14838 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 

eligible for benefits (see paragraph 

(b)(2)(iv) of this section). 

(iii) The provisions of paragraph 

(b)(2)(i) apply to communications 

between you and your non-attorney 

representative only if the 

communications would be subject to the 

attorney-client privilege, if your nonattorney representative were an 

attorney. The provisions of paragraph 

(b)(2)(ii) apply to the analysis of your 

claim by your non-attorney 

representative only if the analysis of 

your claim would be subject to the 

attorney work product doctrine, if your 

non-attorney representative were an 

attorney. 

(iv) The attorney-client privilege 

generally protects confidential 

communications between an attorney 

and his or her client that are related to 

providing or obtaining legal advice. The 

attorney work product doctrine 

generally protects an attorney’s analysis, 

theories, mental impressions, and notes. 

In the context of your disability claim, 

neither the attorney-client privilege nor 

the attorney work product doctrine 

allows you to withhold factual 

information, medical source opinions, 

or other medical evidence that we may 

consider in determining whether or not 

you are eligible for benefits. For 

example, if you tell your representative 

about the medical sources you have 

seen, your representative cannot refuse 

to disclose the identity of those medical 

sources to us based on the attorneyclient privilege. As another example, if 

your representative asks a medical 

source to complete an opinion form 

related to your impairment(s), 

symptoms, or limitations, your 

representative cannot withhold the 

completed opinion form from us based 

on the attorney work product doctrine. 

The attorney work product doctrine 

would not protect the source’s opinions 

on the completed form, regardless of 

whether or not your representative used 

the form in his or her analysis of your 

claim or made handwritten notes on the 

face of the report. 

(c) Your responsibility. You must 

inform us about or submit all evidence 

known to you that relates to whether or 

not you are blind or disabled. When you 

submit evidence received from another 

source, you must submit that evidence 

in its entirety, unless you previously 

submitted the same evidence to us or we 

instruct you otherwise. If we ask you, 

you must inform us about: 

(1) Your medical source(s); 

(2) Your age; 

(3) Your education and training; 

(4) Your work experience; 

(5) Your daily activities both before 

and after the date you say that you 

became disabled; 

(6) Your efforts to work; and 

(7) Any other factors showing how 

your impairment(s) affects your ability 

to work. In §§ 416.960 through 

416.969a, we discuss in more detail the 

evidence we need when we consider 

vocational factors. 

* * * * * 

Subpart N—[Amended] 

■ 13. The authority citation for subpart 

N of part 416 continues to read as 

follows: 

Authority: Secs. 702(a)(5), 1631, and 1633 

of the Social Security Act (42 U.S.C. 

902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 14. Amend § 416.1400 by revising 

paragraph (b) to read as follows: 

§ 416.1400 Introduction. 

* * * * * 

(b) Nature of the administrative 

review process. In making a 

determination or decision in your case, 

we conduct the administrative review 

process in an informal, non-adversarial 

manner. Subject to the limitations on 

Appeals Council consideration of 

additional evidence (see §§ 416.1470(b) 

and 416.1476(b)), we will consider at 

each step of the review process any 

information you present as well as all 

the information in our records. You may 

present the information yourself or have 

someone represent you, including an 

attorney. If you are dissatisfied with our 

decision in the review process, but do 

not take the next step within the stated 

time period, you will lose your right to 

further administrative review and your 

right to judicial review, unless you can 

show us that there was good cause for 

your failure to make a timely request for 

review. 

■ 15. Revise § 416.1435 to read as 

follows: 

§ 416.1435 Submitting evidence prior to a 

hearing before an administrative law judge. 

You should submit information or 

evidence as required by § 416.912 or any 

summary of the evidence to the 

administrative law judge with the 

request for hearing or within 10 days 

after filing the request, if possible. Each 

party shall make every effort to ensure 

that the administrative law judge 

receives all of the evidence (see 

§ 416.912) or all of the evidence is 

available at the time and place set for 

the hearing. 

Subpart O—[Amended] 

■ 16. The authority citation for subpart 

O of part 416 continues to read as 

follows: 

Authority: Secs. 702(a)(5), 1127, and 

1631(d) of the Social Security Act (42 U.S.C. 

902(a)(5), 1320a–6, and 1383(d)). 

■ 17. In § 416.1540, revise paragraphs 

(b)(1) and (b)(2)(i) through (vi) and add 

paragraph (b)(2)(vii) to read as follows: 

§ 416.1540 Rules of conduct and 

standards of responsibility for 

representatives. 

* * * * * 

(b) * * * 

(1) Act with reasonable promptness to 

help obtain the information or evidence 

that the claimant must submit under our 

regulations, and forward the 

information or evidence to us for 

consideration as soon as practicable. 

(2) * * * 

(i) The claimant’s medical source(s); 

(ii) The claimant’s age; 

(iii) The claimant’s education and 

training; 

(iv) The claimant’s work experience; 

(v) The claimant’s daily activities both 

before and after the date the claimant 

alleges that he or she became disabled; 

(vi) The claimant’s efforts to work; 

and 

(vii) Any other factors showing how 

the claimant’s impairment(s) affects his 

or her ability to work. In §§ 416.960 

through 416.969a, we discuss in more 

detail the evidence we need when we 

consider vocational factors; 

* * * * * 

[FR Doc. 2015–05921 Filed 3–19–15; 8:45 am] 

BILLING CODE 4191–02–P 

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. 

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. 

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Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 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 

Michael.Ortwerth@fda.hhs.gov. 

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 

§ 14.100 (21 CFR 14.100). 

Therefore, the Agency is amending 

§ 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 

■ 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. 

§ 14.100 [Amended] 

■ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2013–C–1008] 

Listing of Color Additives Exempt 

From Certification; Synthetic Iron 

Oxide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the color additive regulations 

to provide for the expanded safe use of 

synthetic iron oxide as a color additive 

to include use in soft and hard candy, 

mints, and chewing gum. This action is 

in response to a petition filed by Wm. 

Wrigley Jr. Company (Wrigley). 

DATES: This rule is effective April 21, 

2015. See section X for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing by 

April 20, 2015. 

ADDRESSES: You may submit either 

electronic or written objections and 

requests for a hearing, identified by 

Docket No. FDA–2013–C–1008, by any 

of the following methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–C–1008 for this rulemaking. All 

objections received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section. 

Docket: For access to the docket to 

read background documents or 

objections received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Laura A. Dye, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 240–402–1275. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In a document published in the 

Federal Register of September 17, 2013 

(78 FR 57105), we announced that we 

had filed a color additive petition (CAP 

3C0298) submitted by Wm. Wrigley Jr. 

Company, c/o Exponent Inc., 1150 

Connecticut Ave. NW., Suite 1100, 

Washington, DC 20036 (petitioner). The 

petition proposed to amend the color 

additive regulations in § 73.200 

Synthetic Iron Oxide (21 CFR 73.200) by 

expanding the safe use of synthetic iron 

oxide as a color additive to include use 

in soft and hard candy, mints, and 

chewing gum. The petitioner requested 

that the proposed uses be permitted at 

levels consistent with current good 

manufacturing practice (GMP). The 

petition also proposed to lower the 

specification limit for lead in synthetic 

iron oxide for human food use from 10 

milligrams per kilogram (mg/kg; 10 

parts per million (ppm)) to 5 mg/kg (5 

ppm). 

II. Background 

Currently, synthetic iron oxides and 

their hydrated forms are approved as 

color additives for the following direct 

uses in human food, drugs, and 

cosmetics: (1) In sausage casings 

intended for consumption in an amount 

not exceeding 0.10 percent by weight of 

the finished food (§ 73.200); (2) in 

ingested or topically-applied drugs with 

a limit for ingested drugs of 5 

milligrams, calculated as elemental iron, 

per day for labeled or prescribed 

dosages (21 CFR 73.1200); and (3) in 

cosmetics generally, including 

cosmetics applied to the area of the eye, 

in amounts consistent with GMP (21 

CFR 73.2250). 

Synthetically prepared iron oxides 

and their hydrated forms include red 

iron oxide, yellow iron oxide, black iron 

oxide, and brown iron oxide, which is 

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