocompatible. The Panel also recommended that scleral plugs be exempt
from premarket notification requirements if the proposed device does
not introduce new materials (i.e., materials that are not established
to be safe for this type of application).
    However, FDA believes that a class II classification is appropriate
and consistent with the intent of the Panel to establish requirements
(such as biocompatibility and sterility) for these devices. Although
the Panel identified potential risks and the measures that could be
taken to mitigate these risks, the Panel's recommendation of class I
would not permit FDA to establish as special controls the mitigation
measures discussed (biocompatibility, sterility). Therefore, while FDA
is not adopting the Panel's recommendation of classification into class
I, the Agency agrees with the concerns and mitigation measures
discussed by the Panel that would support a classification under class
II.

D. Risks to Health

    Based on the Panel's discussion and recommendations and FDA's
experience with the device, the risks to health associated with the
scleral plugs made from surgical grade stainless steel with or without
gold, silver, or titanium coating and the proposed measures to mitigate
these risks are identified in table 1 of this document.

 Table 1--Health Risks and Mitigation Measures for the Scleral Plug Made
                   From Surgical Grade Stainless Steel
          [With or without a gold, silver, or titanium coating]
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility Testing.
Adverse Tissue Reaction...................  Biocompatibility Testing.
Loss, breakage, or migration of the plug..  Labeling.
------------------------------------------------------------------------

    For scleral plugs that are made of surgical grade stainless steel
(with or without a gold, silver, or titanium coating) the following
special controls, in addition to general controls, can address the
risks to health in table 1 of this document and provide reasonable
assurance of safety and effectiveness of the device: (1) Performance
data must demonstrate the sterility and shelf life of the device; (2)
the device must be demonstrated to be biocompatible; and (3) labeling
must include all information required for the safe and effective use of
the device, including specific instructions regarding the proper
incision size, placement, and removal of the device.
    Because of the varying properties of other materials and the
potential impact on safety and effectiveness, FDA has identified
additional special controls for devices made of materials other than
surgical grade stainless steel. Based on the Panel's discussion and
recommendations and FDA's experience with the device, the risks to
health associated with the scleral plugs made from materials other than
surgical grade stainless steel and the proposed measures to mitigate
these risks are identified in table 2 of this document.

  Table 2--Health Risks and Mitigation Measures for Scleral Plugs Made
        From Materials Other than Surgical Grade Stainless Steel
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility Testing.
                                            Shelf-life Testing.
Adverse Tissue Reaction...................  Biocompatibility testing.
                                            Material characterization.
                                            Performance testing to
                                             determine the level of
                                             extractables.

Loss, breakage, or migration of the plug..  Material characterization.
                                            Performance testing for
                                             Mechanical Properties.
                                            Labeling.
------------------------------------------------------------------------

    The Agency believes that the following special controls, in
addition to general controls, will provide reasonable assurance of
safety and effectiveness for scleral plugs that are composed of a
material other than surgical grade stainless steel, as outlined in
table 2: (1) Performance data must demonstrate the sterility and shelf
life of the device; (2) the device must be demonstrated to be
biocompatible; (3) characterization of the device materials must be
performed; (4) performance data must demonstrate acceptable mechanical
properties under simulated clinical use conditions including insertion
and removal of the device; (5) performance data must demonstrate
adequately low levels of the extractables or residues from
manufacturing (or processing) of the device; and (6) labeling must
include all information required for the safe and effective use of the
device, including specific instructions regarding the proper incision
size, placement, and removal of the device. In addition, the scleral
plug is a prescription device and must be used in accordance with 21
CFR 801.109.

III. Proposed Classification and FDA's Finding

    Adverse events involving scleral plugs are rare, as evidenced by
the fact that FDA identified only a single adverse event in our
reporting systems and two adverse events in the published literature
(Refs. 3 and 4). The one adverse event reported to FDA resulted in no
persistent adverse effects to the patient and, according to the report,
this specific type of non-metallic scleral plug was discontinued and
replaced with surgical grade stainless steel scleral plugs.
    FDA believes that a class II classification is consistent with the
intent of the Panel to establish requirements (such as biocompatibility
and sterility) for these devices. The identified special controls
mitigate the known risks of the device that were identified by the
Panel. However, the FDA does not agree with the Panel that all
materials included in legally marketed scleral devices can be exempted
from 510(k) due to the potential for safety concerns in some materials
that will require specific material information and performance data to
provide a reasonable assurance of safety and effectiveness. FDA
believes this type of information should be reviewed by FDA prior to a
device being marketed in the United States.
    FDA proposes the scleral plug be classified into class II. The
special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device. FDA
also agrees, in part, with the Panel's recommendation that premarket
notification is not necessary to assure the safety and effectiveness of
scleral plugs if new materials are not introduced and, therefore, the
Agency is giving notice of intent to exempt the scleral plug device
from premarket notification requirements if the device is made from
surgical grade stainless steel (with or without a gold, silver, or
titanium coating).

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and Executive Order 13563, the Regulatory Flexibility Act
(5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed regulation will classify a
previously unclassified pre-Amendment device type, there are only five
registered establishments listed in the Establishment Registration and
Device Listing database, and the proposed regulation designating the
classification of scleral plugs as class II is consistent with the
historical regulatory oversight given to this device type, the Agency
proposes to certify that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The proposed rule would impact current manufacturers if they were
to make changes to their existing products and any manufacture wanting
to market a new scleral plug. If the new or changed product is made of
surgical grade stainless steel with or without gold, silver, or
titanium coating, manufacturers could begin marketing after they
complied with the proposed special controls. They would not need to
submit an application to the Agency for preapproval. There would be no
change from current requirements for new products made of alternative
materials; they would need premarket notification before marketing.

VII. Paperwork Reduction Act of 1995

    This proposed rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 801 have been
approved under OMB control

number 0910-0485; the collections of information in 21 CFR part 807
have been approved under OMB control number 0910-0387.

VIII. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday and
are available electronically at http://www.regulations.gov. (FDA has
verified the Web site addresses of the following references, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

    1. Transcript from the Food and Drug Administration Ophthalmic
Devices Panel Meeting, January 22, 1996.
    2. Chang, Stanley, ``LXII Edward Jackson Lecture: Open Angle
Glaucoma After Vitrectomy,'' American Journal of Ophthalmology, vol.
141(6): pp. 1033-1043, June 2006, available at http://www.sciencedirect.com/science/article/pii/S0002939406002546.
    3. Stewart, M. W., ``Intraoperative Radiographic Detection of a
`Lost' Scleral Plug,'' Retina, vol. 25(4): pp. 526-527, June 2005.
    4. Bovino, J. A. and D. F. Marcus, ``Intraocular Foreign-Body
Hazard During Vitrectomy,'' American Journal of Ophthalmology, vol.
93 (3): p. 366, March 1982.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend part 886 as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. In subpart E, add Sec.  886.4155 to read as follows:

Sec.  886.4155  Scleral plug.

    (a) Identification. A scleral plug is a prescription device
intended to provide temporary closure of a scleral incision during an
ophthalmic surgical procedure. These plugs prevent intraocular fluid
and pressure loss when instruments are withdrawn from the eye. Scleral
plugs include a head portion remaining above the sclera, which can be
gripped for insertion and removal, and a shaft that fits inside the
scleral incision. Scleral plugs are removed before completing the
surgery.
    (b) Classification. Class II (special controls). The special
controls for the scleral plug are:
    (1) The device is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to the limitations in
Sec.  886.9 if the material is a surgical grade stainless steel with or
without a gold, silver, or titanium coating. The special controls for
the surgical grade stainless steel scleral plug (with or without a
gold, silver, or titanium coating) are:
    (i) The device must be demonstrated to be sterile during the
labeled shelf life;
    (ii) The device must be demonstrated to be biocompatible; and
    (iii) Labeling must include all information required for the safe
and effective use of the device, including specific instructions
regarding the proper sizing, placement, and removal of the device.
    (2) The device is not exempt from premarket notification procedures
if it is composed of a material other than surgical grade stainless
steel (with or without a gold, silver, or titanium coating). The
special controls for scleral plugs made of other materials are:
    (i) The device must be demonstrated to be sterile during the
labeled shelf life;
    (ii) The device must be demonstrated to be biocompatible;
    (iii) Characterization of the device materials must be performed;
    (iv) Performance data must demonstrate acceptable mechanical
properties under simulated clinical use conditions including insertion
and removal of the device;
    (v) Performance data must demonstrate adequately low levels of the
extractables or residues from manufacturing (or processing) of the
device; and
    (vi) Labeling must include all information required for the safe
and effective use of the device, including specific instructions
regarding the proper sizing, placement, and removal of the device.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01447 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10505-10506]
[FR Doc No: 2023-03462]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-41-000]

Viking Gas Transmission Company; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on January 30, 2023, Viking Gas Transmission
Company (Viking), 100 West 5th Street, Tulsa, Oklahoma 74105, filed a
prior notice request pursuant to 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. CP82-414-000 requesting
authorization to construct its Viking Project--Line MNG2207B-100.
Specifically, Viking proposes to install a new 2,500 horsepower gas-
fired reciprocating compressor unit at its Angus Compressor Station in
Polk County, Minnesota. The Project is designed to transport up to
30,000 dekatherms per day of incremental firm transportation service to
an existing delivery point in Fargo, North Dakota. Viking estimates the
cost of the project to be $11,381,461, all as more fully set forth in
the request which is on file with the Commission and open to public
inspection.
    Any questions concerning this request should be directed to Denise
Adams, Director, Regulatory Affairs, Viking Gas Transmission Company,
100 West 5th Street, ONEOK Plaza, Tulsa, Oklahoma, by telephone at
(918) 732-1408 or by email at [email protected].
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on April 10, 2023.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is April 10, 2023. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
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    \3\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is April 10, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the

intervention deadline are untimely and may be denied. Any late-filed
motion to intervene must show good cause for being late and must
explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before April 10, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-41-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing.'' The Commission's eFiling
staff are available to assist you at<PHONE_NUMBER> or
[email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP23-41-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Denise Adams,
Director, Regulatory Affairs, Viking Gas Transmission Company, 100 West
5th Street, ONEOK Plaza, Tulsa, Oklahoma, by telephone at (918) 732-
1408 or by email at [email protected].
    Any subsequent submissions by an intervenor must be served on the
applicant and all other parties to the proceeding. Contact information
for parties can be downloaded from the service list at the eService
link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: February 9, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-03462 Filed 2-17-23; 8:45 am]
BILLING CODE 6717-01-P


< Facility ID>

U. S. EPA Aquatic Animal Production Industry Screener Survey c/ o [ undetermined] at Westat 1650 Research Blvd. Rockville, MD 20850 < Facility> < Address> < City, State Zip>

Dear < Name>,

The U. S. Environmental Protection Agency ( EPA) is conducting a two part survey of the aquatic animal production ( aquaculture) industry as part of its effort to develop effluent limitations guidelines and standards for this industry. The two parts of this survey effort consist of a short screener questionnaire ( attached) that is being sent to a large number of farms/ facilities in the industry and a more detailed questionnaire that will be mailed at a later date to a sample of facilities. Response to this survey is required by law, Section 308 of the Clean Water Act ( Federal Water Pollution Control Act, 33 U. S. C. Section 1318). Please return the survey to the EPA within 15 days of receiving it.

You may claim the information included in the response to a question as confidential by checking the Confidential Business Information ( CBI) box next the question number. Please note that you may be required to justify any claim of confidentiality at a later time. Information covered by a claim of confidentiality will be disclosed by EPA only to the extent, and by means of, the procedures set forth in 40 CFR Part 2, Subpart B. In general, submitted information protected by a CBI claim may be disclosed to other employees, officers, or authorized representatives of the United States concerned with implementing the Clean Water Act.

Information covered by a claim of confidentiality will be made available to EPA contractors and subcontractors under EPA Contract Numbers 68 C 99 263, 68 C 99 233, 68 C 99 242 and 68 C6 0022 to enable the contractors to perform the work required by their contracts with EPA. All EPA contracts provide that contractor employees will use the information only for the purpose of performing the work required by their contracts and will not disclose any CBI to anyone other than EPA without prior written approval from each affected business or from EPA's legal office. Any comments you may wish to make on this issue must be submitted in writing along with your completed survey.

Please take a few minutes to complete and return this questionnaire. If you need help, call our Aquaculture Survey Helpline at the toll free number 1 888 733 1449. Thank you for your cooperation.

Sincerely,

Geoffrey H. Grubbs, Director Office of Science and Technology FORM APPROVED { OMB CONTROL NO. XXXX  XXXX { EXPIRATION DATE: XX/ XX/ XX Screener Questionnaire for the Aquatic Animal Production Industry May 2001 U. S. Environmental Protection Agency ( EPA) Office of Wastewater Management Washington, DC Notice of Estimated Burden EPA estimates that completion of the entire Screener Questionnaire for the Aquatic Animal Production Industry will require an average of 1 hour per facility. This estimate includes time for reading the instructions and reviewing the information necessary to respond to the questionnaire form. Any comments regarding EPA's need for the information, the accuracy of the provided burden estimate, and suggested methods for reducing respondent burden ( including the use of automated collection techniques) should be addressed to: Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW, Washington, DC 20460. Please include the OMB Control Number, listed in the left hand margin on this page, with any correspondence. Do not send the completed survey to this address. < Facility ID>

EPA Screener Questionnaire for the Aquatic Animal Production Industry 1. Do you produce ( grow) aquatic animals ( fish, shellfish, other aquatic animals) at this facility? ( Check one box)

* Yes. Complete the survey. Sign the Certification, and return the survey.

* No. Go to the last page. Sign the Certification and return the survey.

2. Is the mailing address on the label on the envelope correct? ( Check one box)

* Yes, the mailing address is correct.

* No, the mailing address is not correct. Please correct below.

Name of Facility: __________________________________________________

Mailing address or P. O. box: ________________________________________

City: ___________________________ State: _______ Zip: ___________

Contact name/ title: ________________________________________________

Telephone number: ( ) ________________________

* CBI 3. Is the name and address of the company, entity, or proprietor that owns this facility the same as that listed on the mailing label? ( Check one box)

* Yes, the owner's mailing address is the same. ( Please skip to question 4)

* No, the owner's mailing address is different than the above address. ( Please complete the owner's mailing address below.)

Name of company: ________________________________________________

Mailing address or P. O. box: ________________________________________

City: ______________________________ State: _____ Zip: __________

* CBI 4. Which corporation type best describes this company or entity? ( Check one box)

Corporation ( C Corporation) . . . . . . . . . . . . . . . . . . . . . . . . . . * Subchapter S Corporation/ Limited Liability Corporation . . . . . * Limited partnership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * General partnership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Sole proprietor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Federal hatchery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * State hatchery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Tribal hatchery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * Research facility ( e. g., university) . . . . . . . . . . . . . . . . . . . . . . * Other ( please describe below) . . . . . . . . . . . . . . . . . . . . . . . . . * Other: ________________________________________________ < Facility ID> COPY # ___ of ___

* CBI 5. Please complete the following table. Starting at line 1, use a separate line for each size category of species you produced in 2000. Please enter the appropriate code number from the table headings in each column. Refer to the footnotes for clarification on the different species codes provided. If you enter " Other" for any of the codes, please provide additional descriptive information. If additional spaces are required, photocopy this page before writing on it and label each copy in the space provided at the top left corner of the page.

Species Size Category Total Produced in Year 2000 Units 1 Catfish 2 Trout 3 Salmon 4 Striped Bass1 5 Tilapia 6 Other Finfish2 7 Baitfish3 8 Ornamentals4 9 Shrimp 10 Crawfish 11 Other Crustaceans5 12 Molluscan shellfish 1 Foodsize ( over 3/ 4 pound per fish) 2 Stockers ( over 6 inches or 60 750 lb/ 1000 fish) 3 Fingerlings ( 2 6 inches or 2 60 lb/ 1000 fish) 4 Fry ( under 2 inches or less than 2 lb/ 1000 fish) 5 Eggs 6 Seed Stock 7 Brood Stock ( used for breeding) 8 Other ( Please describe) 1 Pounds ( Live Weight) 2 Number or Count 3 Live Dry Bushels 4 Dozens 5 Dollars sold 6 Other ( Please describe)

13 Other6 ( Please describe)

Example 4 1 15,000 1 Example 4 2 10,000 1 1 2 3 4 5 6 1 Striped bass includes hybrid striped bass 4 Ornamentals include koi, ornamental goldfish, and tropical fish. 2 Other finfish include other food fish, sport/ game fish, etc. 5 Other crustaceans include lobster pounds, softshell crabs, etc 3 Bait fish include fathead minnows, golden shiners, feeder goldfish, etc. 6 Other includes anything that does not fit in the above categories; e. g. alligators, turtles, frogs, etc. Please describe.

* CBI 6. What methods of production do you use at this facility? ( Check Yes or No for each)

YES NO Ponds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * * Flow through raceways, ponds, or tanks . . . . . . . . . . . . . . . . . * * Recirculating systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * * Net pens or cages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . * * Floating aquaculture or bottom culture . . . . . . . . . . . . . . . . . . * * Other ( please describe below). . . . . . . . . . . . . . . . . . . . . . . . . * * _ _________________________________________________________

* CBI 7. Does water from your aquaculture facility leave your property? ( Check one box)

* Yes. Go to questions 8 and 9. Sign the certification and return * No. Skip questions 8 and 9. Sign the certification and return < Facility ID>

* CBI 8. Does any of this water go to a publicly owned treatment works ( POTW)?

* Yes.

* No.

* CBI 9. What pollutant control practices do you use before water leaves your property? ( For example, quiescent zones, off line or full flow settling basins, water level management, feed management, using vegetated ditches, proper siting practices, etc.) Please be as specific as possible. _______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

CERTIFICATION STATEMENT I certify under penalty of law that the enclosed survey response was prepared under my direction or supervision in accordance with a system designed to ensure that qualified personnel properly gathered and evaluated the information submitted. The information submitted is, to the best of my knowledge and belief, accurate and complete. In those cases where we did not possess the requested information, we provided best estimates in response to the questions. We have, to the best of our ability, indicated what we believe to be company confidential business information as defined under 40 CFR Part 2, Subpart B. We understand that we may be required at a later time to justify our claim in detail with respect to each item claimed confidential. I am aware that there are significant penalties for submitting false information, including the possibility of fines and imprisonment as explained in Section 308 of the Clean Water Act.

Signature of Certifying Official_______________________________ Date______________________

Printed Name of Certifying Official ___________________________ Telephone Number________________________

Title of Certifying Official___________________________________

Please return survey with signed certification statement to:

U. S. EPA Aquatic Animal Production Industry Screener Survey c/ o [ undetermined] at Westat 1650 Research Blvd. Rockville, MD 20850