[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Notices]
[Page 63491-63495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc08-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0549]
Opportunity for Hearing on a Proposal to Withdraw Approval of
Prescription Polyethylene Glycol 3350 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
withdraw approval of the following abbreviated new drug applications
(ANDAs) for drug products containing polyethylene glycol 3350 (PEG
3350) labeled for prescription only use: ANDA 76-652 held by Schwarz
Pharma, Inc.; ANDA 77-736 held by Kali Laboratories, Inc.; ANDA 77-706
held by Nexgen Pharma Inc. (formerly known as Anabolic Laboratories,
Inc.); ANDA 77-893 held by Coastal Pharmaceuticals, Inc.; and ANDA 77-
445 held by Teva Pharmaceutical Industries, Ltd. (collectively, the PEG
3350 ANDAs). The proposal is based on the switch of MiraLax from
prescription only (``Rx only'') to over-the-counter (OTC) use. This
switch was pursuant to the submission of a new drug application (NDA)
for MiraLax (NDA 22-015), which was approved by the agency on October
6, 2006, establishing that PEG 3350 may be used safely and effectively
without the supervision of a licensed healthcare professional. The
Federal Food, Drug, and Cosmetic Act (the act) does not permit both Rx
and OTC versions of the same drug product to be marketed at the same
time. Under the act, a drug to which the prescription provisions of the
act do not apply (i.e., an OTC drug) shall be deemed to be misbranded
if at any time prior to dispensing the label of the product bears the
``Rx only'' symbol. Because the PEG 3350 generic drug products are
labeled as Rx only, they are misbranded and may not be legally
marketed. Thus, FDA is proposing to withdraw their approval.
DATES: Submit written or electronic requests for a hearing by November
24, 2008; submit data and information in support of the hearing request
by December 23, 2008. Submit written or electronic comments by December
23, 2008.
ADDRESSES: Submit written requests for a hearing, any data and
information justifying a hearing, and any other comments identified
with Docket No. FDA-2008-N-0549 to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic requests for a hearing, any data
and information justifying a hearing, and any other comments identified
with Docket No. FDA-2008-N-0549 to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 10903
New Hampshire Ave., Bldg.51, rm. 6368, Silver Spring, MD 20993-0002,
301-796-3601.
SUPPLEMENTARY INFORMATION:
I. Background
A. Original Approval of MiraLax NDA and Subsequent ANDA Products
MiraLax is an osmotic laxative containing the active ingredient
polyethylene glycol 3350. MiraLax was approved as a prescription drug
on February 18, 1999, under Braintree Laboratories, Inc. (Braintree),
NDA 20-698, for up to 14 days of use for the treatment of occasional
constipation in adults. In patients with a history of constipation,
MiraLax therapy increases the volume and frequency of bowel movements.
The approved prescription dosing and administration regimen stated:
``The usual dose is 17 grams (about 1 heaping tablespoon)
of powder per day (or as directed by physician) in 8 ounces of water.
Each bottle of MiraLax is supplied with a measuring cap marked to
contain 17 grams of laxative powder when filled to the indicated line.
Two to 4 days (48 to 96 hours) may be required to produce
a bowel movement.''
Five ANDAs for PEG 3350 powder for oral solution, 17 gram (g)/
single-dose were subsequently submitted and approved based on this
reference-listed drug MiraLax Powder for Oral Solution for Rx only use.
These ANDAs were approved under the requirements of section 505(j) of
the act (21 U.S.C. 355(j)) and Sec. Sec. 314.92 and 314.94 (21 CFR
314.92 and 314.94). The approved labeling of these PEG 3350 ANDA
products is the same as that of the reference-listed drug, NDA 20-698.
B. Switch of Innovator Product
On October 6, 2006, FDA approved a new NDA for MiraLax (NDA 22-015)
submitted by Braintree, switching its use from Rx only to OTC. By
approving this NDA, FDA determined that PEG 3350 may be used safely and
effectively OTC for the treatment of occasional constipation and that
the Rx only limitation on PEG 3350 for occasional constipation was no
longer necessary or appropriate. The sponsor was granted 3 years of
exclusivity based on the studies necessary to establish that PEG 3350
would be safe and effective when used OTC for the treatment of
occasional constipation. According to FDA's Approved Drug Products With
Therapeutic Equivalence Evaluations, NDA 22-015 is the subject of
marketing exclusivity for the OTC use of MiraLax until October 6, 2009.
Schering-Plough Corp. now holds NDA 22-015 and markets its PEG 3350
product for OTC use under the brand name MiraLax[reg].
C. The Durham-Humphrey Amendments
The distinction between prescription and OTC drugs was codified by
the Durham-Humphrey Amendments, which were enacted in order to address
the marketplace confusion that arose from the simultaneous marketing of
identical or nearly identical drugs on a prescription and OTC basis for
identical or equivalent uses (Public Law 82-215, 65 Stat. 648 (1951).
See, e.g., H.R. Rep. No. 82-700, at 5 (1951); see also 70 FR 52050 at
52051, September 1, 2005). Prescription drugs are defined as those
which because of their toxicity or other potentiality for harmful
effect, or the method of use, or the collateral measures necessary to
their use, are not safe for use except under the supervision of a
practitioner licensed to administer such drugs, or those drugs which
are limited by an approved application under section 505 of the act
[[Page 63492]]
to use under the professional supervision of a practitioner licensed to
administer such drugs (see section 503(b)(1) of the act). A drug that
does not meet this definition is an OTC drug.
The Durham-Humphrey Amendments prohibit marketing both Rx and OTC
versions of the same drug product at the same time (21 U.S.C. 353(b)).
Under section 503(b)(4)(B) of the act, a drug to which the prescription
provisions of the act do not apply (i.e., an OTC drug) shall be deemed
to be misbranded if at any time prior to dispensing the label of the
drug bears the ``Rx only'' symbol. Once FDA determines that the
prescription provisions of the act in section 503(b)(1) (21 U.S.C.
353(b)(1)) do not apply a manufacturer is expressly prohibited from
labeling the drug product as prescription only for the OTC uses under
section 503(b)(4)(B) of the act. Specifically, such labeling would
cause the drug to be misbranded under section 503(b)(4)(B) of the act.
Under section 301(a) of the act (21 U.S.C. 331(a)), it is a prohibited
act to introduce a misbranded drug product into interstate commerce.
These provisions of the Durham-Humphrey Amendments apply to the PEG
3350 drug products. PEG 3350 was initially approved as a prescription
product under the requirements of section 503(b)(1) in NDA 20-698
submitted by Braintree. The PEG 3350 ANDAs were approved based on
reference to NDA 20-698 and FDA's determination that the products
covered by the ANDAs contained the same active ingredient; were in the
same dosage form, strength, and route of administration; and had the
same labeling as the Braintree product. In approving NDA 22-015, FDA
determined that MiraLax is safe and effective for OTC use and that the
prescription provisions of section 503(b)(1) of the act no longer
apply. Thus, no manufacturer of a PEG 3350 product that is the same as
the OTC drug product can market its product for Rx only use under
section 503(b)(4)(B) of the act. The manufacturers of PEG 3350 products
approved in ANDAs that referenced NDA 20-698 are prohibited by sections
301(a) and 503(b)(4)(B) of the act from labeling their PEG 3350
products as Rx only for marketing in interstate commerce.
D. FDA's Notice to the PEG 3350 ANDA Holders
On April 20, 2007, FDA sent to the five sponsors of the approved
PEG 3350 ANDAs letters that articulated the agency's position regarding
the legality of marketing of PEG 3350 for Rx use. FDA's letters
explained that section 503(b) of the act does not permit both Rx and
OTC versions of the same drug product to be marketed at the same time.
FDA's letters informed the ANDA holders that their Rx products, which
bear the ``Rx only'' symbol, are misbranded and may not be legally
marketed. FDA's letters further explained that if an ANDA holder wished
to continue marketing its product, the company must submit a new ANDA
using the appropriate reference listed drug, NDA 22-015, and that such
ANDA, among other things, must include the same OTC labeling as the
reference listed drug.
The letters noted that the sponsors could not simply supplement
their existing ANDAs because section 505(j)(2)(D)(i) of the act does
not allow an applicant to amend or supplement an application by
referring to a different listed drug.
E. Grounds for Withdrawal Under the Standard of Section 505(e) of the
Act
1. Statutory Authority
Section 505(e) of the act states that the Secretary of Health and
Human Services (the Secretary) may, after due notice and opportunity
for hearing to the applicant, withdraw the approval of an application
if the Secretary finds that ``on the basis of new information * * * the
labeling of such drug, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of.'' As stated previously,
FDA sent letters on April 20, 2007, to the five sponsors of the
approved PEG 3350 ANDAs informing them that their Rx products, which
bear the ``Rx only'' symbol of the reference listed drug product in NDA
20-698, are misbranded under section 503(b)(4)(B) of the act and may
not be legally marketed because the same PEG 3350 drug as the reference
listed drug was approved as safe and effective for OTC use in NDA 22-
015. Thus, in accordance with section 505(e) of the act, the ANDA
holders have been given written notice that the Rx only labeling for
their drugs is false and misleading, because FDA has determined that
the drug product may be used safely and effectively OTC. The sponsors
have failed to submit new ANDAs using the appropriate reference listed
drug, NDA 22-015, including, among other things, the same OTC labeling
as the reference listed drug. In addition, the applicants have not
voluntarily sought withdrawal of the approval of their respective
ANDAs.
Therefore, FDA is proceeding with this notice of opportunity for a
hearing on the agency's proposal to withdraw approval of these ANDAs
for the Rx only PEG 3350 products. As explained previously, FDA is
basing this proposal to withdraw approval under section 505(e) of the
act on the ``false and misleading'' labeling of the Rx only products,
which are misbranded under section 503(b)(4)(B) of the act because they
bear the ``Rx only'' symbol and the same PEG 3350 product was approved
for OTC use.
2. The Rx and OTC Products Are the Same Drug Under Section 503(b) of
the Act
In determining whether an Rx drug product and an OTC drug product
are the same, FDA considers whether there are any meaningful
differences between the OTC and Rx products that would justify the
different marketing status of the products. When considering whether a
drug switched from prescription to nonprescription status differs from
the prescription drug in some meaningful way, the agency considers such
factors as the indication, strength, route of administration, dosage
form, or patient population (see 70 FR 52050 at 52051, September 1,
2005). If there are no meaningful differences between the Rx version of
the drug and the OTC version of the drug that would support the
continued marketing of the Rx version of the drug, the drug with the Rx
labeling is misbranded under section 503(b)(4)(B) of the act.
The agency has determined that there is no meaningful difference
between the Rx and OTC PEG 3350 drug products. There is no meaningful
difference between the PEG 3350 prescription drug product that was
approved under NDA 20-698 and the PEG 3350 switched to OTC status under
NDA 22-015, nor is there a meaningful difference between the ANDAs
referencing the PEG 3350 prescription drug product under NDA 20-698 and
the OTC PEG 3350 product under NDA 22-015. There are no meaningful
differences between the Rx and OTC products in any of the factors
considered when evaluating meaningful differences, including the active
ingredient, dosage form, strength, route of administration,
indications, or patient population. The active ingredient in both drug
products is polyethylene glycol 3350. Each is a powder for solution
which is to be taken orally once daily by dissolving a 17-g dose in 4
to 8 ounces of liquid. Both drugs are indicated for use in patients
with constipation. Finally, both drugs are for patients 17 years of age
or older. Thus, these products are the same. The
[[Page 63493]]
continued marketing of the same PEG 3350 drug product on both a
prescription and nonprescription basis could result in the consumer
confusion that Congress intended section 503(b)(4)(B) of the act to
prevent.
3. Nonmeaningful Label Differences
As explained previously, NDA 20-068 and NDA 22-015 are the same
drug for purposes of determining Rx/OTC status under section
503(b)(4)(B) of the act. There are, however, minor differences in the
labeling between the Rx and OTC drugs that are based on the agency's
practice under the OTC drug monograph system of having consistent
labeling for lawfully marketed OTC laxative drugs. These differences
are not meaningful for purposes of determining the appropriateness of
continued Rx marketing under section 503(b)(4)(B) of the act.
Specifically, there are minor, nonmeaningful differences in
duration of use and in the wording of the indication between the Rx and
OTC products.\1\ The labeling of NDA 20-068 states: ``For the treatment
of occasional constipation. This product should be used for 2 weeks or
less as directed by a physician.'' The NDA 22-015 (MiraLax OTC) label
states: ``Relieves occasional constipation (irregularity). Generally
produces a bowel movement in 1-3 days.'' Also, the MiraLax OTC label
states: ``Use no more than 7 days.''
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\1\ There have been numerous instances in which a drug has been
switched from Rx to OTC status and there has been a change in its
duration of use (e.g., ranitidine). In these cases, the drug
remained prescription for one duration of use while becoming OTC for
the other duration of use only when there was an additional and more
fundamental difference between the products, such as a different
indication, dose, duration of therapy, and/or target population.
Often these drugs are initially approved as Rx and then subsequently
switched to OTC for certain indications with corresponding different
durations of use. The Rx version of the drug continues to be
marketed with indications for which consumers cannot self-diagnose
and treat the disease or condition, requiring physician supervision.
The manner in which a particular drug is dosed or administered
(e.g., dose titration, duration of use) may also require clinical
judgment and physician supervision, and thus Rx status, while a
corresponding OTC version of the drug can be available at a
different dosing regimen or duration of use that does not require
physician involvement. Therefore, for the Rx and OTC versions of
other drugs (e.g., omeprazole, ibuprofen), there are meaningful
differences that are distinguishable from the nonmeaningful
differences between the Rx version (NDA 22-068) and the OTC version
(NDA 22-015) of MiraLax.
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These minor variations in labeling statements are not based on any
differences in use necessitated by science or safety concerns, but
rather are based on differences inherent in all OTC laxative drugs. The
7-day duration of use for OTC laxatives is derived from advice from the
advisory panel convened over 3 decades ago, when they considered
appropriate labeling for laxatives to be regulated under the OTC
Monograph for Laxative Drug Products for OTC Human Use (40 FR 12902 at
12906, March 21, 1975). The panel noted a concern about the safety of
labeling nonprescription laxatives for longer than 1 week, noting that
a consistent message regarding duration of use of OTC laxatives (for a
maximum of 7 days) helps to promote safety in case the consumer is
constipated from a serious condition for which he or she should seek
care from a physician. Also, the consistency of OTC laxative labeling
for the maximum 7-day duration of use helps to avoid consumer confusion
regarding how long to use different laxative products.
In addition, the Tentative Final Monograph for Laxative Drug
Products for OTC Human Use (50 FR 2124, January 15, 1985) uses the
phrase ``For the relief of occasional constipation'' in the labeled
indication statement. Thus, FDA approved the OTC MiraLax drug with a
similar indication statement (relieves occasional constipation) for
consistency with other OTC marketed laxative products. As noted
previously, the consistency of OTC laxative labeling helps to avoid any
consumer confusion that might arise from differences in wording of the
indication statement between OTC laxative products. The limited
duration of use and use of the word ``relieves'' instead of
``treatment'' are factors inherent to all OTC laxative products and do
not demonstrate a meaningful difference between a specific OTC drug and
an Rx drug.
The Rx-to-OTC switch of MiraLax was a full switch of the same drug
for the same indication. The differences in labeling for the duration
of use and the words ``relieves'' and ``treatment'' exist because of
the need for OTC labeling statements across OTC laxative products to be
consistent. These minor changes to the MiraLax labeling for OTC use do
not constitute a meaningful difference for purposes of section
503(b)(4)(B) of the act. If such differences in labeling were
considered meaningful, no Rx and OTC laxative drug would be considered
the same, and the prohibition of section 503(b)(4)(B) of the act would
never apply to these products, and thus would be meaningless. Thus,
there are no meaningful differences between the PEG 3350 Rx and OTC
drugs or their indications.
4. Same Safety and Efficacy Profiles
Moreover, the data in the MiraLax OTC NDA did not demonstrate there
is a difference between the safety and efficacy profiles of the Rx and
OTC drugs. To support its original NDA 20-698 for the Rx marketing of
MiraLax, the sponsor submitted study data that demonstrated that the
drug was safe and effective for Rx use. In patients with a history of
constipation, FDA determined that MiraLax therapy increases the volume
and frequency of bowel movements. To support its NDA 22-015 for an Rx-
to-OTC switch of the MiraLax drug, the sponsor submitted three studies
evaluating the safety and efficacy of the drug in adults (including a
subset of elderly subjects) for a period longer than the previously-
approved period of up to 14 days of use. Although OTC MiraLax is
indicated for a period of up to 1 week, the submitted long-term safety
studies allowed for a better assessment of whether the drug would be
safe in the OTC environment, where repeated purchase and use is likely.
The primary endpoints for these three studies were all longer term
assessments of safety and efficacy and not the day to first bowel
movement.
The following summaries describe the studies that formed the basis
for approval for NDA 20-698, MiraLax (PEG 3350).
Study 851-3 was a single center, double-blind, triple-
crossover, study which randomized 50 constipated patients to a first
period (10 days) of either 17 or 34 g of PEG 3350 therapy.
Subsequently, without a washout interval, subjects were randomized to
second or third periods (also 10 days) of placebo or the alternate PEG
3350 dose. The primary endpoints of efficacy were stool frequency and
stool weight. All 50 patients completed this trial. This study helped
to define a dose-response for PEG 3350.
Study 851-6 was a double-blind, parallel trial which
enrolled 151 subjects who were randomized to placebo or PEG 3350 17 g.
The treatment period lasted 14 days. The primary efficacy endpoint was
bowel movement frequency with success defined as >3 bowel movements per
7-day period, and failure defined as <3 bowel movements per 7-day
period, use of a laxative or enema or withdrawal from the study. One
hundred thirty three subjects completed this study.
The studies submitted with NDA 22-015 to support the Rx to OTC
switch are briefly described as follows:
Study 851-CR1 was a randomized, double-blind, placebo-
controlled, multicenter study of 304 subjects comparing 6 months of
treatment with PEG 3350 17 g/day to daily treatment with a matched
placebo.
Study 851-CR3 was an open-label, long term, multicenter
study of 311
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subjects using PEG 3350 17 g/day for 12 months.
Study 851-ZCC was an open-label, randomized, parallel arm,
multicenter study of constipated adult patients randomized to treatment
with either 17 g/day PEG 3350 or Zelnorm (tegaserod maleate) for 28
days.
Eligible subjects were constipated, but otherwise healthy, adults
with no documented organic cause for constipation who met protocol-
specified modified Rome Criteria for constipation. (Rome criteria are
consensus criteria developed by the Rome Coordinating Committee (RCC)
on various medical topics.) In study 851-CR3, all subjects were treated
with MiraLax. In study 851-CR1, subjects who met study criteria were
randomized 2:1 to PEG or placebo treatment. In study 851-ZCC, subjects
were randomized 1:1 to PEG or Zelnorm. The primary endpoint(s) for
these three studies were all longer term assessments of efficacy and
safety and not the day to first bowel movement.
There was no suggestion in any of the reviews that the drug MiraLax
would act any differently in the OTC consumer than in a patient who
would have previously taken the drug by a physician's prescription.
There was no data in the three studies submitted in the OTC switch
application that showed a different efficacy or safety profile in the
treated populations. The three studies provided evidence that MiraLax
would be safe if repeatedly used over time in an OTC setting. When
considering the data from study 851-ZCC in conjunction with other
efficacy data, one could reasonably conclude that MiraLax, whether a
prescription or OTC drug, is efficacious for the vast majority of users
with constipation within 7 days and generally produces a bowel movement
by day 3. This information enabled FDA to inform consumers about the
expectation of benefit on the OTC label.
Based on its review of the study data for the Rx-to-OTC switch of
MiraLax, FDA concluded that there was no indication that the MiraLax
drug would act differently in the OTC consumer than in a patient who
took the drug by a physician's prescription. In particular, there was
no data in the three studies submitted in the OTC switch application
that showed a different efficacy or safety profile between the
populations taking the OTC drug and those taking an Rx drug. The three
studies provided sufficient evidence that MiraLax would be safe if
repeatedly used over time in an OTC setting. FDA concluded that OTC
MiraLax is efficacious for the vast majority of users with constipation
within 7 days and generally produces a bowel movement by day 3.
5. NDA 20-698, NDA 22-015, and the PEG 3350 ANDAs Are the Same Drug
The fact that FDA approved the MiraLax OTC drug under a different
NDA (22-015) than the MiraLax Rx NDA (20-698) does not demonstrate that
there is a meaningful difference between the MiraLax Rx and OTC drugs.
The data in the MiraLax OTC NDA did not demonstrate any differences
between the safety and efficacy profiles of the Rx and OTC drugs.
Whether the sponsor sought an Rx-to-OTC switch of the drug through a
supplement to the original NDA, or by submission of a separate NDA, is
a reflection of the sponsor's choice and administrative processes
within the agency, and is irrelevant in determining whether the Rx and
OTC products are the same for the purpose of section 503(b)(4)(B) of
the act. The content of the applications to support such a switch would
be the same, regardless of the form of the applications. All of the
approved indications in NDA 20-698 were switched to OTC uses in 22-015.
As explained previously, there are no meaningful differences
between the drug approved in NDA 20-698 and NDA 22-015. With the
exception of slight differences in labeling necessitated by the OTC
switch, they are the same drug for purposes of section 503(b) of the
act. Under section 503(b)(4)(B), the innovator (Schering-Plough Corp.)
cannot legally market the misbranded Rx drug product that had been
approved in NDA 20-698. Therefore, the manufacturers of the PEG 3350 Rx
drugs approved in ANDAs, which are the same as the reference listed Rx
drug approved in NDA 20-698, are also prohibited from marketing their
misbranded Rx drugs.
II. Notice of Opportunity for a Hearing
The Director has evaluated the information discussed previously
and, on the grounds stated, is proposing to withdraw approval of ANDA
76-652, ANDA 77-736, ANDA 77-706, ANDA 77-893, ANDA 77-445 and all
amendments and supplements thereto, on the ground that the drugs
covered by the applications are misbranded and the labeling for such
drugs is false and misleading.
In accordance with section 505 of the act and part 314 (21 CFR part
314), notice is given to the sponsors of the PEG 3350 ANDAs, and to all
other interested persons, that FDA is hereby providing the applicants
an opportunity to request a hearing to show why the applications listed
should not be withdrawn.
Any applicant who decides to seek a hearing shall file: (1) On or
before November 24, 2008, a written notice of appearance and request
for a hearing and (2) on or before December 23, 2008, the data,
information, and analyses relied on to demonstrate that there is a
genuine and substantial issue of material fact that requires a hearing
to resolve, as specified in Sec. 314.200.
Any other interested person may also submit comments on this notice
on or before December 23, 2008. The procedures and requirements
governing this notice of opportunity for a hearing, notice of
participation and request for a hearing, information and analyses to
justify a hearing, other comments, and a grant or denial of a hearing
are contained in Sec. 314.200 and in 21 CFR part 12.
The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that applicant not to avail itself of the
opportunity to request a hearing concerning the action proposed and
constitutes a waiver of any contentions concerning the legal status of
that applicant's drug products. In such instance FDA intends to
withdraw approval of the applications and to take other appropriate
action. Any new drug product marketed without an approved new drug
application is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of material fact that requires a hearing.
If it conclusively appears from the face of the data, information, and
factual analyses in the request that there is no genuine and
substantial issue of material fact, or if a request for a hearing is
not made in the required format or with the required analyses, the
Commissioner of Food and Drugs will enter summary judgment against the
person who requests the hearing, making findings and conclusions, and
denying a hearing.
All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 63495]]
Dated: October 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25359 Filed 10-23-08; 8:45 am]
BILLING CODE 4160-01-S