Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability, 57623-57627 [2015-24218]

Download as PDF Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices Dated: September 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24228 Filed 9–23–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1939] Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled ‘‘Use of Investigational Tobacco Products.’’ The draft guidance, when finalized, will describe FDA’s current thinking regarding the definition of ‘‘investigational tobacco product’’ and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy. SUMMARY: 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft by November 23, 2015. Submit either electronic or written comments on the proposed collection of information by November 23, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance, including comments on the proposed collection of information, to https://www.regulations.gov. Submit written comments on the draft guidance, including comments on the proposed tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 collection of information, to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: Laura Rich or Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1– 877–287–1373, CTPRegulations@ fda.hhs.gov, laura.rich@fda.hhs.gov, or Deirdre.Jurand@fda.hhs.gov. With regard to the proposed collection of information: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993– 0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and investigators entitled ‘‘Use of Investigational Tobacco Products.’’ This draft guidance, when finalized, will describe FDA’s current thinking regarding the definition of ‘‘investigational tobacco product’’ and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy. It is intended to provide guidance not only to persons who currently intend to submit study information to FDA, but to all persons who conduct ‘‘nonclinical laboratory studies,’’ as that term is used in the draft guidance, and ‘‘clinical investigations,’’ as that term is used in the draft guidance, using investigational tobacco products. The draft guidance also discusses that for clinical investigations, a sponsor (as defined in the guidance) may submit information regarding a proposed use of an investigational tobacco product to FDA for review prior to enrolling subjects. As discussed in the guidance, FDA encourages this type of voluntary submission because it will allow FDA to work with a sponsor to help ensure that the factors FDA considers in making enforcement decisions are appropriately accounted for. FDA has created a form to assist sponsors in submitting information. While use of the form is voluntary, it will help ensure that PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 57623 complete information is provided for FDA’s consideration and will facilitate FDA’s processing and review. A copy of the form is attached as Appendix A to this guidance. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111– 31) (Tobacco Control Act) into law. The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. To introduce or deliver for introduction into interstate commerce a new tobacco product, there must be in effect a marketing authorization order issued by FDA for the tobacco product under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) unless, in brief: • A substantial equivalence order under section 910(a)(2)(A)(i) of the FD&C Act is in effect for the tobacco product; • FDA has granted a request for an exemption of the tobacco product from the requirement to obtain a substantial equivalence order and the manufacturer has made the required submission under section 905(j)(1)(A)(ii) of the FD&C Act and waited 90 days before introducing its product to the market; or • The manufacturer has submitted a substantial equivalence report in accordance with section 910(a)(2)(B) of the FD&C Act and there is no order finding that the tobacco product is not substantially equivalent. To introduce or deliver for introduction into interstate commerce a modified risk tobacco product, there must be in effect an order under section 911(g) of the FD&C Act (21 U.S.C. 387k(g)) and the applicant must satisfy any applicable premarket review requirements under section 910 of the FD&C Act. Further, a tobacco product must conform in all respects with applicable tobacco product standards established under section 907 of the FD&C Act (21 U.S.C. 387g). Persons intending to file submissions with FDA to demonstrate that a tobacco product meets the criteria for marketing set forth in section 910 or 911 of the FD&C Act, and other researchers seeking to study tobacco products, may need to conduct or sponsor studies involving tobacco products that do not have marketing authorization or that do not comply with an applicable tobacco product standard. E:\FR\FM\24SEN1.SGM 24SEN1 57624 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES Section 910(g) of the FD&C Act gives FDA the authority to issue regulations to exempt tobacco products intended for investigational use from the provisions of chapter IX of the FD&C Act, including premarket submission requirements. FDA intends to propose regulations establishing conditions for exempting investigational tobacco products from certain FD&C Act requirements. Until then, investigational tobacco products are not exempt from applicable FD&C Act requirements, including premarket submission requirements and tobacco product standards. This draft guidance discusses the factors FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products in both nonclinical laboratory studies and clinical investigations until regulations become effective or FDA provides written notice of its intent to change its enforcement policy. 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 ‘‘Use of Investigational Tobacco Products.’’ 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 statute and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance 1 The term ‘‘contract research organization’’ (CRO) as used in this draft guidance means a person VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Use of Investigational Tobacco Products (OMB Control Number 0910—NEW) FDA is announcing the availability of the draft guidance entitled ‘‘Use of Investigational Tobacco Products.’’ This guidance, when finalized, will describe FDA’s current thinking regarding the definition of ‘‘investigational tobacco product’’ and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations become effective or FDA provides written notice of its intent to change its enforcement policy. When finalized, it is intended to provide guidance, not only to persons who currently intend to submit study information to FDA, but to all persons who conduct nonclinical laboratory studies and clinical investigations using investigational tobacco products. Such persons may include sponsors, investigators, sponsor-investigators, contract research organizations (CROs),1 and committees or groups formally designated to oversee research involving human subjects (e.g., institutional review boards (IRBs)) involved in investigations using investigational tobacco products. We have identified the following recommendations in the draft guidance as collections of information. In the draft guidance, FDA provides examples of information that may help FDA to evaluate specific proposed uses of investigational tobacco products, and encourages persons who intend to study investigational tobacco products to meet with FDA to discuss certain topics in connection with nonclinical laboratory studies and clinical investigations. For clinical investigations, FDA encourages sponsors to submit information regarding a proposed use of an investigational tobacco product to FDA for review prior to enrolling subjects in the planned investigation. FDA has created a form to assist that assumes, as an independent contractor with the PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 sponsors in submitting information. While use of this form is voluntary, its use will likely reduce the burden hours and will help ensure that sponsors provide complete information for FDA’s consideration, processing, and review. Furthermore, to ensure that studies are conducted in a manner that protects human subjects, the draft guidance contains recommendations as to how sponsors should put procedures in place to keep FDA and the committee or group formally designated to oversee research involving human subjects informed about any changes relating to the conduct of, and issues that arise during, the study. In the draft guidance, FDA further recommends that sponsors, CROs, sponsor-investigators, and clinical investigators maintain documentation to permit evaluation of the conduct of a clinical investigation, including assessing the quality and integrity of the study data and protection of human subjects. In the draft guidance, FDA also recommends that sponsors consult with the Agency, clinical investigators, and any committee or group formally designated to oversee research involving human subjects when certain events occur during the conduct of a clinical investigation, including adverse experiences. In addition, FDA recommends that sponsors notify FDA if they choose to terminate a study (or withdraw or inactivate a protocol or want to withdraw all studies of a product) before completion and in the notification include certain information. Moreover, in the draft guidance, FDA recommends that under certain circumstances, sponsors also should inform any clinical investigators who participated in the discontinued investigation of the reason(s) for discontinuing the clinical investigation. FDA also makes recommendations related to nonclinical laboratory studies and clinical investigations of using investigational tobacco products conducted outside of the United States (U.S.), but intended for submission to FDA, and refers to section 801(e) of the FD&C Act with respect to exported tobacco products intended for investigational use. The guidance also recommends that sponsors should prepare and maintain certain records and reports, for studies conducted outside of the U.S. but intended for submission to FDA to permit FDA to evaluate the conduct of a clinical investigation, including assessing the quality and integrity of the study data and protection of human subjects. sponsor, one or more of the obligations of the sponsor (e.g., design of a protocol). E:\FR\FM\24SEN1.SGM 24SEN1 57625 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Initial Submission ......................... Protocol Submission .................... Protocol Amendments .................. Information Amendments ............. Administrative Amendments ........ Other Information ......................... Serious or Unexpected Adverse Experience Reports. First year, electronic set-up safety reporting portal. First year, Electronic Gateway setup and verification certificate (One time burden). Electronic Gateway Submission (recurring). Total Reporting Hours. tkelley on DSK3SPTVN1PROD with NOTICES 1 Respondent Burden 30 10 5 4 1 3 4 Total annual responses 1 1 1 1 1.5 1 3 Average burden per response 30 10 5 4 1.5 3 12 40 .............................. 20 .............................. 0.50 (30 minutes) ...... 15 .............................. 0.50 (30 minutes) ...... 0.50 (30 minutes) ...... 2 ................................ Total hours 1,200 200 2.5 60 0.75 1.5 24 ........................ ........................ ........................ ........................ ........................ ........................ ........................ 1 4 0.33 (20 minutes) ...... 30 1 30 42 1 ............................ 1,260 37,800 30 1 30 3 ................................ 90 2,700 .................................... 2,840 40,500 ........................ ........................ ........................ 1.3 Capital and operating and maintenance costs 4 ........................ may already have a valid WebTrader account established for other FDA electronic submissions. Table 1 describes the annual reporting burden as a result of respondents submitting information regarding the use of investigational tobacco products in certain clinical investigations. FDA estimates that 30 respondents will submit study information to FDA annually. FDA estimates that it will take each respondent approximately 40 hours to prepare the study information necessary for FDA to issue a response to the proposed use of an investigational tobacco product in these clinical investigations. FDA’s estimate includes the anticipated burden for completing the form for the initial submission, which will include the initial protocol, time for intra-company edits and approvals, as well as the burden for assembling additional information, as described in the draft guidance. The initial submission should include an initial study protocol, which should in turn include certain information and call for recordkeeping or other steps that may involve the submission of information to others. In addition, sponsors may wish to provide protocol amendments to reflect certain changes to a protocol. FDA estimates that 10 respondents will submit a new protocol. The estimated time for submitting a new protocol is 20 hours per response. Only 4 respondents are estimated to submit information amendments. Since this may take a little less than half the time of an initial submission, FDA estimates information amendments taking around 15 hours. VerDate Sep<11>2014 Number of responses per respondent Number of respondents Activity/FDA form 3934 16:45 Sep 23, 2015 Jkt 235001 FDA estimates that it could take respondents 30 minutes to prepare protocol amendments and that about 5 respondents submitting study information will submit protocol amendments. FDA estimates that respondents will infrequently need to report administrative amendments. The total number of respondents of this type of information is estimated to be 1. FDA estimates that this submission is estimated to take 30 minutes per respondent. FDA estimates that approximately 3 respondents will report other types of submissions. This submission is estimated to take 30 minutes per response. FDA estimates that 4 respondents will report serious or unexpected adverse experiences. This submission will take an average of 2 hours per respondent. FDA estimates that setting up an account in safety reporting portal for submission of serious or unexpected experiences will take 20 minutes per response. As referenced in the guidance, FDA allows for three ways of submission but strongly encourages the use of electronic format for submission. The submitter should first set up an account with WebTrader to go through the Electronic Submissions Gateway (ESG). FDA estimates from past experience with the ESG system, WebTrader, that the first year to set up the account and to receive the verification certificate takes approximately 40 hours. This burden PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 may be minimized if the respondent already has an established account in WebTrader for other electronic submissions to FDA, but FDA is assuming that all respondents for these products will be setting up a WebTrader account for the first time in the first year. In subsequent years, the burden hours are estimated at 1 hour to renew the yearly required Verification Certification. FDA further estimates that the gathering, scanning, and submission of information and related correspondence would take approximately 2 hours utilizing the eSubmitter system. Therefore, the first year will include 40 hours for the WebTrader system plus 2 hours for the eSubmitter submission process, resulting in 42 hours per response for the first year. For subsequent years, it is estimated that only 1 hour will be necessary for the WebTrader system plus the 2 hours for the eSubmitter submission process, resulting in 3 hours per response each year thereafter. Additionally, there are capital and operating or maintenance costs associated with this information collection. The costs are $30 per year to establish and maintain the ESG verification certificate. The total cost may be lower if the respondents already have a verification certificate for that year for other electronic submissions to FDA. However, for purposes of this estimate, FDA is assuming that all respondents for these products will be E:\FR\FM\24SEN1.SGM 24SEN1 57626 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices incurring this cost. The total costs are estimated to be $40,500. The total reporting burden for this collection of information is estimated to be 2,840 hours. These burden estimates were computed using FDA staff expertise and by reviewing comments received from recent FDA information collections for other tobacco-related initiatives. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity records maintained Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Records by Sponsors .......................................................... Records By Sponsor-Investigators ...................................... Records by Investigators and CROs ................................... 50 20 50 1 1 1 50 20 50 10 20 15 500 400 750 Total Recordkeeping Burden Hours ............................. ........................ ........................ ........................ ........................ 1,650 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2 describes the annual recordkeeping burden of maintaining records relating to the investigational use of tobacco products. FDA anticipates that 50 sponsors will maintain records relating to the use of investigational tobacco products in clinical investigations. FDA estimates that it will take each of them approximately 10 hours annually to maintain these records. FDA anticipates that there will generally be one investigator per investigation. FDA anticipates there will be a total of 120 sponsors, sponsor-investigators, investigators, and CROs who will maintain records relating to the use of investigational tobacco products in clinical investigations. FDA estimates that it will take each sponsor approximately 10 hours annually to maintain these records. FDA estimates that it will take each sponsorinvestigator approximately 20 hours annually to maintain these records. FDA estimates that it will take each of these investigators and CROs approximately 15 hours annually to maintain these records. The total reporting burden for recordkeeping is estimated to be 1,650 hours (500 hours for sponsors + 400 hours for sponsor-investigators + 750 for investigators and CROs.) TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents Activity Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Disclosures to Investigators ..................................... Disclosures to any Committee or Group ................. Disclosure to Study Subjects ................................... 30 30 30 1 1 2 30 30 60 1 ................................ 0.17 (10 minutes) ...... 0.50 (30 minutes) ...... 30 5 30 Total .................................................................. ........................ ........................ ........................ .................................... 65 tkelley on DSK3SPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3 describes the annual third party disclosure burden. FDA estimates that disclosing information to investigators will take 1 hour per disclosure. FDA estimates that disclosing information to any committee or group formally designated to oversee research involving human subjects will average 10 minutes per disclosure. The guidance also references examples of disclosing information to study subjects such as informed consent. On average, two disclosures per respondent will be provided to study subjects. FDA estimates this will take 30 minutes per disclosure. The total burden for the collection of information under this draft guidance is estimated to be 4,455 hours. This draft guidance also refers to previously approved collections of information. The draft guidance includes a recommendation that persons who intend to study tobacco products meet with FDA to discuss research VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 plans. Additional information about how to request meetings with FDA’s Center for Tobacco Products can be found in FDA’s guidance: ‘‘Meetings with Industry and Investigators on the Research and Development of Tobacco Products.’’ The collections of information in the guidance referenced have been approved under OMB control number 0910–0731. The collections of information in section 801(e) of the FD&C Act and 21 CFR 1.101(b) have been approved under OMB control number 0910–0482; the collections of information for the Safety Reporting Portal have been approved under OMB control number 0910–0645; the collections of information in section 905(j) of the FD&C Act have been approved under OMB control number 0910–0673. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 III. Request for Comments A. General Information About Submitting Comments Interested persons may submit either electronic comments regarding this document to https://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. B. Public Availability of Comments 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 https:// www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on https://www.regulations.gov. This is E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category ‘‘Individual Consumer’’ under the field titled ‘‘Category (Required),’’ on the ‘‘Your Information’’ page on www.regulations.gov. For this docket, however, FDA will not be following this general practice. Instead, FDA will post on https://www.regulations.gov comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20. C. Information Identifying the Person Submitting the Comment Please note that your name, contact information, and other information identifying you will be posted on https:// www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to https:// www.regulations.gov, FDA will post the body of your comment on https:// www.regulations.gov along with your state/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, consumer, academic, industry). For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on https://www.regulations.gov, but you can put your name and/or contact information on a separate cover sheet and not in the body of your comments. IV. Electronic Access Persons with access to the Internet may obtain an electronic version of this guidance document at https:// www.fda.gov/TobaccoProducts/ Labeling/RulesRegulationsGuidance/ ucm281147.htm or https:// www.regulations.gov. Dated: September 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24218 Filed 9–23–15; 8:45 am] BILLING CODE 4164–01–P tkelley on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 ACTION: Notice. Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/ mtgings/. DATES: The meeting will be held on Wednesday, October 21, 2015, from 8:30 a.m. until 5:00 p.m. and Thursday, October 22, 2015, from 8:30 a.m. until 4:30 p.m. ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP), or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240–453– 8141; fax: 240–453–6909; email address: SACHRP@hhs.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The meeting will open to the public at 8:30 a.m., on Wednesday, October 21, followed by opening remarks from Dr. Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair. The Committee will hear the Subpart A Subcommittee (SAS) and Subcommittee on Harmonization (SOH) reports on the recent Notice of Proposed Rulemaking (NPRM) titled Federal Policy for the Protection of Human Subjects (80 FR 53933, Sep. 8, 2015). Both days will be devoted to the discussion of the NPRM. SAS was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment. SOH was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 57627 would benefit from harmonization, consistency, clarity, simplification and/ or coordination. The meeting will adjourn at 4:30 p.m. October 22, 2015. Time for public comment sessions will be allotted both days. Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify one of the designated SACHRP points of contact at the address/phone number listed above at least one week prior to the meeting. Pre-registration is required for participation in the on-site public comment session; individuals may preregister the day of the meeting. Individuals who would like to submit written statements should email or fax their comments to SACHRP at SACHRP@hhs.gov at least five business days prior to the meeting. Dated: September 18, 2015. Jerry Menikoff, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections, Director, Office for Human Research Protections. [FR Doc. 2015–24264 Filed 9–23–15; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: Hospital Data Abstraction Form, Formerly Entitled Evaluation of Emergency Department Crisis Center Follow-Up—(OMB No. 0930–0337)— Revision The Substance Abuse and Mental Health Services Administration’s (SAMHSA), Center for Mental Health Services (CMHS) will conduct an evaluation to assess the impact of crisis center follow-up with patients admitted to emergency departments following a suicide attempt. E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57623-57627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24218]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1939]

Use of Investigational Tobacco Products; Draft Guidance for
Industry and Investigators; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and investigators
entitled ``Use of Investigational Tobacco Products.'' The draft
guidance, when finalized, will describe FDA's current thinking
regarding the definition of ``investigational tobacco product'' and
will discuss the kind of information FDA intends to consider in making
enforcement decisions regarding the use of investigational tobacco
products until regulations governing the use of investigational tobacco
products become effective or FDA provides written notice of its intent
to change its enforcement policy.

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 by
November 23, 2015. Submit either electronic or written comments on the
proposed collection of information by November 23, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Center for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your request or include a fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
Submit electronic comments on the draft guidance, including
comments on the proposed collection of information, to https://www.regulations.gov. Submit written comments on the draft guidance,
including comments on the proposed collection of information, to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.

FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Laura Rich or Deirdre Jurand,
Center for Tobacco Products, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373,
CTPRegulations@fda.hhs.gov, laura.rich@fda.hhs.gov, or
Deirdre.Jurand@fda.hhs.gov.
With regard to the proposed collection of information: FDA PRA
Staff, Office of Operations, Food and Drug Administration, 8455
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
and investigators entitled ``Use of Investigational Tobacco Products.''
This draft guidance, when finalized, will describe FDA's current
thinking regarding the definition of ``investigational tobacco
product'' and will discuss the kind of information FDA intends to
consider in making enforcement decisions regarding the use of
investigational tobacco products until regulations governing the use of
investigational tobacco products become effective or FDA provides
written notice of its intent to change its enforcement policy. It is
intended to provide guidance not only to persons who currently intend
to submit study information to FDA, but to all persons who conduct
``nonclinical laboratory studies,'' as that term is used in the draft
guidance, and ``clinical investigations,'' as that term is used in the
draft guidance, using investigational tobacco products.
The draft guidance also discusses that for clinical investigations,
a sponsor (as defined in the guidance) may submit information regarding
a proposed use of an investigational tobacco product to FDA for review
prior to enrolling subjects. As discussed in the guidance, FDA
encourages this type of voluntary submission because it will allow FDA
to work with a sponsor to help ensure that the factors FDA considers in
making enforcement decisions are appropriately accounted for. FDA has
created a form to assist sponsors in submitting information. While use
of the form is voluntary, it will help ensure that complete information
is provided for FDA's consideration and will facilitate FDA's
processing and review. A copy of the form is attached as Appendix A to
this guidance.
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control
Act) into law. The Tobacco Control Act amends the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) and grants FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect public health generally and to reduce tobacco use by minors.
To introduce or deliver for introduction into interstate commerce a
new tobacco product, there must be in effect a marketing authorization
order issued by FDA for the tobacco product under section
910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) unless, in
brief:
A substantial equivalence order under section
910(a)(2)(A)(i) of the FD&C Act is in effect for the tobacco product;
FDA has granted a request for an exemption of the tobacco
product from the requirement to obtain a substantial equivalence order
and the manufacturer has made the required submission under section
905(j)(1)(A)(ii) of the FD&C Act and waited 90 days before introducing
its product to the market; or
The manufacturer has submitted a substantial equivalence
report in accordance with section 910(a)(2)(B) of the FD&C Act and
there is no order finding that the tobacco product is not substantially
equivalent.
To introduce or deliver for introduction into interstate commerce a
modified risk tobacco product, there must be in effect an order under
section 911(g) of the FD&C Act (21 U.S.C. 387k(g)) and the applicant
must satisfy any applicable premarket review requirements under section
910 of the FD&C Act.
Further, a tobacco product must conform in all respects with
applicable tobacco product standards established under section 907 of
the FD&C Act (21 U.S.C. 387g).
Persons intending to file submissions with FDA to demonstrate that
a tobacco product meets the criteria for marketing set forth in section
910 or 911 of the FD&C Act, and other researchers seeking to study
tobacco products, may need to conduct or sponsor studies involving
tobacco products that do not have marketing authorization or that do
not comply with an applicable tobacco product standard.

[[Page 57624]]

Section 910(g) of the FD&C Act gives FDA the authority to issue
regulations to exempt tobacco products intended for investigational use
from the provisions of chapter IX of the FD&C Act, including premarket
submission requirements. FDA intends to propose regulations
establishing conditions for exempting investigational tobacco products
from certain FD&C Act requirements. Until then, investigational tobacco
products are not exempt from applicable FD&C Act requirements,
including premarket submission requirements and tobacco product
standards. This draft guidance discusses the factors FDA intends to
consider in making enforcement decisions regarding the use of
investigational tobacco products in both nonclinical laboratory studies
and clinical investigations until regulations become effective or FDA
provides written notice of its intent to change its enforcement policy.
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 ``Use of
Investigational Tobacco Products.'' 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 statute and regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Use of Investigational Tobacco Products (OMB Control Number 0910--NEW)

FDA is announcing the availability of the draft guidance entitled
``Use of Investigational Tobacco Products.'' This guidance, when
finalized, will describe FDA's current thinking regarding the
definition of ``investigational tobacco product'' and discuss the kind
of information FDA intends to consider in making enforcement decisions
regarding the use of investigational tobacco products until regulations
become effective or FDA provides written notice of its intent to change
its enforcement policy. When finalized, it is intended to provide
guidance, not only to persons who currently intend to submit study
information to FDA, but to all persons who conduct nonclinical
laboratory studies and clinical investigations using investigational
tobacco products. Such persons may include sponsors, investigators,
sponsor-investigators, contract research organizations (CROs),\1\ and
committees or groups formally designated to oversee research involving
human subjects (e.g., institutional review boards (IRBs)) involved in
investigations using investigational tobacco products.
---------------------------------------------------------------------------

\1\ The term ``contract research organization'' (CRO) as used in
this draft guidance means a person that assumes, as an independent
contractor with the sponsor, one or more of the obligations of the
sponsor (e.g., design of a protocol).
---------------------------------------------------------------------------

We have identified the following recommendations in the draft
guidance as collections of information.
In the draft guidance, FDA provides examples of information that
may help FDA to evaluate specific proposed uses of investigational
tobacco products, and encourages persons who intend to study
investigational tobacco products to meet with FDA to discuss certain
topics in connection with nonclinical laboratory studies and clinical
investigations.
For clinical investigations, FDA encourages sponsors to submit
information regarding a proposed use of an investigational tobacco
product to FDA for review prior to enrolling subjects in the planned
investigation. FDA has created a form to assist sponsors in submitting
information. While use of this form is voluntary, its use will likely
reduce the burden hours and will help ensure that sponsors provide
complete information for FDA's consideration, processing, and review.
Furthermore, to ensure that studies are conducted in a manner that
protects human subjects, the draft guidance contains recommendations as
to how sponsors should put procedures in place to keep FDA and the
committee or group formally designated to oversee research involving
human subjects informed about any changes relating to the conduct of,
and issues that arise during, the study. In the draft guidance, FDA
further recommends that sponsors, CROs, sponsor-investigators, and
clinical investigators maintain documentation to permit evaluation of
the conduct of a clinical investigation, including assessing the
quality and integrity of the study data and protection of human
subjects.
In the draft guidance, FDA also recommends that sponsors consult
with the Agency, clinical investigators, and any committee or group
formally designated to oversee research involving human subjects when
certain events occur during the conduct of a clinical investigation,
including adverse experiences. In addition, FDA recommends that
sponsors notify FDA if they choose to terminate a study (or withdraw or
inactivate a protocol or want to withdraw all studies of a product)
before completion and in the notification include certain information.
Moreover, in the draft guidance, FDA recommends that under certain
circumstances, sponsors also should inform any clinical investigators
who participated in the discontinued investigation of the reason(s) for
discontinuing the clinical investigation.
FDA also makes recommendations related to nonclinical laboratory
studies and clinical investigations of using investigational tobacco
products conducted outside of the United States (U.S.), but intended
for submission to FDA, and refers to section 801(e) of the FD&C Act
with respect to exported tobacco products intended for investigational
use. The guidance also recommends that sponsors should prepare and
maintain certain records and reports, for studies conducted outside of
the U.S. but intended for submission to FDA to permit FDA to evaluate
the conduct of a clinical investigation, including assessing the
quality and integrity of the study data and protection of human
subjects.

[[Page 57625]]

FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Capital and
Number of Number of Total annual operating and
Activity/FDA form 3934 respondents responses per responses Average burden per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Submission.................... 30 1 30 40................................. 1,200 ..............
Protocol Submission................... 10 1 10 20................................. 200 ..............
Protocol Amendments................... 5 1 5 0.50 (30 minutes).................. 2.5 ..............
Information Amendments................ 4 1 4 15................................. 60 ..............
Administrative Amendments............. 1 1.5 1.5 0.50 (30 minutes).................. 0.75 ..............
Other Information..................... 3 1 3 0.50 (30 minutes).................. 1.5 ..............
Serious or Unexpected Adverse 4 3 12 2.................................. 24 ..............
Experience Reports.
First year, electronic set-up safety 4 1 4 0.33 (20 minutes).................. 1.3 ..............
reporting portal.
First year, Electronic Gateway setup 30 1 30 42 \1\............................. 1,260 37,800
and verification certificate (One
time burden).
Electronic Gateway Submission 30 1 30 3.................................. 90 2,700
(recurring).
---------------------------------------------- ------------------------------
Total Reporting Burden Hours...... .............. ............. ............. ................................... 2,840 40,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Respondent may already have a valid WebTrader account established for other FDA electronic submissions.

Table 1 describes the annual reporting burden as a result of
respondents submitting information regarding the use of investigational
tobacco products in certain clinical investigations. FDA estimates that
30 respondents will submit study information to FDA annually. FDA
estimates that it will take each respondent approximately 40 hours to
prepare the study information necessary for FDA to issue a response to
the proposed use of an investigational tobacco product in these
clinical investigations. FDA's estimate includes the anticipated burden
for completing the form for the initial submission, which will include
the initial protocol, time for intra-company edits and approvals, as
well as the burden for assembling additional information, as described
in the draft guidance.
The initial submission should include an initial study protocol,
which should in turn include certain information and call for
recordkeeping or other steps that may involve the submission of
information to others. In addition, sponsors may wish to provide
protocol amendments to reflect certain changes to a protocol. FDA
estimates that 10 respondents will submit a new protocol. The estimated
time for submitting a new protocol is 20 hours per response. Only 4
respondents are estimated to submit information amendments. Since this
may take a little less than half the time of an initial submission, FDA
estimates information amendments taking around 15 hours.
FDA estimates that it could take respondents 30 minutes to prepare
protocol amendments and that about 5 respondents submitting study
information will submit protocol amendments.
FDA estimates that respondents will infrequently need to report
administrative amendments. The total number of respondents of this type
of information is estimated to be 1. FDA estimates that this submission
is estimated to take 30 minutes per respondent.
FDA estimates that approximately 3 respondents will report other
types of submissions. This submission is estimated to take 30 minutes
per response.
FDA estimates that 4 respondents will report serious or unexpected
adverse experiences. This submission will take an average of 2 hours
per respondent. FDA estimates that setting up an account in safety
reporting portal for submission of serious or unexpected experiences
will take 20 minutes per response.
As referenced in the guidance, FDA allows for three ways of
submission but strongly encourages the use of electronic format for
submission. The submitter should first set up an account with WebTrader
to go through the Electronic Submissions Gateway (ESG). FDA estimates
from past experience with the ESG system, WebTrader, that the first
year to set up the account and to receive the verification certificate
takes approximately 40 hours. This burden may be minimized if the
respondent already has an established account in WebTrader for other
electronic submissions to FDA, but FDA is assuming that all respondents
for these products will be setting up a WebTrader account for the first
time in the first year. In subsequent years, the burden hours are
estimated at 1 hour to renew the yearly required Verification
Certification.
FDA further estimates that the gathering, scanning, and submission
of information and related correspondence would take approximately 2
hours utilizing the eSubmitter system.
Therefore, the first year will include 40 hours for the WebTrader
system plus 2 hours for the eSubmitter submission process, resulting in
42 hours per response for the first year. For subsequent years, it is
estimated that only 1 hour will be necessary for the WebTrader system
plus the 2 hours for the eSubmitter submission process, resulting in 3
hours per response each year thereafter.
Additionally, there are capital and operating or maintenance costs
associated with this information collection. The costs are $30 per year
to establish and maintain the ESG verification certificate. The total
cost may be lower if the respondents already have a verification
certificate for that year for other electronic submissions to FDA.
However, for purposes of this estimate, FDA is assuming that all
respondents for these products will be

[[Page 57626]]

incurring this cost. The total costs are estimated to be $40,500.
The total reporting burden for this collection of information is
estimated to be 2,840 hours. These burden estimates were computed using
FDA staff expertise and by reviewing comments received from recent FDA
information collections for other tobacco-related initiatives.

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity records maintained Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Records by Sponsors............. 50 1 50 10 500
Records By Sponsor-Investigators 20 1 20 20 400
Records by Investigators and 50 1 50 15 750
CROs...........................
-------------------------------------------------------------------------------
Total Recordkeeping Burden .............. .............. .............. .............. 1,650
Hours......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2 describes the annual recordkeeping burden of maintaining
records relating to the investigational use of tobacco products. FDA
anticipates that 50 sponsors will maintain records relating to the use
of investigational tobacco products in clinical investigations. FDA
estimates that it will take each of them approximately 10 hours
annually to maintain these records. FDA anticipates that there will
generally be one investigator per investigation. FDA anticipates there
will be a total of 120 sponsors, sponsor-investigators, investigators,
and CROs who will maintain records relating to the use of
investigational tobacco products in clinical investigations. FDA
estimates that it will take each sponsor approximately 10 hours
annually to maintain these records. FDA estimates that it will take
each sponsor-investigator approximately 20 hours annually to maintain
these records. FDA estimates that it will take each of these
investigators and CROs approximately 15 hours annually to maintain
these records. The total reporting burden for recordkeeping is
estimated to be 1,650 hours (500 hours for sponsors + 400 hours for
sponsor-investigators + 750 for investigators and CROs.)

Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosures to Investigators................ 30 1 30 1......................................... 30
Disclosures to any Committee or Group....... 30 1 30 0.17 (10 minutes)......................... 5
Disclosure to Study Subjects................ 30 2 60 0.50 (30 minutes)......................... 30
------------------------------------------------ ---------------
Total................................... .............. .............. .............. .......................................... 65
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3 describes the annual third party disclosure burden.
FDA estimates that disclosing information to investigators will
take 1 hour per disclosure. FDA estimates that disclosing information
to any committee or group formally designated to oversee research
involving human subjects will average 10 minutes per disclosure.
The guidance also references examples of disclosing information to
study subjects such as informed consent. On average, two disclosures
per respondent will be provided to study subjects. FDA estimates this
will take 30 minutes per disclosure.
The total burden for the collection of information under this draft
guidance is estimated to be 4,455 hours.
This draft guidance also refers to previously approved collections
of information. The draft guidance includes a recommendation that
persons who intend to study tobacco products meet with FDA to discuss
research plans. Additional information about how to request meetings
with FDA's Center for Tobacco Products can be found in FDA's guidance:
``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products.'' The collections of information in
the guidance referenced have been approved under OMB control number
0910-0731. The collections of information in section 801(e) of the FD&C
Act and 21 CFR 1.101(b) have been approved under OMB control number
0910-0482; the collections of information for the Safety Reporting
Portal have been approved under OMB control number 0910-0645; the
collections of information in section 905(j) of the FD&C Act have been
approved under OMB control number 0910-0673.

III. Request for Comments

A. General Information About Submitting Comments

Interested persons may submit either electronic comments regarding
this document to https://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.

B. Public Availability of Comments

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 https://www.regulations.gov. As a matter of Agency
practice, FDA generally does not post comments submitted by individuals
in their individual capacity on https://www.regulations.gov. This is

[[Page 57627]]

determined by information indicating that the submission is written by
an individual, for example, the comment is identified with the category
``Individual Consumer'' under the field titled ``Category (Required),''
on the ``Your Information'' page on www.regulations.gov. For this
docket, however, FDA will not be following this general practice.
Instead, FDA will post on https://www.regulations.gov comments to this
docket that have been submitted by individuals in their individual
capacity. If you wish to submit any information under a claim of
confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

Please note that your name, contact information, and other
information identifying you will be posted on https://www.regulations.gov if you include that information in the body of your
comments. For electronic comments submitted to https://www.regulations.gov, FDA will post the body of your comment on https://www.regulations.gov along with your state/province and country (if
provided), the name of your representative (if any), and the category
identifying you (e.g., individual, consumer, academic, industry). For
written submissions submitted to the Division of Dockets Management,
FDA will post the body of your comments on https://www.regulations.gov,
but you can put your name and/or contact information on a separate
cover sheet and not in the body of your comments.

IV. Electronic Access

Persons with access to the Internet may obtain an electronic
version of this guidance document at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm281147.htm or
https://www.regulations.gov.

Dated: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24218 Filed 9-23-15; 8:45 am]
BILLING CODE 4164-01-P

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