80_FR_14892 80 FR 14838 - Advisory Committee; Antiviral Drugs Advisory Committee; Termination

80 FR 14838 - Advisory Committee; Antiviral Drugs Advisory Committee; Termination

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 54 (March 20, 2015)

Page Range14838-14839
FR Document2015-06425

The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.

Federal Register, Volume 80 Issue 54 (Friday, March 20, 2015) 
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Rules and Regulations]
[Pages 14838-14839]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2012-N-0218]


Advisory Committee; Antiviral Drugs Advisory Committee; 
Termination

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of the Antiviral Drugs Advisory Committee. This document 
removes the Antiviral Drugs Advisory Committee from the Agency's list 
of standing advisory committees.

DATES: This rule is effective March 20, 2015.

[[Page 14839]]


FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-
796-8220, FAX: 301-847-8640, or [email protected].

SUPPLEMENTARY INFORMATION: The Antiviral Drugs Advisory Committee was 
established on October 7, 1980 (see 45 FR 79025, November 28, 1980). 
The Committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of acquired immune deficiency 
syndrome, human immunodeficiency virus related illnesses, and other 
viral, fungal and mycobacterial infections. The Committee is no longer 
needed and was terminated on February 15, 2015.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the Agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule merely removes 
the name of the Antiviral Drugs Advisory Committee from the list of 
standing advisory committees in Sec.  14.100 (21 CFR 14.100).
    Therefore, the Agency is amending Sec.  14.100(c) as set forth in 
the regulatory text of this document.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. 
L. 113-54.


Sec.  14.100  [Amended]

0
2. Section 14.100 is amended by removing paragraph (c)(3) and 
redesignating paragraphs (c)(4) through (18) as paragraphs (c)(3) 
through (17).

    Dated: March 16, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-06425 Filed 3-19-15; 8:45 am]
 BILLING CODE 4164-01-P

14838 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations eligible for benefits (see paragraph (5) Your daily activities both before Subpart O—[Amended] (b)(2)(iv) of this section). and after the date you say that you became disabled; ■ 16. The authority citation for subpart (iii) The provisions of paragraph O of part 416 continues to read as (b)(2)(i) apply to communications (6) Your efforts to work; and follows: between you and your non-attorney (7) Any other factors showing how Authority: Secs. 702(a)(5), 1127, and representative only if the your impairment(s) affects your ability 1631(d) of the Social Security Act (42 U.S.C. communications would be subject to the to work. In §§ 416.960 through 902(a)(5), 1320a–6, and 1383(d)). attorney-client privilege, if your non- 416.969a, we discuss in more detail the attorney representative were an ■ 17. In § 416.1540, revise paragraphs evidence we need when we consider attorney. The provisions of paragraph (b)(1) and (b)(2)(i) through (vi) and add vocational factors. (b)(2)(ii) apply to the analysis of your paragraph (b)(2)(vii) to read as follows: claim by your non-attorney * * * * * § 416.1540 Rules of conduct and representative only if the analysis of standards of responsibility for Subpart N—[Amended] your claim would be subject to the representatives. attorney work product doctrine, if your 13. The authority citation for subpart ■ * * * * * non-attorney representative were an N of part 416 continues to read as (b) * * * attorney. follows: (1) Act with reasonable promptness to (iv) The attorney-client privilege help obtain the information or evidence generally protects confidential Authority: Secs. 702(a)(5), 1631, and 1633 of the Social Security Act (42 U.S.C. that the claimant must submit under our communications between an attorney regulations, and forward the 902(a)(5), 1383, and 1383b); sec. 202, Pub. L. and his or her client that are related to 108–203, 118 Stat. 509 (42 U.S.C. 902 note). information or evidence to us for providing or obtaining legal advice. The consideration as soon as practicable. attorney work product doctrine ■ 14. Amend § 416.1400 by revising (2) * * * generally protects an attorney’s analysis, paragraph (b) to read as follows: (i) The claimant’s medical source(s); theories, mental impressions, and notes. (ii) The claimant’s age; In the context of your disability claim, § 416.1400 Introduction. (iii) The claimant’s education and neither the attorney-client privilege nor * * * * * training; the attorney work product doctrine (iv) The claimant’s work experience; (b) Nature of the administrative allows you to withhold factual (v) The claimant’s daily activities both review process. In making a information, medical source opinions, before and after the date the claimant determination or decision in your case, or other medical evidence that we may alleges that he or she became disabled; we conduct the administrative review consider in determining whether or not (vi) The claimant’s efforts to work; process in an informal, non-adversarial you are eligible for benefits. For and manner. Subject to the limitations on example, if you tell your representative (vii) Any other factors showing how Appeals Council consideration of about the medical sources you have the claimant’s impairment(s) affects his additional evidence (see §§ 416.1470(b) seen, your representative cannot refuse or her ability to work. In §§ 416.960 and 416.1476(b)), we will consider at to disclose the identity of those medical through 416.969a, we discuss in more each step of the review process any sources to us based on the attorney- detail the evidence we need when we information you present as well as all client privilege. As another example, if consider vocational factors; the information in our records. You may your representative asks a medical * * * * * present the information yourself or have source to complete an opinion form [FR Doc. 2015–05921 Filed 3–19–15; 8:45 am] someone represent you, including an related to your impairment(s), BILLING CODE 4191–02–P attorney. If you are dissatisfied with our symptoms, or limitations, your decision in the review process, but do representative cannot withhold the not take the next step within the stated completed opinion form from us based DEPARTMENT OF HEALTH AND time period, you will lose your right to on the attorney work product doctrine. HUMAN SERVICES further administrative review and your The attorney work product doctrine right to judicial review, unless you can would not protect the source’s opinions Food and Drug Administration show us that there was good cause for on the completed form, regardless of your failure to make a timely request for whether or not your representative used 21 CFR Part 14 review. the form in his or her analysis of your ■ 15. Revise § 416.1435 to read as [Docket No. FDA–2012–N–0218] claim or made handwritten notes on the face of the report. follows: Advisory Committee; Antiviral Drugs (c) Your responsibility. You must § 416.1435 Submitting evidence prior to a Advisory Committee; Termination inform us about or submit all evidence hearing before an administrative law judge. known to you that relates to whether or AGENCY: Food and Drug Administration, not you are blind or disabled. When you You should submit information or HHS. submit evidence received from another evidence as required by § 416.912 or any ACTION: Final rule. source, you must submit that evidence summary of the evidence to the administrative law judge with the SUMMARY: The Food and Drug in its entirety, unless you previously request for hearing or within 10 days Administration (FDA) is announcing the submitted the same evidence to us or we mstockstill on DSK4VPTVN1PROD with RULES after filing the request, if possible. Each termination of the Antiviral Drugs instruct you otherwise. If we ask you, party shall make every effort to ensure Advisory Committee. This document you must inform us about: that the administrative law judge removes the Antiviral Drugs Advisory (1) Your medical source(s); Committee from the Agency’s list of receives all of the evidence (see (2) Your age; § 416.912) or all of the evidence is standing advisory committees. (3) Your education and training; available at the time and place set for DATES: This rule is effective March 20, (4) Your work experience; the hearing. 2015. VerDate Sep<11>2014 18:21 Mar 19, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\20MRR1.SGM 20MRR1

Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 14839 FOR FURTHER INFORMATION CONTACT: Dated: March 16, 2015. of the SUPPLEMENTARY INFORMATION Michael Ortwerth, Advisory Committee Jill Hartzler Warner, section. Oversight and Management Staff, Food Associate Commissioner for Special Medical Docket: For access to the docket to and Drug Administration, 10903 New Programs. read background documents or Hampshire Ave., Bldg. 32, Rm. 5129, [FR Doc. 2015–06425 Filed 3–19–15; 8:45 am] objections received, go to http:// Silver Spring, MD 20993–0002, 301– BILLING CODE 4164–01–P www.regulations.gov and insert the 796–8220, FAX: 301–847–8640, or docket number, found in brackets in the Michael.Ortwerth@fda.hhs.gov. heading of this document, into the DEPARTMENT OF HEALTH AND ‘‘Search’’ box and follow the prompts SUPPLEMENTARY INFORMATION: The HUMAN SERVICES and/or go to the Division of Dockets Antiviral Drugs Advisory Committee Management, 5630 Fishers Lane, Rm. was established on October 7, 1980 (see Food and Drug Administration 1061, Rockville, MD 20852. 45 FR 79025, November 28, 1980). The Committee reviews and evaluates FOR FURTHER INFORMATION CONTACT: 21 CFR Part 73 Laura A. Dye, Center for Food Safety available data concerning the safety and effectiveness of marketed and [Docket No. FDA–2013–C–1008] and Applied Nutrition (HFS–265), Food investigational human drug products for and Drug Administration, 5100 Paint use in the treatment of acquired Listing of Color Additives Exempt Branch Pkwy., College Park, MD 20740– immune deficiency syndrome, human From Certification; Synthetic Iron 3835, 240–402–1275. immunodeficiency virus related Oxide SUPPLEMENTARY INFORMATION: illnesses, and other viral, fungal and AGENCY: Food and Drug Administration, I. Introduction mycobacterial infections. The HHS. Committee is no longer needed and was ACTION: Final rule. In a document published in the terminated on February 15, 2015. Federal Register of September 17, 2013 SUMMARY: The Food and Drug (78 FR 57105), we announced that we Under 5 U.S.C. 553(b)(3)(B) and (d) Administration (FDA or we) is had filed a color additive petition (CAP and 21 CFR 10.40(d) and (e), the Agency amending the color additive regulations 3C0298) submitted by Wm. Wrigley Jr. finds good cause to dispense with notice to provide for the expanded safe use of Company, c/o Exponent Inc., 1150 and public comment procedures and to synthetic iron oxide as a color additive Connecticut Ave. NW., Suite 1100, proceed to an immediate effective date to include use in soft and hard candy, Washington, DC 20036 (petitioner). The on this rule. Notice and public comment mints, and chewing gum. This action is petition proposed to amend the color and a delayed effective date are in response to a petition filed by Wm. additive regulations in § 73.200 unnecessary and are not in the public Wrigley Jr. Company (Wrigley). Synthetic Iron Oxide (21 CFR 73.200) by interest as this final rule merely DATES: This rule is effective April 21, expanding the safe use of synthetic iron removes the name of the Antiviral Drugs 2015. See section X for further oxide as a color additive to include use Advisory Committee from the list of information on the filing of objections. in soft and hard candy, mints, and standing advisory committees in Submit either electronic or written chewing gum. The petitioner requested § 14.100 (21 CFR 14.100). objections and requests for a hearing by that the proposed uses be permitted at Therefore, the Agency is amending April 20, 2015. levels consistent with current good § 14.100(c) as set forth in the regulatory manufacturing practice (GMP). The ADDRESSES: You may submit either text of this document. petition also proposed to lower the electronic or written objections and List of Subjects in 21 CFR Part 14 requests for a hearing, identified by specification limit for lead in synthetic Docket No. FDA–2013–C–1008, by any iron oxide for human food use from 10 Administrative practice and of the following methods: milligrams per kilogram (mg/kg; 10 procedure, Advisory committees, Color parts per million (ppm)) to 5 mg/kg (5 additives, Drugs, Radiation protection. Electronic Submissions ppm). Submit electronic objections in the II. Background Therefore, under the Federal Food, following way: Drug, and Cosmetic Act and under Currently, synthetic iron oxides and • Federal eRulemaking Portal: http:// authority delegated to the Commissioner their hydrated forms are approved as www.regulations.gov. Follow the of Food and Drugs, 21 CFR part 14 is color additives for the following direct instructions for submitting comments. amended as follows: uses in human food, drugs, and Written Submissions cosmetics: (1) In sausage casings PART 14—PUBLIC HEARING BEFORE intended for consumption in an amount Submit written objections in the A PUBLIC ADVISORY COMMITTEE not exceeding 0.10 percent by weight of following ways: • Mail/Hand delivery/Courier (for the finished food (§ 73.200); (2) in ■ 1. The authority citation for 21 CFR paper submissions): Division of Dockets ingested or topically-applied drugs with part 14 continues to read as follows: Management (HFA–305), Food and Drug a limit for ingested drugs of 5 Authority: 5 U.S.C. App. 2; 15 U.S.C. Administration, 5630 Fishers Lane, Rm. milligrams, calculated as elemental iron, 1451–1461, 21 U.S.C. 41–50, 141–149, 321– 1061, Rockville, MD 20852. per day for labeled or prescribed 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 Instructions: All submissions received dosages (21 CFR 73.1200); and (3) in U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; must include the Docket No. FDA– cosmetics generally, including mstockstill on DSK4VPTVN1PROD with RULES Pub. L. 108–155; Pub. L. 113–54. 2013–C–1008 for this rulemaking. All cosmetics applied to the area of the eye, § 14.100 [Amended] objections received will be posted in amounts consistent with GMP (21 without change to http:// CFR 73.2250). ■ 2. Section 14.100 is amended by www.regulations.gov, including any Synthetically prepared iron oxides removing paragraph (c)(3) and personal information provided. For and their hydrated forms include red redesignating paragraphs (c)(4) through detailed instructions on submitting iron oxide, yellow iron oxide, black iron (18) as paragraphs (c)(3) through (17). objections, see the ‘‘Objections’’ heading oxide, and brown iron oxide, which is VerDate Sep<11>2014 18:21 Mar 19, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\20MRR1.SGM 20MRR1


Document Created: 2015-12-18 11:34:36
Document Modified: 2015-12-18 11:34:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective March 20, 2015.
ContactMichael Ortwerth, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301- 796-8220, FAX: 301-847-8640, or [email protected]
FR Citation80 FR 14838 
CFR AssociatedAdministrative Practice and Procedure; Advisory Committees; Color Additives; Drugs and Radiation Protection
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