80 FR 57623 - Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 185 (September 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 185 (September 24, 2015)
| Page Range | 57623-57627 | |
| FR Document | 2015-24218 |
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)] [Notices] [Pages 57623-57627] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24218] ----------------------------------------------------------------------- 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AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1939] Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled ``Use of Investigational Tobacco Products.'' The draft guidance, when finalized, will describe FDA's current thinking regarding the definition of ``investigational tobacco product'' and will discuss the kind of information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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft by November 23, 2015.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 ADDRESSES: Submit written requests for single copies of the draft guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993.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one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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 http://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, [email protected], [email protected], or [email protected]. 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, [email protected]. 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 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. 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 http://www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on http://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 http://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 http://www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://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 http://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 http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm281147.htm or http://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
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57623
Dated: September 17, 2015. collection of information, to the complete information is provided for
Leslie Kux, Division of Dockets Management (HFA– FDA’s consideration and will facilitate
Associate Commissioner for Policy. 305), Food and Drug Administration, FDA’s processing and review. A copy of
[FR Doc. 2015–24228 Filed 9–23–15; 8:45 am] 5630 Fishers Lane, Rm. 1061, Rockville, the form is attached as Appendix A to
BILLING CODE 4164–01–P
MD 20852. All comments should be this guidance.
identified with the docket number On June 22, 2009, the President
found in brackets in the heading of this signed the Family Smoking Prevention
DEPARTMENT OF HEALTH AND document. and Tobacco Control Act (Pub. L. 111–
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: 31) (Tobacco Control Act) into law. The
With regard to the draft guidance: Tobacco Control Act amends the
Food and Drug Administration Laura Rich or Deirdre Jurand, Center for Federal Food, Drug, and Cosmetic Act
[Docket No. FDA–2014–D–1939] Tobacco Products, Food and Drug (the FD&C Act) and grants FDA
Administration, 10903 New Hampshire authority to regulate the manufacture,
Use of Investigational Tobacco Ave., Silver Spring, MD 20993–0002, 1– marketing, and distribution of tobacco
Products; Draft Guidance for Industry 877–287–1373, CTPRegulations@ products to protect public health
and Investigators; Availability fda.hhs.gov, laura.rich@fda.hhs.gov, or generally and to reduce tobacco use by
Deirdre.Jurand@fda.hhs.gov. minors.
AGENCY: Food and Drug Administration, With regard to the proposed collection To introduce or deliver for
HHS. of information: FDA PRA Staff, Office of introduction into interstate commerce a
ACTION: Notice. Operations, Food and Drug new tobacco product, there must be in
Administration, 8455 Colesville Rd., effect a marketing authorization order
SUMMARY: The Food and Drug issued by FDA for the tobacco product
COLE–14526, Silver Spring, MD 20993–
Administration (FDA) is announcing the under section 910(c)(1)(A)(i) of the
0002, PRAStaff@fda.hhs.gov.
availability of a draft guidance for FD&C Act (21 U.S.C. 387j(c)(1)(A)(i))
industry and investigators entitled ‘‘Use SUPPLEMENTARY INFORMATION:
unless, in brief:
of Investigational Tobacco Products.’’ I. Background • A substantial equivalence order
The draft guidance, when finalized, will under section 910(a)(2)(A)(i) of the
describe FDA’s current thinking FDA is announcing the availability of
a draft guidance for industry and FD&C Act is in effect for the tobacco
regarding the definition of product;
‘‘investigational tobacco product’’ and investigators entitled ‘‘Use of
Investigational Tobacco Products.’’ This • FDA has granted a request for an
will discuss the kind of information
draft guidance, when finalized, will exemption of the tobacco product from
FDA intends to consider in making
describe FDA’s current thinking the requirement to obtain a substantial
enforcement decisions regarding the use
regarding the definition of equivalence order and the manufacturer
of investigational tobacco products until
‘‘investigational tobacco product’’ and has made the required submission
regulations governing the use of
will discuss the kind of information under section 905(j)(1)(A)(ii) of the
investigational tobacco products become
FDA intends to consider in making FD&C Act and waited 90 days before
effective or FDA provides written notice
enforcement decisions regarding the use introducing its product to the market; or
of its intent to change its enforcement
of investigational tobacco products until • The manufacturer has submitted a
policy.
regulations governing the use of substantial equivalence report in
DATES: Although you can comment on investigational tobacco products become accordance with section 910(a)(2)(B) of
any guidance at any time (see 21 CFR effective or FDA provides written notice the FD&C Act and there is no order
10.115(g)(5)), to ensure that the Agency of its intent to change its enforcement finding that the tobacco product is not
considers your comment on this draft policy. It is intended to provide substantially equivalent.
guidance before it begins work on the guidance not only to persons who To introduce or deliver for
final version of the guidance, submit currently intend to submit study introduction into interstate commerce a
either electronic or written comments information to FDA, but to all persons modified risk tobacco product, there
on the draft by November 23, 2015. who conduct ‘‘nonclinical laboratory must be in effect an order under section
Submit either electronic or written studies,’’ as that term is used in the draft 911(g) of the FD&C Act (21 U.S.C.
comments on the proposed collection of guidance, and ‘‘clinical investigations,’’ 387k(g)) and the applicant must satisfy
information by November 23, 2015. as that term is used in the draft any applicable premarket review
ADDRESSES: Submit written requests for guidance, using investigational tobacco requirements under section 910 of the
single copies of the draft guidance to the products. FD&C Act.
Center for Tobacco Products, Food and The draft guidance also discusses that Further, a tobacco product must
Drug Administration, 10903 New for clinical investigations, a sponsor (as conform in all respects with applicable
Hampshire Ave., Silver Spring, MD defined in the guidance) may submit tobacco product standards established
20993. Send one self-addressed information regarding a proposed use of under section 907 of the FD&C Act (21
adhesive label to assist that office in an investigational tobacco product to U.S.C. 387g).
processing your request or include a fax FDA for review prior to enrolling Persons intending to file submissions
number to which the draft guidance subjects. As discussed in the guidance, with FDA to demonstrate that a tobacco
may be sent. See the SUPPLEMENTARY FDA encourages this type of voluntary product meets the criteria for marketing
INFORMATION section for electronic submission because it will allow FDA to set forth in section 910 or 911 of the
tkelley on DSK3SPTVN1PROD with NOTICES
access to the draft guidance document. work with a sponsor to help ensure that FD&C Act, and other researchers seeking
Submit electronic comments on the the factors FDA considers in making to study tobacco products, may need to
draft guidance, including comments on enforcement decisions are appropriately conduct or sponsor studies involving
the proposed collection of information, accounted for. FDA has created a form tobacco products that do not have
to http://www.regulations.gov. Submit to assist sponsors in submitting marketing authorization or that do not
written comments on the draft guidance, information. While use of the form is comply with an applicable tobacco
including comments on the proposed voluntary, it will help ensure that product standard.
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57808/page/1.svg)
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57627
determined by information indicating ACTION: Notice. would benefit from harmonization,
that the submission is written by an consistency, clarity, simplification and/
individual, for example, the comment is SUMMARY: Pursuant to Section 10(a) of or coordination.
identified with the category ‘‘Individual the Federal Advisory Committee Act, 5
The meeting will adjourn at 4:30 p.m.
Consumer’’ under the field titled U.S.C. App 2, notice is hereby given that
October 22, 2015. Time for public
‘‘Category (Required),’’ on the ‘‘Your the Secretary’s Advisory Committee on
comment sessions will be allotted both
Information’’ page on Human Research Protections (SACHRP)
days.
www.regulations.gov. For this docket, will hold a meeting that will be open to
the public. Information about SACHRP Public attendance at the meeting is
however, FDA will not be following this
and the full meeting agenda will be limited to space available. Individuals
general practice. Instead, FDA will post
posted on the SACHRP Web site at: who plan to attend and need special
on http://www.regulations.gov
http://www.dhhs.gov/ohrp/sachrp/ assistance, such as sign language
comments to this docket that have been
submitted by individuals in their mtgings/index.html. interpretation or other reasonable
individual capacity. If you wish to DATES: The meeting will be held on
accommodations, should notify one of
submit any information under a claim of Wednesday, October 21, 2015, from 8:30 the designated SACHRP points of
confidentiality, please refer to 21 CFR a.m. until 5:00 p.m. and Thursday, contact at the address/phone number
10.20. October 22, 2015, from 8:30 a.m. until listed above at least one week prior to
4:30 p.m. the meeting. Pre-registration is required
C. Information Identifying the Person for participation in the on-site public
Submitting the Comment ADDRESSES: Fishers Lane Conference
comment session; individuals may pre-
Center, Terrace Level, 5635 Fishers register the day of the meeting.
Please note that your name, contact Lane, Rockville, Maryland 20852.
information, and other information Individuals who would like to submit
FOR FURTHER INFORMATION CONTACT: Jerry written statements should email or fax
identifying you will be posted on http://
Menikoff, M.D., J.D., Director, Office for their comments to SACHRP at
www.regulations.gov if you include that
Human Research Protections (OHRP), or SACHRP@hhs.gov at least five business
information in the body of your
Julia Gorey, J.D., Executive Director, days prior to the meeting.
comments. For electronic comments
SACHRP; U.S. Department of Health
submitted to http:// Dated: September 18, 2015.
and Human Services, 1101 Wootton
www.regulations.gov, FDA will post the Jerry Menikoff,
Parkway, Suite 200, Rockville,
body of your comment on http:// Executive Secretary, Secretary’s Advisory
Maryland 20852; telephone: 240–453–
www.regulations.gov along with your Committee on Human Research Protections,
8141; fax: 240–453–6909; email address:
state/province and country (if Director, Office for Human Research
SACHRP@hhs.gov.
provided), the name of your Protections.
representative (if any), and the category SUPPLEMENTARY INFORMATION: Under the
[FR Doc. 2015–24264 Filed 9–23–15; 8:45 am]
identifying you (e.g., individual, authority of 42 U.S.C. 217a, Section 222
BILLING CODE 4150–36–P
consumer, academic, industry). For of the Public Health Service Act, as
written submissions submitted to the amended, SACHRP was established to
Division of Dockets Management, FDA provide expert advice and DEPARTMENT OF HEALTH AND
will post the body of your comments on recommendations to the Secretary of HUMAN SERVICES
http://www.regulations.gov, but you can Health and Human Services, through
put your name and/or contact the Assistant Secretary for Health, on Substance Abuse and Mental Health
information on a separate cover sheet issues and topics pertaining to or Services Administration
and not in the body of your comments. associated with the protection of human
research subjects. Agency Information Collection
IV. Electronic Access The meeting will open to the public Activities: Submission for OMB
Persons with access to the Internet at 8:30 a.m., on Wednesday, October 21, Review; Comment Request
may obtain an electronic version of this followed by opening remarks from Dr.
guidance document at http:// Jerry Menikoff, Executive Secretary of Periodically, the Substance Abuse and
www.fda.gov/TobaccoProducts/ SACHRP and OHRP Director, and Dr. Mental Health Services Administration
Labeling/RulesRegulationsGuidance/ Jeffrey Botkin, SACHRP Chair. The (SAMHSA) will publish a summary of
ucm281147.htm or http:// Committee will hear the Subpart A information collection requests under
www.regulations.gov. Subcommittee (SAS) and Subcommittee OMB review, in compliance with the
on Harmonization (SOH) reports on the Paperwork Reduction Act (44 U.S.C.
Dated: September 16, 2015. Chapter 35). To request a copy of these
recent Notice of Proposed Rulemaking
Leslie Kux, documents, call the SAMHSA Reports
(NPRM) titled Federal Policy for the
Associate Commissioner for Policy. Protection of Human Subjects (80 FR Clearance Officer on (240) 276–1243.
[FR Doc. 2015–24218 Filed 9–23–15; 8:45 am] 53933, Sep. 8, 2015). Both days will be Project: Hospital Data Abstraction
BILLING CODE 4164–01–P devoted to the discussion of the NPRM. Form, Formerly Entitled Evaluation of
SAS was established by SACHRP in Emergency Department Crisis Center
October 2006 and is charged with Follow-Up—(OMB No. 0930–0337)—
DEPARTMENT OF HEALTH AND developing recommendations for
HUMAN SERVICES Revision
consideration by SACHRP regarding the
application of subpart A of 45 CFR part The Substance Abuse and Mental
Meeting of the Secretary’s Advisory
tkelley on DSK3SPTVN1PROD with NOTICES
46 in the current research environment. Health Services Administration’s
Committee on Human Research
SOH was established by SACHRP at (SAMHSA), Center for Mental Health
Protections
its July 2009 meeting and charged with Services (CMHS) will conduct an
AGENCY: Office of the Assistant identifying and prioritizing areas in evaluation to assess the impact of crisis
Secretary for Health, Office of the which regulations and/or guidelines for center follow-up with patients admitted
Secretary, Department of Health and human subjects research adopted by to emergency departments following a
Human Services. various agencies or offices within HHS suicide attempt.
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57808/page/5.svg)
Document Created: 2018-02-26 10:17:47
Document Modified: 2018-02-26 10:17:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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, [email protected], [email protected], or D[email protected] | |
| FR Citation | 80 FR 57623 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR