548 Federal Register / Vol. 54, No. 4 / Friday, January 6, 1989 / Rules and Regulations developed in any such formal hearing permitted to examine the materials or any term, condition or restriction of will be part of the basis of the relevant to such proposals. Interested the license; and Administrator’s decisions on an persons will have at least 60 days after * * * * * application. publication of such notice to submit (b) Any action taken by the * * ■ * * * written comments to the Administrator, Administrator in accordance with 4. In § 970.302, paragraph (j) is (b) * * * paragraph (a)(1) will proceed pursuant amended by revising paragraph (j)(l)(i) (2) If the Administrator determines introductory text, and paragraph there exists one or more specific and to the procedures in 15 CFR 971.1003. (j)(l)(i)(A) to read as follows: material factual issues which require Any action taken in accordance with resolution by formal processes, at least paragraph (a)(2) will proceed pursuant § 970.302 Procedures and criteria for one formal hearing will be held in the to paragraphs (c) through (i) of this resolving conflicts. District of Columbia metropolitan area section, other than paragraph (h)(2). ***** in accordance with the provisions of * * * * * (j) Unresolved domestic conflict (1) Subpart I of 15 CFR Part 971. The record (e) If a timely request for P rocedure, (i) In the case of an original developed in any such formal hearing administrative review of the proposed domestic conflict or a new domestic will be part of the basis for the action is made by the licensee under conflict, the applicants will be allowed Administrator’s decisions on issuance or until April 15,1983, to resolve the transfer of, and of terms, conditions and paragraph (d)(1) of this section, the conflict or agree in writing to submit the restrictions for the license. Administrator will promptly begin a conflict to a specified binding conflict ***** formal hearing in accordance with resolution procedure. If, by April 15, Subpart I of 15 CFR Part 971. If the 1983, all applicants involved in an §970.508 [Amended] proposed action is the result of a original or new domestic conflict have 7. In § 970.508, paragraph (d) is correctable deficiency, the not resolved that conflict, or agreed in revised to read as follows: administrative review will proceed writing to submit the conflict to a * * * * * concurrently with any attempt to correct specified binding conflict resolution (d) If a timely request for the deficiency, unless the parties agree procedure, the conflict will be resolved administrative review of the proposed otherwise or the administrative law in a formal hearing held in accordance denial is made by the applicant under judge orders differently. with Subpart I of 15 CFR Part 971, paragraph (c)(1) of this section, the * * * * * except that: Administrator will promptly begin a (A) The General Counsel of NOAA formal hearing in accordance with (»)*** will not, as a matter of right, be a party Subpart I of 15 CFR Part 971. If the (2) The Administrator determines that to the hearing; however, the General proposed denial is the result of a immediate suspension of such a license, Counsel may be admitted to the hearing correctable deficiency, the or immediate suspension or modification by the administrative law judge as a administrative review will proceed of particular activities under a license, is party or as an interested person concurrently with any attempt to correct necessary to prevent a significant pursuant to 15 CFR 971.901 (f)(2) or (f)(3); the deficiency, unless the parties agree adverse effect on the environment or to and preserve the safety of life or property at * * • * * otherwise or the administrative law judge orders differently. sea, and the Administrator issues an * * * * * § 970.407 [Amended] emergency order in accordance with § 971.1003(d)(4). In § 970.407, paragraph (d) is revised §970.510 [Amended] ***** to read as follows: 8. In § 970.510, paragraph (d) is ***** 10. In Subpart I, § 970.900 is revised revised to read as follows: (d) If a timely request for * * * * ’* ' and § § 970.901 through 970.906 are removed, to read as follows: administrative review of the proposed (d) If, after the Administrator takes denial is made by the applicant under final action on an objection, the licensee § 970.900 Other applicable regulations. paragraph (c)(1) of this section, the demonstrates that a dispute remains on The regulations in Subparts H, I and ) Administrator will promptly begin a a material issue of fact, the of 15 CFR Part 971 are consolidated formal hearing in accordance with Administrator will provide for a formal Subpart I of 15 CFR Part 971. If the hearing which will proceed in regulations and are applicable both to proposed denial is the result of a accordance with Subpart I of 15 CFR licenses under this part and to permits correctable deficiency, the Part 971. under 15 CFR Part 971. The regulations administrative review will proceed 9. In § 970.511, paragraphs (a)(1), (b), in Subparts H, I and ] of Part 971 govern concurrently with any attempts to (e) and (i)(2) are revised to read as records to be maintained and correct the deficiency, unless the parties follows: information to be submitted by licensees agree otherwise or the administrative and permittees, public disclosure of law judge orders differently. § 970.511 Suspension or modification of documents received by NOAA, * * * * * activities; suspension or revocation of licenses. relinquishment and surrender of licenses 6. In § 970.501, paragraphs (a) and and permits, amendment of regulations, (a) The Administrator may: (b)(2) are revised to read as follows: competition of time, uniform hearing (1) In addition to, or in lieu of, the § 970.501 Proposal to issue or transfer imposition of any civil penalty under procedures, and enforcement under the and of terms, conditions and restrictions. Subpart J of 15 CFR Part 971, or in Act. (a) Notice and comment. The addition to the imposition of any fine Subparts J and K— [Removed and Administrator will publish in the under Subpart J, suspend or revoke any Reserved] Federal Register notice of each proposal license issued under this part, or to issue or transfer, and of terms and suspend or modify any particular 11. Subparts J and K (§§ 970.1000- conditions for, and restrictions on, an activities under such a license, if the 970.1107) are removed and reserved. exploration license. Subject to 15 CFR licensee substantially fails to comply [FR Doc. 89-162 Filed 1—5-89: 8:45 am] 971.802, interested persons will be with any provision of the Act, this part. BILLING CODE 3810-12-M Department of Health and Human Services Food and Drug Administration 21 CFR Parts 866 et al. Medical Devices; Intent To Initiate Proceedings To Establish the Effective Date of the Requirement for Premarket Approval for 31 Class III Preamendments Devices; Advance Notice of Proposed Rulemaking 550 Federal Register / Vol. 54, No. 4 / Friday, January 6, 1989 / Proposed Rules DEPARTMENT OF HEALTH AND device for which the general controls § 888.3 Effective dates o f requirement for HUMAN SERVICES authorized by or under various sections prem arket approval. of the act are sufficient to provide A device included in this part that is Food and Drug Administration reasonable assurance of the safety and classified into class III (premarket approval) shall not be commercially distributed after 21 CFR Parts 866,868,870,872,874, effectiveness of the device. A class II device is a device for which general the date shown m the regulation classifying 876,878,880,882,884,886,888, and the device unless the manufacturer has an 890 controls by themselves are insufficient approval under section 515 of the act (unless to provide reasonable assurance of the [Docket No. 88N-0244] an exemption has been granted under section safety and effectiveness of the device 520(g)(2) of the act). An approval under Medicai Devices; Intent To Initiate and for which there is sufficient section 515 of the act consists of FDA’s information to establish a performance issuance of an order approving an application Proceedings To Establish the Effective for premarket approval (PMA) for the device Dates of the Requirement for standard to provide such assurance. A class III device is a device that cannot or declaring completed a product Premarket Approval for 31 Class III development protocol (PDP) for the device. Preamendments Devices be classified into class I or class II and (a) Before FDA requires that a device that is purported or represented to be for commercially distributed before the a g e n c y : Food and Drug Administration. a use in supporting or sustaining human enactment date of the amendments, or a a c t io n : Advance notice of proposed life or for a use which is of substantial device that has been found substantially rulemaking. importance in preventing impairment of equivalent to such a device, has an approval human health or that presents a under section 515 of the act, FDA must s u m m a r y : The Food and Drug potential unreasonable risk of illness or promulgate a regulation under section 515(b) Administration (FDA) is announcing its of the act requiring such approval, except as injury. For a device in class III, intent to initiate proceedings to provided in paragraphs (b) and (c) of this premarket approval is required in establish the effective dates of thè section. Such a regulation under section accordance with section 515 of the act requirement for premarket approval for 515(b) of the act shall not be effective dining 31 class III preamendments devices. The (21 U.S.C.