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Federal Register / Vol. 71, No.

139 / Thursday, July 20, 2006 / Rules and Regulations 41125

Optional Method of Compliance for TPE331 pigments as color additives in ingested each objection must meet the following
Series Engines Installed On Single-Engine drugs. After reviewing the objections, conditions: (1) Must be submitted on or
Airplanes the agency has concluded that the before the 30th day after the date of
(l) As an optional method of compliance to objections do not raise issues of material publication of the final rule, (2) must be
paragraph (h), (i), or (j) of this AD, for fact that justify a hearing or otherwise separately numbered, (3) must specify
TPE331 series engines installed on single- provide a basis for revoking the with particularity the provision of the
engine airplanes, having an affected amendment to the regulations. FDA is regulation or proposed order objected
Woodward FCU assembly perform the
also establishing a new effective date for to, (4) must specifically state the
following steps as necessary:
(1) Continue repetitive dimensional this color additive regulation, which provision of the regulation or proposed
inspections of the fuel control drive, for wear was stayed by the filing of objections. order on which a hearing is requested
or damage as specified in paragraph (g)(1) of DATES: The final rule that published in (failure to request a hearing on an
this AD. the Federal Register of July 22, 2005 objection constitutes a waiver of the
(2) Repair or replace the fuel pump or FCU (the July 2005 final rule) (70 FR 42271), right to a hearing on that objection), and
assembly if the splines fail the dimensional with an effective date of August 23, (5) must include a detailed description
inspection, with any serviceable fuel pump and analysis of the factual information
or FCU assembly.
2005, was stayed by the filing of
objections as provided for under section to be presented in support of the
Terminating Action 701(e)(2) of the Federal Food, Drug, and objection if a hearing is requested
(m) Performing an FCU assembly Cosmetic Act (the act) (21 U.S.C. (failure to include a description and
replacement as specified in paragraph (h), (i), 371(e)(2)) as of August 22, 2005. This analysis for an objection constitutes a
or (j) of this AD, is terminating action for the final rule is newly effective as of July waiver of the right to a hearing on that
initial and repetitive inspections required by 20, 2006. objection).
this AD. Following publication of the final rule
FOR FURTHER INFORMATION CONTACT:
for the use of mica-based pearlescent
Alternative Methods of Compliance Aydin Örstan, Center for Food Safety pigments to color ingested drugs, FDA
(n) The Manager, Los Angeles Aircraft and Applied Nutrition (HFS–255), Food received two submissions within the 30-
Certification Office, has the authority to and Drug Administration, 5100 Paint day objection period. One submission
approve alternative methods of compliance Branch Pkwy., College Park, MD 20740,
for this AD if requested using the procedures
objected to the use of pearlescent
301–436–1301. pigments in food. The submission did
found in 14 CFR 39.19.
SUPPLEMENTARY INFORMATION: not request a hearing.
Related Information The second submission objected to
I. Introduction
(o) Information pertaining to operating the final rule on three grounds: (1) The
recommendations for applicable engines after In the July 2005 final rule, FDA subject pearlescent pigments would
a fuel control drive failure is contained in OI amended the color additive regulations have iron contaminants, (2) these iron
331–12R5 dated July 10, 2006, for multi- to provide for the safe use of mica-based contaminants would cause stability
engine airplanes and in OI 331–18R3 dated pearlescent pigments prepared from issues for active ingredients in drugs,
July10, 2006, for single-engine airplanes. synthetic iron oxide, mica, and titanium and (3) the use of iron-containing
Issued in Burlington, Massachusetts, on dioxide to color ingested drugs. The pearlescent pigments to color drugs
July 14, 2006. preamble to the final rule advised that would limit the availability of
Francis A. Favara, objections to the final rule and requests medications for those who are
Manager, Engine and Propeller Directorate, for a hearing were due by August 22, monitoring their iron intake. This
Aircraft Certification Service. 2005, and that the rule would be submission requested a hearing on these
[FR Doc. E6–11540 Filed 7–19–06; 8:45 am] effective on August 23, 2005, except that issues.
BILLING CODE 4910–13–P any provisions may be stayed by the
filing of proper objections. III. Standards for Granting a Hearing
Specific criteria for determining
II. Objections and Requests for a whether to grant or deny a request for
DEPARTMENT OF HEALTH AND Hearing a hearing are set out in § 12.24(b). Under
HUMAN SERVICES
Sections 701(e)(2) and 721(d) of the that regulation, a hearing will be granted
Food and Drug Administration act (21 U.S.C. 371(e)(2) and 379e(d)) if the material submitted by the
collectively provide that, within 30 days requester shows, among other things,
21 CFR Part 73 after publication of an order relating to that: (1) There is a genuine and
a color additive regulation, any person substantial factual issue for resolution at
[Docket No. 1998C–0431] (formerly 98C– adversely affected by such an order may a hearing (a hearing will not be granted
0431) file objections, ‘‘specifying with on issues of policy or law); (2) the
particularity the provisions of the order factual issue can be resolved by
Listing of Color Additives Exempt
deemed objectionable, stating the available and specifically identified
From Certification; Mica-Based
grounds therefor, and requesting a reliable evidence (a hearing will not be
Pearlescent Pigments
public hearing upon such objections.’’ granted on the basis of mere allegations
AGENCY: Food and Drug Administration, FDA may deny a hearing request if the or denials or general descriptions of
HHS. objections to the regulation do not raise positions and contentions); (3) the data
ACTION: Final rule; response to genuine and substantial issues of fact and information submitted, if
objections; removal of stay. that can be resolved at a hearing (21 established at a hearing, would be
CFR 12.24(b)(1)). (See also Community adequate to justify resolution of the
SUMMARY: The Food and Drug Nutrition Institute v. Young, 773 F.2d factual issue in the way sought by the
Administration (FDA) is responding to requester (a hearing will be denied if the
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1356, 1364 (D.C. Cir. 1985), cert. denied,


two objections that it received on the 475 U.S. 1123 (1986).) data and information submitted are
final rule that amended the color Objections and requests for a hearing insufficient to justify the factual
additive regulations to provide for the are governed by part 12 (21 CFR part 12) determination urged, even if accurate);
safe use of mica-based pearlescent of FDA’s regulations. Under § 12.22(a), (4) resolution of the factual issue in the

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41126 Federal Register / Vol. 71, No. 139 / Thursday, July 20, 2006 / Rules and Regulations

way sought by the person is adequate to question in a material way the drugs, not foods. The objection to the
justify the action requested (a hearing underpinnings of the regulation at use of pearlescent pigments in food is
will not be granted on factual issues that issue’’ (Pactra Industries v. CPSC, 555 outside the scope of the July 2005 final
are not determinative with respect to the F.2d 677 (9th Cir. 1977)). Finally, courts rule. Therefore, FDA is denying this
action requested, e.g., if the action have uniformly recognized that a objection.
would be the same even if the factual hearing need not be held to resolve The second submission asserted that
issue were resolved in the way sought); questions of law or policy (see Citizens the subject pearlescent pigments would
(5) the action requested is not for Allegan County, Inc. v. FPC, 414 be contaminated with iron salts and that
inconsistent with any provision in the F.2d 1125 (D.C. Cir. 1969); Sun Oil Co. these contaminants would cause
act or any regulation particularizing v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. stability issues for active ingredients in
statutory standards (the proper denied, 358 U.S. 872 (1958)). drugs that could interfere with drug
procedure in those circumstances is for Even if the objections raise material efficacy. The submission also asserted
the person requesting the hearing to issues of fact, FDA need not grant a that the iron contaminants would
petition for an amendment or waiver of hearing if those same issues were increase exposure to iron. Furthermore,
the regulation involved); and (6) the adequately raised and considered in an the submission was concerned that the
requirements in other applicable earlier proceeding. Once an issue has use of iron-containing pearlescent
regulations, e.g., 21 CFR 10.20, 12.21, been raised and considered, a party is pigments to color drugs would limit the
12.22, 314.200, 514.200, and 601.7(a), estopped from raising the same issue in availability of medications for those
and in the notice issuing the final a later proceeding without new who are monitoring their iron intake.
regulation or the notice of opportunity evidence. The various judicial doctrines This submission requested a hearing on
for a hearing are met. dealing with finality can be validly these issues.
A party seeking a hearing is required applied to the administrative process. In Although this submission claimed
to meet a ‘‘threshold burden of explaining why these principles ‘‘self- that the subject pearlescent pigments
tendering evidence suggesting the need evidently’’ ought to apply to an agency would be contaminated with iron salts,
for a hearing’’ (Costle v. Pacific Legal proceeding, the U.S. Court of Appeals the submission did not provide any
Foundation, 445 U.S. 198, 214–215 for the District of Columbia Circuit factual information to support this
(1980), reh. denied, 446 U.S. 947 (1980), wrote: ‘‘The underlying concept is as claim. The July 2005 final rule was in
citing Weinberger v. Hynson, Westcott & simple as this: Justice requires that a response to a color additive petition
Dunning, Inc., 412 U.S. 609, 620–621 party have a fair chance to present his (CAP 8C0257) that FDA had received
(1973)). An allegation that a hearing is position. But overall interests of from the manufacturer of the subject
necessary to ‘‘sharpen the issues’’ or to administration do not require or pearlescent pigments. During its review
‘‘fully develop the facts’’ does not meet generally contemplate that he will be of the petition, FDA determined what
this test (Georgia Pacific Corp. v. EPA, given more than a fair opportunity.’’ specifications would be necessary to
671 F.2d 1235, 1241 (9th Cir. 1982)). If Retail Clerks Union, Local 1401 v. ensure the safe use of pearlescent
a hearing request fails to identify any NLRB, 463 F.2d 316, 322 (D.C. Cir. pigments in ingested drugs and
factual evidence that would be the 1972). (See also Costle v. Pacific Legal incorporated these specifications in the
subject of a hearing, there is no point in Foundation, supra at 215–220; Pacific new § 73.1128 (21 CFR 73.1128). FDA
holding one. In judicial proceedings, a Seafarers, Inc. v. Pacific Far East Line, also reviewed the results of analyses of
court is authorized to issue summary Inc., 404 F.2d 804 (D.C. Cir. 1968), cert. several batches of pearlescent pigments
judgment without an evidentiary denied, 393 U.S. 1093 (1969).) and determined that they complied with
hearing whenever it finds that there are In summary, a hearing request must the specifications in the new regulation.
no genuine issues of material fact in present sufficient credible evidence to In the preamble to the final rule, FDA
dispute, and a party is entitled to raise a material issue of fact, and the discussed the manufacturing process of
judgment as a matter of law (see Rule evidence must be adequate to resolve the subject pearlescent pigments. FDA
56, Federal Rules of Civil Procedure). the issue as requested and to justify the noted that the starting materials for
The same principle applies to action requested. these pigments included soluble iron
administrative proceedings (see § 12.28). One of the objections to the final rule salts and that the manufacturing
A hearing request must not only on mica-based pearlescent pigments did incorporated a heating (calcination) step
contain evidence, but that evidence not request a hearing. Therefore, FDA at temperatures up to 900 °C. FDA also
should raise a material issue of fact will rule upon the objection under noted that during calcination, the
concerning whether a meaningful §§ 12.24 through 12.28 (as cited in starting iron salts are converted into
hearing might be held (Pineapple § 12.30(b)). iron oxide.
Growers Association v. FDA, 673 F.2d The submission also asserted that the
1083, 1085 (9th Cir. 1982)). Where the IV. Analysis of Objections iron contaminants would destabilize
issues raised in the objection are, even FDA addresses each of the two active ingredients in drugs, which
if true, legally insufficient to alter the submissions in the following would affect drug efficacy. As noted
decision, the agency need not grant a paragraphs, as well as the evidence and previously in this document, the
hearing (see Dyestuffs and Chemicals, information filed in support of each, submission did not provide any factual
Inc. v. Flemming, 271 F.2d 281 (8th Cir. comparing each submission and the information to support the claim that
1959), cert. denied, 362 U.S. 911 information submitted in support of it to the subject pearlescent pigments would
(1960)). FDA need not grant a hearing in the standards for ruling on objections contain iron contaminants.
each case where an objector submits and granting a hearing in § 12.24. The third assertion in the submission
additional information or posits a novel The first submission objected to the was that the iron oxide in the subject
interpretation of existing information use of pearlescent pigments in food. pearlescent pigments is ‘‘expected to
This submission did not request a limit availability of medications for the
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(see United States v. Consolidated


Mines & Smelting Co., 455 F.2d 432 (9th hearing. FDA notes that the final rule persons who must monitor iron intake.’’
Cir. 1971)). In other words, a hearing is that is the subject of the objection However, the submission did not
justified only if the objections are made provides for the safe use of mica-based provide any factual information to
in good faith and if they ‘‘draw in pearlescent pigments to color ingested support this claim. FDA notes that, as

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Federal Register / Vol. 71, No. 139 / Thursday, July 20, 2006 / Rules and Regulations 41127

indicated in the preamble to the July regulation by establishing a new comment to the direct final rule; this
2005 final rule, the bioavailability of effective date of July 20, 2006 for this comment recommended a number of
these pigments and/or their individual regulation listing mica-based clarifications to the original ROPS
components when ingested is expected pearlescent pigments prepared from standards published in the direct final
to be low. synthetic iron oxide, mica, and titanium rule. In the present notice, the Agency
This submission did not provide any dioxide to color ingested drugs. As is making corrections and technical
factual information to modify FDA’s announced in the July 22, 2005, final amendments to the ROPS standards in
conclusion that the subject pearlescent rule, the previous effective date of the response to this comment, as a result of
pigments present no toxic potential regulation was August 23, 2005. editorial errors found in the ROPS
when ingested at levels estimated by the Therefore, under sections 701 and 721 standards published in the direct final
agency, based on their proposed use in of the act, notice is given that the rule, and to improve consistency among
coloring ingested drugs. Namely, this objections filed in response to the July the figures generated for these
submission did not provide specifically 2005 final rule do not form the basis for standards. The Agency finds that these
identified reliable evidence that can further stay of this final rule or require corrections and technical amendments
lead to resolution of a factual issue in amendment of the regulations. do not change the substantive
dispute (§ 12.24(b)(2)). A hearing will Accordingly, the stay of § 73.1128 that requirements of the ROPS standards.
not be granted on the basis of mere FDA is announcing in this document is
allegations or denials or general DATES:The corrections and technical
removed effective July 20, 2006. amendments specified by this
descriptions of positions and
contentions (§ 12.24(b)(2)). Therefore, List of Subjects in 21 CFR Part 73 rulemaking become effective on July 20,
FDA is denying this objection. 2006.
Color additives, Cosmetics, Drugs,
V. Summary and Conclusions Medical devices. FOR FURTHER INFORMATION CONTACT:

The agency is denying the objections ■ Therefore, under the Federal Food, Press inquiries: Kevin Ropp, OSHA
to the final rule in the two submissions Drug, and Cosmetic Act (21 U.S.C. 321, Office of Communications, Room N–
received on the following bases. The 341, 342, 343, 348, 351, 352, 355, 361, 3647, U.S. Department of Labor, 200
objection to the use of pearlescent 362, 371, 379e) and under authority Constitution Avenue, NW., Washington,
pigments in food is outside the scope of delegated to the Commissioner of Food DC 20210; telephone: (202) 693–1999.
the July 2005 final rule, which amended and Drugs (section 1410.10 of the FDA General and technical information:
the color additive regulations to provide Staff Manual Guide), notice is given that Matthew Chibbaro, Acting Director,
for the safe use of mica-based objections and a request for a hearing Office of Safety Systems, Directorate of
pearlescent pigments to color ingested were filed in response to the July 22, Standards and Guidance, Occupational
drugs. The objections in the second 2005, final rule. Notice is also given that Safety and Health Administration, U.S.
submission that the subject pearlescent the agency is denying these objections. Department of Labor, Room N–3609,
pigments would contain iron Accordingly, the amendments issued 200 Constitution Avenue, NW.,
contaminants, that the iron thereby are effective July 20, 2006. Washington, DC 20210; telephone (202)
contaminants would cause stability Dated: July 14, 2006. 693–2255.
issues for active ingredients in drugs, Jeffrey Shuren, SUPPLEMENTARY INFORMATION: On
and that the use of the pigments to color Assistant Commissioner for Policy. December 29, 2005, OSHA published a
ingested drugs will limit availability of [FR Doc. E6–11536 Filed 7–19–06; 8:45 am] direct final rule in the Federal Register
medications for the persons who must BILLING CODE 4160–01–S reinstating its original construction and
monitor their iron intake, are not agriculture standards that regulate the
supported by any factual information. testing of roll-over protective structures
The filing of the objections served to
DEPARTMENT OF LABOR (‘‘ROPS’’) used to protect employees
stay automatically the effectiveness of
who operate wheel-type tractors (see 70
§ 73.1128. Section 701(e)(2) of the act
Occupational Safety and Health FR 76979). The Agency received only
states: ‘‘Until final action upon such
Administration one public comment (Ex. 3–1) on the
objections is taken by the Secretary
direct final rule, which it determined
* * *, the filing of such objections shall
29 CFR Parts 1926 and 1928 was not a significant adverse comment.
operate to stay the effectiveness of those
The commenter recommended several
provisions of the order to which the [Docket No. S–270–A]
objections are made.’’ Section 701(e)(3) clarifications to the ROPS standards
RIN 1218–AC15 published in the direct final rule.
of the act further stipulates that ‘‘As
soon as practicable * * *, the Secretary The table below describes the
Roll-Over Protective Structures
shall by order act upon such objections clarifications recommended by the
and make such order public.’’ AGENCY: Occupational Safety and Health commenter who responded to the direct
The agency has completed its Administration (OSHA), Labor. final rule, and OSHA’s response to these
evaluation of the objections and ACTION: Final rule; corrections and recommendations. This response
concludes that a continuation of the stay technical amendments. provides the Agency’s rationale for
of this regulation is not warranted. accepting a recommendation or
In the absence of any other objections SUMMARY: On December 29, 2005, OSHA excluding it from further consideration.
and requests for a hearing, the agency, published a direct final rule in the Accordingly, OSHA is making a number
therefore, further concludes that this Federal Register reinstating its original of corrections and technical
document constitutes final action on the construction and agriculture standards amendments to the ROPS standards for
objections received in response to the that regulate the testing of roll-over construction (§ 1926.1002) and
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regulation as prescribed in section protective structures (‘‘ROPS’’) used to agriculture (§§ 1928.52 and 1928.53)
701(e)(2) of the act. Therefore, the protect employees who operate wheel- based on the commenter’s
agency is acting to end the stay of the type tractors. OSHA received one recommendations.

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