Advisory Committee; Antiviral Drugs Advisory Committee; Termination, 14838-14839 [2015-06425]
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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;
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(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.
*
*
*
*
*
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:
■
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.
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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.
Subpart N—[Amended]
§ 416.1400
Subpart O—[Amended]
*
*
*
*
*
(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.
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.
SUMMARY:
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Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations
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.
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.
SUPPLEMENTARY INFORMATION:
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:
mstockstill on DSK4VPTVN1PROD with RULES
■
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).
■
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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.
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:
SUMMARY:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
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 https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
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14839
of the SUPPLEMENTARY INFORMATION
section.
Docket: For access to the docket to
read background documents or
objections received, go to https://
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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]]>Agencies
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Rules and Regulations]
[Pages 14838-14839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06425]
=======================================================================
-----------------------------------------------------------------------
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.
[[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 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 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
