36020 Federal Register / Vol. 70, No.

119 / Wednesday, June 22, 2005 / Rules and Regulations

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* * * * * Correction to Final Rule (OMB) approval of the information

Issued in Washington, DC, on June 16, collection requirement in the final rule
■ Accordingly, pursuant to the authority
2005. published on June 29, 2004 (FR 69
delegated to me, the legal description for
Edith V. Parish, 39292). This notice also provides the
J–133, as published in the Federal
Acting Manager, Airspace and Rules.
amendment numbers for the final rule
Register on May 6, 2005 (70 FR 23934),
that were absent when it was published.
[FR Doc. 05–12366 Filed 6–21–05; 8:45 am] on page 23934 and incorporated by
BILLING CODE 4910–13–P reference in 14 CFR 71.1, is corrected as DATES : Final rule; Aircraft Assembly
follows: Placard Requirement was published in
the Federal Register on June 29, 2004.
DEPARTMENT OF TRANSPORTATION PART 71—[AMENDED] FAA received OMB approval for the
information collection requirement on
Federal Aviation Administration § 71.1 [Amended] November 8, 2004. The final rule
Paragraph 2004—Jet Airways becomes effective June 22, 2005.
14 CFR Part 71 FOR FURTHER INFORMATION CONTACT: Gary
* * * * *
[Docket No. FAA–2004–19851; Airspace Davis, Flight Standards Service, Air
Docket No. 04–AAL–13] J–133 [Corrected] Transportation Division, AFS–201A,
J–133: From Sitka, AK NDB; via INT Federal Aviation Administration, 800
RIN 2120–AA66 Independence Avenue SW.,
Sitka, AK NDB 308° and Orca Bay, AK,
Modification and Revocation of Federal NDB 114°; Orca Bay, AK; Johnstone Washington, DC 20591; telephone (202)
Airways; AK Point, AK; Anchorage, AK; to Galena 267–8166; facsimile (202) 267–5229; e-
AK. mail: gary.davis@faa.gov.
AGENCY: Federal Aviation SUPPLEMENTARY INFORMATION:
* * * * *
Administration (FAA), DOT.
ACTION: Final rule; correction. Issued in Washington, DC, on June 10, Background
2005.
On June 29, 2004, the FAA published
SUMMARY: This action corrects an error Edith V. Parish, the Final Rule, Aircraft Assembly
in the airspace description of a notice of Acting Manager, Airspace and Rules. Placard Requirements, as instructed by
a final rule that was published in the [FR Doc. 05–12126 Filed 6–21–05; 8:45 am] an act of Congress. The rule instructed
Federal Register on May 6, 2005 (70 FR BILLING CODE 4910–13–P affected air carriers to display a placard
23934), Airspace Docket No. 04–AAL– with information on where the aircraft
13. was assembled. We instructed air
DATES: Effective Date: 0901 UTC, July 7, DEPARTMENT OF TRANSPORTATION carriers to provide that information in
2005. one sentence on the seat-pocket cards
Federal Aviation Administration that inform passengers of emergency
FOR FURTHER INFORMATION CONTACT: Ken
McElroy, Airspace and Rules, Office of procedures.
14 CFR Parts 121 and 135 As noted in the preamble, the final
System Operations and Safety, Federal
Aviation Administration, 800 [Docket No. FAA–2004–18477; Amendment rule would not become effective until
Independence Avenue, SW., Nos. 121–312; 135–98] the FAA received approval from OMB
Washington, DC 20591; telephone: (202) for the information collection that was
267–8783. Aircraft Assembly Placard required in the rule. In the DATES section
Requirements of the final rule, we said that when that
SUPPLEMENTARY INFORMATION:
AGENCY: Federal Aviation approval was received we would
History publish a notice in the Federal Register
Administration, DOT.
On May 6, 2005, Airspace Docket No. ACTION: Final rule; Notice of Office of announcing the effective date.
04–AAL–13, was published in the Management and Budget approval for In accordance with the Paperwork
Federal Register (70 FR 23934), revising information collection and addition of Reduction Act, OMB approved the
Jet Route 133 (J–133), AK. In that rule, amendment numbers. FAA’s request for new information
the airspace description was collection on November 8, 2004. Please
incomplete. This action corrects that SUMMARY: This notice announces the note that an agency may not conduct or
error. Office of Management and Budget’s sponsor, and a person is not required to

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 Federal Register / Vol. 70, No. 119 / Wednesday, June 22, 2005 / Rules and Regulations
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
number associated with this collection
is 2120–0691. The request was approved
by OMB without change and expires on
November 30, 2007.
Additionally, the Final Rule was
published without amendment
numbers. This notice adds those
amendment numbers as shown in the
heading.
49 U.S.C. 106(g), 40113, 40119, 41706,
44101, 44701–44702, 44705, 44709–
44711, 44713, 44716–44717, 44722,
46105, grants authority to the
Administrator to publish this notice.
The final rule (FR 69 39292) is effective
immediately.
Issued in Washington, DC, on June 15,
2005.
Anthony F. Fazio,
Director, Office of Rulemaking.
[FR Doc. 05–12239 Filed 6–17–05; 11:35 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 2002F–0160]
Food Additives Permitted for Direct
Addition to Food for Human
Consumption; Vitamin D3
AGENCY: Food and Drug Administration,
HHS.
Final rule; correcting
ACTION:
amendments.
SUMMARY: The Food and Drug
Administration (FDA) is responding to
objections and is denying requests that
it has received for a hearing on the final
rule that amended the food additive
regulations authorizing the use of
vitamin D3 as a nutrient supplement in
calcium-fortified fruit juices and fruit
drinks, excluding fruit juices and fruit
juice drinks specially formulated or
processed for infants, at levels not to
exceed 100 International Units (IU) per
serving. (In the final rule, FDA used the
term ‘‘fruit drink;’’ however, the
common or usual name of the product
is ‘‘fruit juice drink.’’ Therefore, FDA is
replacing the term ‘‘fruit drink’’ with
‘‘fruit juice drink.’’) In response to one
of the objections, FDA is amending the
vitamin D3 regulation to replace the
current 100 IU per serving limits on the
vitamin D3 fortification of fruit juices
and fruit juice drinks with limits of 100
IU per 240 milliliters (mL). This
VerDate jul<14>2003 15:52 Jun 21, 2005 Jkt 205001
document also corrects three errors that
appeared in the codified portion of the
vitamin D3 final rule.
DATES: This rule is effective June 22,
2005. Submit written or electronic
objections and requests for a hearing by
July 22, 2005. See section IX of this
document for information on the filing
of objections.
ADDRESSES: You may submit written or
electronic objections and requests for a
hearing, identified by Docket No.
2002F–0160, by any of the following
methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: http://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov.
Include Docket No. 2002F–0160 in the
subject line of your e-mail message.
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD-ROM 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 agency name and
docket number for this rulemaking. All
objections received will be posted
without change to http://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
objections received, go to http://
www.fda.gov/ohrms/dockets/
default.htm 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:
Judith L. Kidwell, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1071.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of April 25,
2002 (67 FR 20533), FDA published a
notice announcing the filing of a food
additive petition (FAP 2A4734) by the
Minute Maid Co. (Minute Maid), to
amend the food additive regulations in
PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\22JNR1.SGM
36021
part 172 Food Additives Permitted for
Direct Addition to Food for Human
Consumption (21 CFR part 172) to
provide for the safe use of vitamin D3 as
a nutrient supplement in calcium-
fortified fruit juices and fruit juice
drinks. In response to FAP 2A4734, in
the Federal Register of February 27,
2003 (68 FR 9000), FDA issued a final
rule permitting the safe use of vitamin
D3 as a nutrient supplement in calcium-
fortified fruit juices and fruit juice
drinks1, excluding fruit juices and fruit
juice drinks specially formulated or
processed for infants, at levels not to
exceed 100 IU per serving. This
regulation was codified in § 172.380.
FDA based its decision on data
contained in the petition and in its files.
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, by
March 31, 2003. FDA received several
submissions within the 30-day objection
period. Some of the submissions sought
revocation of the final rule and
requested a hearing. In response to one
of the objections received during the 30-
day objection period, FDA is amending
the food additive regulation to replace
those portions of the vitamin D3
regulation that prescribe limits on
vitamin D3 fortification of fruit juices
and fruit juice drinks of 100 IU per
serving with limits of 100 IU per 240
mL. This document also corrects three
errors that appeared in the codified
portion of the vitamin D3 final rule.
II. Objections and Requests for a
Hearing
Section 409(f) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(f)), 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 [based]
upon such objections.’’ FDA may deny
a hearing request if the objections to the
regulation do not raise genuine and
substantial issues of fact that can be
resolved at a hearing.
Under 21 CFR 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
1 In the final rule (68 FR 9000), FDA used the
term ‘‘fruit drink.’’ In 21 CFR 102.33, the common
or usual name of the product is ‘‘fruit juice drink.’’
To be consistent with § 102.33, FDA is replacing the
term ‘‘fruit drink’’ with ‘‘fruit juice drink’’ in
§ 172.380(d) and elsewhere in this document.
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