1 SUPPORTING STATEMENT FOR STANDARD FORM 83 I PART A OF THE SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) TITLE AND NUMBER OF THE INFORMATION COLLECTION Modification of Anti Dumping Baselines for Gasoline Produced or Imported for Use in Hawaii, Alaska and U. S. Territories. Current OMB control number is 2060 0277. The EPA number for these modifications is 1591.17.

( b) SHORT CHARACTERIZATION/ ABSTRACT Section 211( k) of the Clean Air Act (" Act") mandates that reformulated gasoline ( RFG) which meets various requirements be exclusively sold in nine statutory control areas and in other ozone nonattainment areas that " opt in" to the reformulated gasoline program. The Act also requires EPA to regulate the production and sale of conventional gasoline ( non RFG) throughout the rest of the country. Refiners and importers of gasoline are required to demonstrate compliance by conducting sampling and testing of the gasoline and reporting the results to EPA's Office of Transportation and Air Quality. The burden and cost estimates in this ICR are those costs associated with modifications to the final rule establishing standards and requirements for reformulated and conventional gasoline pursuant to § 211( k) of the Act. Previous ICRs have covered start up costs and other record keeping, reporting, and testing requirements associated with the final rule.

This proposed rule would modify the RFG regulations to allow refiners and importers of gasoline intended for sale in Hawaii, Alaska, The Commonwealth of Puerto Rico and The Virgin Islands to change their compliance calculation method for purposes of demonstrating compliance with the requirements for conventional gasoline. Specifically, this rule would provide an alternative compliance method for refiners and importers who, under the current regulations, are required to produce or import gasoline that is actually cleaner than that required under the Clean Air Act. The rule would lower compliance costs and provide greater flexibility for the affected parties without compromising the environmental goals of the RFG/ anti dumping program. Today's rule would require very modest recordkeeping and reporting requirements for those parties who choose to change their compliance calculation method in accordance with this rule. Specifically, refiners and importers would be required to submit a petition to EPA requesting this change and they would be required to retain records which show that the gasoline was produced or imported for use in one of the affected areas.

2. NEED FOR AND USE OF THE COLLECTION ( a) NEED/ AUTHORITY FOR THE COLLECTION 2 The basic need and authority for the collection of information have been established in the ICR for the RFG final rule. The Act specifically provides that recordkeeping and reporting requirements are among the tools EPA may use in enforcement of the provisions of § 211( k) and also provides that EPA must develop an enforceable scheme. Sections 114 and 208 of the Act authorize EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the Act. The additional information collection required in this modification to the RFG final rule is necessary to ensure that sources comply with the standards and limitations of the rules for conventional gasoline.

( b) PRACTICAL UTILITY/ USERS OF THE DATA The practical utility and use of the collection of information under the RFG rule generally have been established in the ICR for the RFG final rule.

The information collection requirements associated with the provisions in this proposed rule are necessary enforcement mechanisms to monitor compliance with the regulations for conventional gasoline.

The EPA's Office of Enforcement and Compliance Assurance and EPA's Office of Air and Radiation, Office of Transportation and Air Quality, will be the governmental users of the information contained in this information collection.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA ( a) NONDUPLICATION The information collection is not unnecessarily duplicative of information otherwise reasonably accessible to the Agency and is not available from other sources. The type of collection activities associated with this modification to the RFG rule are approved under the ICR for the final RFG rule.

( b) PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB Notice of the proposed information collection changes to the RFG regulations resulting from this rulemaking is included in the preamble to the Notice of Proposed Rulemaking.

( c) CONSULTATIONS Representatives from the affected industry participated in the development of the provisions in this rule.

Public comments on this action will be addressed in the final rulemaking package. 3 ( d) EFFECTS OF LESS FREQUENT COLLECTION If the relevant information were collected less frequently, EPA would not be reasonably assured that the refiner or importer is in compliance with the standards for RFG and conventional gasoline.

( e) GENERAL GUIDELINES The general guidelines for the collection of information pursuant to the RFG rule are approved in the ICR for the final RFG rule.

( f) CONFIDENTIALITY AND SENSITIVE QUESTIONS ( i) Confidentiality Any information submitted to EPA for which a claim of confidentiality is made will be safeguarded according to EPA regulations at 40 C. F. R. 2.201 et. seq.

( ii) Sensitive Questions This section is not applicable as this ICR does not involve matters of a sensitive nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED ( a) RESPONDENTS/ SIC CODES Respondents are refiners ( 2911) and importers ( 5172) of conventional gasoline. The information required to be retained is generated and currently maintained by refiners and importers in the normal course of business. Without the required information, EPA would be unable to ensure compliance with the conventional gasoline requirements. The information collection required to be submitted in the petition under this rule is necessary for EPA to approve the respondent's change in compliance calculation method.

( b) INFORMATION REQUESTED ( i) Data Items, Including Record keeping Requirements Refiners and importers who choose to change their compliance calculation method in accordance with the provisions of this rule would be required to submit a one time petition to EPA requesting the change. In addition, the respondent would be required to retain records which indicate that the gasoline produced or imported was intended for use in one of the affected areas. 4 ( ii) Respondent Activities The information collection activities for recordkeeping and reporting, in general, are as described in the approved ICR for the RFG final rule. The activities associated with this rule change include a one time petition requesting the change in compliance calculation method, and retention of business records which establish that the gasoline was intended for use in one of the affected areas.

5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT ( a) AGENCY ACTIVITIES The burden on the Agency will increase only slightly as a result of this rule. The Agency will be required to review petitions submitted under the rule.

( b) COLLECTION METHODOLOGY AND MANAGEMENT There are no significant changes to the collection methodologies in the ICR for the RFG final rule anticipated as a result of this modification to the rule.

( c) SMALL BUSINESS FLEXIBILITY This action corrects certain inconsistencies in the regulations which currently may have a negative impact on some small business refiners and importers who produce or import gasoline for use in the affected areas. The rule also provides flexibility for these refiners and importers.

( d) COLLECTION SCHEDULE The collection schedule contained in the ICR for the RFG final rule would apply to the information collection in this proposed modification.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION ( a) ESTIMATING RESPONDENT BURDEN Three labor categories are involved with this rulemaking: managerial ( includes legal and professional review), technical, and clerical. The labor mix for each hour for the activity in this ICR is assumed to be about 0.10 hours managerial, 0.70 hours technical, and 0.20 hours clerical.

The increased recordkeeping/ reporting burden on refiners and importers who choose to petition EPA under this rule is estimated to be minimal. EPA estimates that 20 hours would be spent on each petition and that a total of 10 petitions would be submitted industry wide. The 5 recordkeeping requirement associated with this rule is expected to result in no additional burden, as the information required is generally included in business documents normally retained by refiners and importers.

( b) ESTIMATING RESPONDENT COST Employer costs associated with this ICR are estimated to be:

Managerial $ 86 per hour Technical $ 64 per hour Clerical $ 38 per hour Assuming this labor mix for the information collection activity described above, this gives an average labor cost of about $ 60 per hour for the activity associated with this rulemaking. The cost of submitting a petition under this rule would be $ 1,200 per respondent.

There are no capital/ start up costs associated with this information collection.

( c) ESTIMATING AGENCY BURDEN AND COST Insignificant additional Agency costs are anticipated with regard to this rule.

( d) ESTIMATING THE RESPONDENT UNIVERSE AND TOTAL BURDEN AND COSTS The total annual information collection burden on industry associated with this rule is estimated to be 200 hours. The total annual respondent cost associated with this rule is estimated to be $ 12,000.

( e) BOTTOM LINE BURDEN HOURS AND COSTS The bottom line burden hours and costs for the respondents is given in the table below:

TABLE 1. Refiner/ Importer Information Collection Information Collection Activity Mgr. Hr/ Yr ($ 86/ hr) Tech. Hr/ Yr ($ 64/ hr) Cler. Hr/ Yr ($ 38/ hr) Resp. Hr/ Yr Resp. Cost/ Yr Capital Startup Cost O& M Cost No. of Resp. Total Hr/ Yr Total Cost/ Yr Petition EPA 2.0 14.0 4.0 20.0 $ 1,200 0 N/ A 10 200 $ 12,000 ( f) REASON FOR CHANGE IN BURDEN 6 These changes to the existing ICR for the RFG final rule are necessary to provide the option afforded to refiners and importers under this rule and to provide adequate enforcement tools. The analysis in previous sections outlines as necessary the changes from the current ICR.

( g) BURDEN STATEMENT The annual public reporting and recordkeeping burden for this collection of information is estimated to average 20 hours per response, and $ 1,200 per respondent, for preparing a petition to submit to EPA.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OAR 2003 0010, which is available for public viewing at the Air and Radiation Docket and Information Center, in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Air Docket is ( 202) 566 1742. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ( OAR 2003 0010) in any correspondence. 7 B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS This section is not applicable because statistical methods are not used in the data collection associated with the reformulated and anti dumping regulations.


[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70119-70120]
[FR Doc No: 2016-24459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4012]

Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending
Request; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Sunscreen
Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This
guidance provides recommendations for the process for withdrawing a
586A request submitted under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and
withdrawing a pending request, as defined by the SIA. The
recommendations in this guidance apply to 586A requests and pending
requests that seek a determination from FDA of whether a
nonprescription sunscreen active ingredient, or a combination of
nonprescription sunscreen active ingredients, is generally recognized
as safe and effective (GRASE) for use under specified conditions and
should be included in the over-the-counter (OTC) sunscreen drug
monograph. We are issuing this guidance under the SIA, which directs
FDA to issue guidance on various topics, including guidance on the
process by which a request under section 586A or a pending request is
withdrawn. This guidance finalizes the draft guidance issued on
November 23, 2015.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-4012 for ``Sunscreen Innovation Act; Withdrawal of a 586A
Request or Pending Request.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240-402-
4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Sunscreen Innovation Act; Withdrawal of a 586A Request or
Pending Request.'' This guidance provides background information on the
sunscreen OTC monograph process and the new procedures under the SIA
(21 U.S.C. 360fff), for reviewing 586A requests (requests made under
section 586A of the FD&C Act (21 U.S.C. 360fff-1)) and pending requests
for nonprescription sunscreen active ingredients (the SIA process).
This guidance provides recommendations for the general withdrawal
process for 586A requests and pending requests. At certain stages of
the SIA process, a sponsor who submitted the 586A request or pending
request might seek to have it withdrawn, or a request may be withdrawn
due to the sponsor's failure to act on the request and failure to
respond to communications from FDA. This guidance addresses the
expected effect of a withdrawal on key phases of the SIA process,
including withdrawals made prior to or after the initial eligibility
determination, the submission of safety and efficacy data, the filing
determination, or the GRASE determination. This guidance also discusses
the submission of a new 586A request for the same sunscreen ingredient
for which a 586A or pending request had been previously submitted and
withdrawn.
    This guidance finalizes the draft guidance that was issued under
the same title on November 23, 2015 (see 80 FR 72970), and reflects
FDA's consideration of public comments on the draft guidance. The draft
guidance and related public comments are publicly available in Docket
No. FDA-2015-D-4012. In addition to minor editorial changes, we have
clarified the use of publicly available data and information submitted
to the docket as it pertains to the withdrawal process.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the withdrawal of 586A requests and pending
requests under the SIA. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

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

III. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are exempt
from the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA).
Section 586D(a)(1)(C) of the FD&C Act (21 U.S.C 360fff-4(a)(1)(C))
states that the PRA shall not apply to collections of information made
for purposes of guidance under section 586D(a).

    Dated: October 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24459 Filed 10-7-16; 8:45 am]
BILLING CODE 4164-01-P