Amendments to the Definition of Broker or Dealer in Securities

was not conducted in compliance with
part 58 of this chapter, a brief statement
of the reason for the noncompliance. (x) The submission does not contain a statement for each clinical investigation involving human subjects that it was conducted in compliance with the institutional review board regulations in part 56 of this chapter, or was not subject to those regulations, and that it was conducted in compliance with the informed consent regulations in part 50 of this chapter. (xi) The submission does not include financial certification or disclosure statements, or both, as required by part 54 of this chapter, accompanying any clinical data submitted. (k) Withdrawal of consideration. (1) FDA may withdraw consideration of a TEA submission or a safety and effectiveness data submission if:
(i) The sponsor requests that its submission be withdrawn from consideration, or (ii) FDA deems the submission to be withdrawn from consideration due to the sponsor’s failure to act on the submission or failure to respond to communications from FDA. (2) Before FDA deems a submission withdrawn under paragraph (k)(1)(ii) of this section, FDA will notify the sponsor of the submission. If, within 30 days from the date of the notice from FDA, the sponsor requests that FDA not withdraw consideration of the submission, FDA will not deem the submission to be withdrawn. (3) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, FDA will post a notice of withdrawal to the docket. Information that has been posted to the public docket for the TEA at the time of the withdrawal (such as a notice of eligibility or a safety and effectiveness data submission that has been accepted for filing and posted to the docket) will remain on the public docket. (4) If FDA withdraws consideration of a submission under paragraph (k)(1) of this section, the timelines under § 330.15(c) will no longer apply as of the date of withdrawal, and the submission will not be included in the metrics under § 330.15(b).

• 3. Add § 330.15 to subpart B to read
  as follows:
  § 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions. (a) Applicability. This section applies to the review of a condition in a time and extent application (TEA) submitted under § 330.14 for consideration in the over-the-counter (OTC) drug monograph system. This section does not apply to:
  (1) A sunscreen active ingredient or combination of sunscreen active ingredients, and other conditions for such ingredients, or (2) A non-sunscreen active ingredient or combination of non-sunscreen active ingredients and other conditions for such ingredients submitted in a TEA under § 330.14 prior to November 27, 2014, subject to section 586F(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act. (b) Metrics. FDA will maintain and update annually, a publicly available posting of metrics for the review of TEAs and safety and effectiveness data submissions that are subject to the timelines in this section. The posting will contain the following information for tracking the extent to which the timelines set forth in paragraph (c) of this section were met during the previous calendar year. (1) Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA; (2) Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission; (3) If applicable, number and percent of feedback letters issued within 730 days from the date of filing; (4) Number and percent of notices for proposed rulemaking issued within 1,095 days from the date of filing; (5) Number and percent of final rules issued within 912 days of closing of the docket of the proposed rulemaking; and (6) Total number of TEAs submitted under § 330.14. (c) Timelines for FDA review and action. FDA will review and take an action within the following timelines:
  (1) Within 180 days of submission of a TEA under § 330.14(c), FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e). (2) Within 90 days of submission by the sponsor of a safety and effectiveness data submission, FDA will issue a filing determination in accordance with § 330.14(j). The date of filing begins the FDA timelines in paragraphs (c)(3) and (4) of this section. (3) Within 730 days from the date of filing, if the condition is initially determined not to be GRASE for OTC use in the United States, FDA will inform the sponsor and other interested parties who have submitted data of its determination by feedback letter in accordance with § 330.14(g)(4). (4) Within 1,095 days from the date of filing of a safety and effectiveness data submission, FDA will issue a notice of proposed rulemaking to either:
  (i) Include the condition in an appropriate OTC monograph(s), either by amending an existing monograph(s) or establishing a new monograph(s), if necessary; or (ii) Include the condition in § 310.502 of this chapter. (5) Within 912 days of the closing of the docket of the proposed rulemaking under paragraph (c)(4) of this section, FDA will issue a final rule. Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–07612 Filed 4–1–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Financial Crimes Enforcement Network 31 CFR Parts 1010 and 1023 RIN 1506–AB29 Amendments to the Definition of Broker or Dealer in Securities AGENCY: Financial Crimes Enforcement Network (‘‘FinCEN’’), Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: FinCEN, a bureau of the Department of the Treasury, is proposing amendments to the definitions of ‘‘broker or dealer in securities’’ and ‘‘broker-dealer’’ under the regulations implementing the Bank Secrecy Act. This rulemaking would amend those definitions explicitly to include funding portals that are involved in the offering or selling of crowdfunding securities pursuant to
  section 4(a)(6) of the Securities Act of

1933. The consequence of those
      amendments would be that funding portals would be required to implement policies and procedures reasonably designed to achieve compliance with the Bank Secrecy Act requirements currently applicable to brokers or dealers in securities. The proposal to specifically require funding portals to comply with the Bank Secrecy Act regulations is intended to help prevent money laundering, terrorist financing, and other financial crimes. DATES: Written comments on this Notice of Proposed Rulemaking (‘‘NPRM’’) must be submitted on or before June 3, 2016. ADDRESSES: Comments may be submitted, identified by Regulatory Identification Number (RIN) 1506– AB29, by any of the following methods:

• Federal E-rulemaking Portal: http://
  www.regulations.gov. Follow the instructions for submitting comments.