General Rules and Regulations, Securities Act of 1933, 15841 [2011-6830]
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Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Rules and Regulations
SECURITIES AND EXCHANGE
COMMISSION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
17 CFR Part 230
Food and Drug Administration
General Rules and Regulations,
Securities Act of 1933
21 CFR Part 179
[Docket No. FDA–1999–F–0056; Formerly
Docket No. 1999F–4372]
CFR Correction
In Title 17 of the Code of Federal
Regulations, Parts 200 to 239, revised as
of April 1, 2010, on page 686, in
§ 230.501, following paragraph (e)(3),
reinstate the Note to paragraph (e) to
read as follows:
§ 230.501 Definitions and terms used in
Regulation D.
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*
*
*
*
(e) * * *
NOTE: The issuer must satisfy all the
other provisions of Regulation D for all
purchasers whether or not they are
included in calculating the number of
purchasers. Clients of an investment
adviser or customers of a broker or
dealer shall be considered the
‘‘purchasers’’ under Regulation D
regardless of the amount of discretion
given to the investment adviser or
broker or dealer to act on behalf of the
client or customer.
*
*
*
*
*
[FR Doc. 2011–6830 Filed 3–21–11; 8:45 am]
BILLING CODE 1505–01–D
Irradiation in the Production,
Processing, and Handling of Food;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Final rule; denial of requests for
a stay of effective date and for a hearing;
response to objections; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is denying
requests for a hearing on the final rule
that amended the food additive
regulations to provide for the safe use of
ionizing radiation for the control of
Vibrio species and other foodborne
pathogens in fresh or frozen molluscan
shellfish. After reviewing objections to
the final rule and requests for a hearing,
FDA has concluded that the objections
do not justify a hearing or otherwise
provide a basis for revoking the
regulation. FDA also is denying the
request for a stay of the effective date of
the amendment to the food additive
regulations.
SUMMARY:
DEPARTMENT OF THE TREASURY
The August 16, 2005, effective
date for the final rule published at 70 FR
48057 is confirmed.
FOR FURTHER INFORMATION CONTACT:
Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS–
255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1204.
SUPPLEMENTARY INFORMATION:
19 CFR Part 141
Table of Contents
DATES:
DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
Entry of Merchandise
CFR Correction
In Title 19 of the Code of Federal
Regulations, Parts 141 to 199, revised as
of April 1, 2010, on page 6, the second
general authority citation for part 141 is
removed.
Emcdonald on DSK2BSOYB1PROD with RULES
[FR Doc. 2011–6840 Filed 3–21–11; 8:45 am]
BILLING CODE 1505–01–D
VerDate Mar<15>2010
16:42 Mar 21, 2011
Jkt 223001
I. Introduction
II. Objections, Requests for a Hearing, and
Requests for a Stay
III. Standards for Granting a Hearing
IV. Analysis of Objections and Response to
Hearing Requests
A. Studies on Animals Fed Clams
B. Microbiological Safety of Molluscan
Shellfish
C. Reasonable Certainty of No Harm
D. Factors Unique to Molluscan Shellfish
E. Application of 100-Fold Safety Margin
for 2-Alkylcyclobutanones
F. Alleged Rejection of Published Evidence
G. Alleged Warnings on Potential Risks
H. Alleged Failure to Follow Critical
Guidelines for Food Additives
I. Wholesomeness
J. FDA Review Memoranda
K. Chemicals Formed in Irradiated Foods
V. Summary and Conclusion
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15841
VI. References
I. Introduction
FDA published a notice in the Federal
Register of October 19, 1999 (64 FR
56351), announcing the filing of a food
additive petition (FAP 9M4682) by the
National Fisheries Institute and the
Louisiana Department of Agriculture
and Forestry. In the Federal Register of
August 16, 2005 (70 FR 48057), FDA
issued a final rule permitting the
irradiation of fresh or frozen molluscan
shellfish for the control of Vibrio spp.
and other food-borne pathogens. FDA
based its decision on data in the petition
and in its files. In the preamble to the
final rule, FDA outlined the basis for its
decision and responded to questions
raised in several comments from Public
Citizen and the Center for Food Safety
(PC/CFS). The preamble to the final rule
advised that objections to the final rule
and requests for a hearing were due
within 30 days of the publication date
(i.e., by September 15, 2005).
II. Objections, Requests for a Hearing,
and Requests for a Stay
Section 409(f)(1) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 348(f)(1)) provides that,
within 30 days after publication of an
order relating to a food additive
regulation, any person adversely
affected by such order may file
objections, specifying with particularity
the provisions of the order ‘‘deemed
objectionable, stating reasonable
grounds therefore, and requesting a
public hearing upon such objections.’’
Under part 171 (21 CFR part 171) in
§ 171.110 of the food additive
regulations, objections and requests for
a hearing are governed by part 12 (21
CFR part 12) of FDA’s regulations.
Under § 12.22(a), each objection must
meet the following conditions: (1) Must
be submitted on or before the 30th day
after the date of publication of the final
rule; (2) must be separately numbered;
(3) must specify with particularity the
provision of the regulation or proposed
order objected to; (4) must specifically
state each objection on which a hearing
is requested; failure to request a hearing
on an objection constitutes a waiver of
the right to a hearing on that objection;
and (5) must include a detailed
description and analysis of the factual
information to be presented in support
of the objection if a hearing is requested;
failure to include a description and
analysis for an objection constitutes a
waiver of the right to a hearing on that
objection.
Following publication of the final rule
permitting the irradiation of fresh or
frozen molluscan shellfish for the
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[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Rules and Regulations]
[Page 15841]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6830]
[[Page 15841]]
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SECURITIES AND EXCHANGE COMMISSION
17 CFR Part 230
General Rules and Regulations, Securities Act of 1933
CFR Correction
In Title 17 of the Code of Federal Regulations, Parts 200 to 239,
revised as of April 1, 2010, on page 686, in Sec. 230.501, following
paragraph (e)(3), reinstate the Note to paragraph (e) to read as
follows:
Sec. 230.501 Definitions and terms used in Regulation D.
* * * * *
(e) * * *
NOTE: The issuer must satisfy all the other provisions of
Regulation D for all purchasers whether or not they are included in
calculating the number of purchasers. Clients of an investment adviser
or customers of a broker or dealer shall be considered the
``purchasers'' under Regulation D regardless of the amount of
discretion given to the investment adviser or broker or dealer to act
on behalf of the client or customer.
* * * * *
[FR Doc. 2011-6830 Filed 3-21-11; 8:45 am]
BILLING CODE 1505-01-D
