Proposed Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008, 35410-35412 [E8-14108]

Download as PDF 35410 Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices DEPARTMENT OF JUSTICE General, Environment and Natural Resources Division, and either emailed to pubcomment-ees.enrd@usdoj.gov or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611, and should refer to United States v. John Woodhams, D.J. Ref. 90– 11–3–09038. The Decree may be examined at the Office of the United States Attorney, District of North Dakota, 655 First Avenue North, Suite 250, Fargo, ND 58102–4932, and at U.S. EPA Region 8, 1595 Wynkoop St., Denver, CO 80202– 1129. During the public comment period, the Decree, may also be examined on the following Department of Justice Web site, https:// www.usdoj.gov/enrd/ Consent_Decrees.html. A copy of the Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, D.C. 20044–7611 or by faxing or e-mailing a request to Tonia Fleetwood (tonia.fleetwood@usdoj.gov), fax no. (202) 514–0097, phone confirmation number (202) 514–1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $6.25 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by email or fax, forward a check in that amount to the Consent Decree Library at the stated address. Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Robert D. Brook, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8–14056 Filed 6–20–08; 8:45 am] filed on time and was accompanied by all the rentals due since the date the lease terminated under the law. FOR FURTHER INFORMATION CONTACT: Bureau of Land Management, Pamela J. Lewis, Chief, Branch of Fluid Minerals Adjudication, at (307) 775–6176. SUPPLEMENTARY INFORMATION: The lessee has agreed to the amended lease terms for rentals and royalties at rates of $10.00 per acre, or fraction thereof, per year and 162⁄3 percent, respectively. The lessee has paid the required $500 administrative fee and $163 to reimburse the Department for the cost of this Federal Register notice. The lessee has met all the requirements for reinstatement of the lease as set out in Sections 31(d) and (e) of the Mineral Lands Leasing Act of 1920 (30 U.S.C. 188), and the Bureau of Land Management is proposing to reinstate lease WYW173501 effective December 1, 2007, under the original terms and conditions of the lease and the increased rental and royalty rates cited above. BLM has not issued a valid lease affecting the lands. Pamela J. Lewis, Chief, Branch of Fluid Minerals Adjudication. [FR Doc. E8–14155 Filed 6–20–08; 8:45 am] mmaher on PROD1PC70 with NOTICES BILLING CODE 4310–22–P Notice is hereby given that on June 17, 2008, a proposed Consent Decree (‘‘Decree’’) in United States v. John Woodhams, Civil Action No. 3:07–CV– 0074–RRE–KKK was lodged with the United States District Court for the District of North Dakota. The Decree resolves the United States’ claims under Section 107 of the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9607, for reimbursement of response costs incurred in connection with the release or threatened release of hazardous substances at the Camelot Cleaners Site in West Fargo, North Dakota (‘‘Site’’). The Decree requires Defendant to pay $300,000 to the United States for response costs and assign to the United States all potential rights to insurance claim proceeds relating to the Site. The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the Decree. Comments should be addressed to the Assistant Attorney VerDate Aug<31>2005 01:51 Jun 21, 2008 Jkt 214001 BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Notice of Lodging of Settlement Agreement; Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that, for a period of 30 days, the United States will receive public comments on a proposed Consent Decree in United States v. Dravo Corporation (Civil Action No. 8:04–CV–356), which was lodged with the United States District Court for the District of Nebraska on June 16, 2008. The Complaint alleges that Dravo is civilly liable for violations under Section 107(a) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (‘‘CERCLA’’), 42 U.S.C. 9607(a). The Complaint seeks the recovery of response costs incurred and to be incurred by the United States as a result of releases or threatened PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 releases of hazardous substances at or from the Hastings Naval Ammunition Depot Subsite of the Hastings Ground Water Contamination Site, located in Hastings, Adams County, Nebraska. Under the settlement, Dravo Corporation has agreed to pay to the United States one million one hundred sixty-one thousand dollars ($1,161,000.00) for the recovery of these response costs. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and may be submitted to: P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611, or via e-mail to pubcomment-ees.enrd@usdoj.gov, and should refer to United States v. Dravo Corporation, D.J. Ref. 90–11–2–1260/2. The Consent Decree may be examined at the Office of the United States Attorney. District of Nebraska, 1620 Dodge Street, Suite 1400, Omaha, NE 68102–1506. During the public comment period the Dravo Consent Decree may also be examined on the following Department of Justice Web site: https://www.usdoj.gov/enrd/ Consent_Decrees.html. A copy of the Dravo Consent Decree also may be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611 or by faxing or e-mailing a request to Tonia Fleetwood (tonia.fleetwood@usdoj.gov), fax no. (202) 514–0097, phone confirmation number (202) 514–1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $4.25 (25 cents per page reproduction cost) payable to the U.S. Treasury. Maureen M. Katz, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8–14041 Filed 6–20–08; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–306R] Proposed Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008 Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed revised 2008 assessment of annual needs for the list I chemicals ephedrine, AGENCY: E:\FR\FM\23JNN1.SGM 23JNN1 35411 Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices pseudoephedrine, and phenylpropanolamine. SUMMARY: This notice proposes revised 2008 assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Written comments must be postmarked, and electronic comments must be sent, on or before July 23, 2008. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–306R’’ on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. However, persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307–7183. SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine Epidemic Act of 2005 (Title VII of Pub. L. 109–177) (CMEA) amended Section DATES: 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing language to read as follows: ‘‘The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.’’ Further, 715 of CMEA amended 21 U.S.C. 952 ‘‘Importation of controlled substances’’ by adding the same List I chemicals to the existing language in paragraph (a), and by adding a new paragraph (d) to read as follows: (a) Controlled substances in schedule I or II and narcotic drugs in schedule III, IV, or V; exceptions It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from any place outside thereof, any controlled substance in schedule I or II of Subchapter I of this chapter, or any narcotic drug in schedule III, IV, or V of Subchapter I of this chapter, or ephedrine, pseudoephedrine, and phenylpropanolamine, except that— (1) such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and phenylpropanolamine, as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes, and * * * * * (d)(1) With respect to a registrant under Section 958 who is authorized under subsection (a)(1) to import ephedrine, pseudoephedrine, or phenylpropanolamine, at any time during the year the registrant may apply for an increase in the amount of such chemical that the registrant is authorized to import, and the Attorney General may approve the application if the Attorney General determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical. Editor’s Note: This excerpt of the amendment is published for the convenience of the reader. The official text is published at 21 U.S.C. 952(a) and (d)(1). On December 27, 2007, a notice was published in the Federal Register which established the assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (72 FR 73361). Pursuant to 21 CFR 1315, the Deputy Administrator of the DEA will, in early 2008, adjust the assessment of annual needs and individual importing and manufacturing quotas allocated for the year based upon 2007 year-end inventory and 2007 disposition data supplied by quota recipients for ephedrine, pseudoephedrine, and phenylpropanolamine, and other information available to the DEA. The proposed revised 2008 assessment of annual needs represents those quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which may be manufactured domestically and/or imported into the United States to provide adequate supplies of each substance for: The estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes the following revised 2008 assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2008, expressed in grams of anhydrous base: Previously established initial 2008 assessment/ (kg) List I chemicals mmaher on PROD1PC70 with NOTICES Ephedrine (for sale) ................................................................................................................................................. Ephedrine (for conversion) ...................................................................................................................................... Pseudoephedrine (for sale) ..................................................................................................................................... Phenylpropanolamine (for sale) ............................................................................................................................... Phenylpropanolamine (for conversion) .................................................................................................................... All interested persons are invited to submit their comments in writing or electronically regarding this proposal VerDate Aug<31>2005 01:51 Jun 21, 2008 Jkt 214001 following the procedures in the section of this document. A person may object to or comment on the ADDRESSES PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 11,500 128,760 511,100 5,545 85,470 Proposed revised 2008 assessment/ (kg) 11,500 128,760 511,100 5,545 85,470 proposal relating to any of the abovementioned substances without filing comments or objections regarding the E:\FR\FM\23JNN1.SGM 23JNN1 35412 Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing as per 21 CFR 1315.13(e). Regulatory Certifications Regulatory Flexibility Act The Deputy Administrator hereby certifies that this action will not have a significant economic impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601–612. The establishment of the assessment of annual needs for ephedrine, pseudoephedrine and phenylpropanolamine is mandated by law. The assessments are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and the establishment and maintenance of reserve stocks. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis. Executive Order 12866 The Office of Management and Budget has determined that notices of assessment of annual needs are not subject to centralized review under Executive Order 12866. Executive Order 13132 This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132. mmaher on PROD1PC70 with NOTICES Executive Order 12988 This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Unfunded Mandates Reform Act of 1995 This action will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more VerDate Aug<31>2005 01:51 Jun 21, 2008 Jkt 214001 in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreignbased companies in domestic and export markets. Dated: June 6, 2008. Michele M. Leonhart, Deputy Administrator. [FR Doc. E8–14108 Filed 6–20–08; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA–2008–0020] Slings; Extension of the Office of Management and Budget’s (OMB) Approval of Information Collection (Paperwork) Requirements Occupational Safety and Health Administration (OSHA), Labor. ACTION: Request for public comment. AGENCY: SUMMARY: OSHA solicits comments concerning its proposal to extend OMB approval of the information collection requirements contained in the Standard on Slings (29 CFR 1910.184). The collection of information (paperwork) provisions of the Standard specify affixing identification tags or markings on slings, developing and maintaining inspection records, and retaining proof testing certificates. DATES: Comments must be submitted (postmarked, sent, or received) by August 22, 2008. ADDRESSES: Electronically: You may submit comments and attachments electronically at https:// www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for submitting comments. Facsimile: If your comments, including attachments, are not longer PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 than 10 pages, you may fax them to the OSHA Docket Office at (202) 693–1648. Mail, hand delivery, express mail, messenger, or courier service: When using this method, you must submit three copies of your comments and attachments to the OSHA Docket Office, Docket No. OSHA–2008–0020, U.S. Department of Labor, Occupational Safety and Health Administration, Room N–2625, 200 Constitution Avenue, NW., Washington, DC 20210. Deliveries (hand, express mail, messenger, and courier service) are accepted during the Department of Labor’s and Docket Office’s normal business hours, 8:15 a.m. to 4:45 p.m., e.t. Instructions: All submissions must include the Agency name and OSHA docket number for the ICR (OSHA– 2008–0020). All comments, including any personal information you provide, are placed in the public docket without change, and may be made available online at https://www.regulations.gov. For further information on submitting comments see the ‘‘Public Participation’’ heading in the section of this notice titled SUPPLEMENTARY INFORMATION. Docket: To read or download comments or other material in the docket, go to https://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket (including this Federal Register notice) are listed in the https:// www.regulations.gov index; however, some information(e.g., copyrighted material) is not publicly available to read or download through the Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. You may also contact Theda Kenney at the address below to obtain a copy of the ICR. FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, RoomN–3609, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693–2222. SUPPLEMENTARY INFORMATION: I. Background The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program E:\FR\FM\23JNN1.SGM 23JNN1

Agencies

[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Pages 35410-35412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14108]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-306R]


Proposed Revised Assessment of Annual Needs for the List I 
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2008 assessment of annual needs for 
the list I chemicals ephedrine,

[[Page 35411]]

pseudoephedrine, and phenylpropanolamine.

-----------------------------------------------------------------------

SUMMARY: This notice proposes revised 2008 assessment of annual needs 
for the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before July 23, 2008.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-306R'' on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 
22152. Comments may be directly sent to DEA electronically by sending 
an electronic message to dea.diversion.policy@usdoj.gov. However, 
persons wishing to request a hearing should note that such requests 
must be written and manually signed; requests for a hearing will not be 
accepted via electronic means. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file format other than those 
specifically listed here.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine 
Epidemic Act of 2005 (Title VII of Pub. L. 109-177) (CMEA) amended 
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) by 
adding ephedrine, pseudoephedrine, and phenylpropanolamine to existing 
language to read as follows: ``The Attorney General shall determine the 
total quantity and establish production quotas for each basic class of 
controlled substance in schedules I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine to be manufactured each 
calendar year to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks.'' Further, 715 of CMEA amended 21 U.S.C. 952 ``Importation of 
controlled substances'' by adding the same List I chemicals to the 
existing language in paragraph (a), and by adding a new paragraph (d) 
to read as follows:

    (a) Controlled substances in schedule I or II and narcotic drugs 
in schedule III, IV, or V; exceptions

    It shall be unlawful to import into the customs territory of the 
United States from any place outside thereof (but within the United 
States), or to import into the United States from any place outside 
thereof, any controlled substance in schedule I or II of Subchapter 
I of this chapter, or any narcotic drug in schedule III, IV, or V of 
Subchapter I of this chapter, or ephedrine, pseudoephedrine, and 
phenylpropanolamine, except that--

    (1) such amounts of crude opium, poppy straw, concentrate of 
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and 
phenylpropanolamine, as the Attorney General finds to be necessary 
to provide for medical, scientific, or other legitimate purposes, 
and

* * * * *
    (d)(1) With respect to a registrant under Section 958 who is 
authorized under subsection (a)(1) to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, at any time during the year 
the registrant may apply for an increase in the amount of such 
chemical that the registrant is authorized to import, and the 
Attorney General may approve the application if the Attorney General 
determines that the approval is necessary to provide for medical, 
scientific, or other legitimate purposes regarding the chemical.


    Editor's Note: This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 952(a) and (d)(1).


    On December 27, 2007, a notice was published in the Federal 
Register which established the assessment of annual needs for the List 
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (72 FR 
73361). Pursuant to 21 CFR 1315, the Deputy Administrator of the DEA 
will, in early 2008, adjust the assessment of annual needs and 
individual importing and manufacturing quotas allocated for the year 
based upon 2007 year-end inventory and 2007 disposition data supplied 
by quota recipients for ephedrine, pseudoephedrine, and 
phenylpropanolamine, and other information available to the DEA.
    The proposed revised 2008 assessment of annual needs represents 
those quantities of ephedrine, pseudoephedrine, and phenylpropanolamine 
which may be manufactured domestically and/or imported into the United 
States to provide adequate supplies of each substance for: The 
estimated medical, scientific, research, and industrial needs of the 
United States; lawful export requirements; and the establishment and 
maintenance of reserve stocks.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes the following revised 2008 assessment of annual needs for the 
List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine 
for 2008, expressed in grams of anhydrous base:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
            List I chemicals               initial 2008    revised 2008
                                            assessment/     assessment/
                                               (kg)            (kg)
------------------------------------------------------------------------
Ephedrine (for sale)....................          11,500          11,500
Ephedrine (for conversion)..............         128,760         128,760
Pseudoephedrine (for sale)..............         511,100         511,100
Phenylpropanolamine (for sale)..........           5,545           5,545
Phenylpropanolamine (for conversion)....          85,470          85,470
------------------------------------------------------------------------

    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the ADDRESSES section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding 
the

[[Page 35412]]

others. If a person believes that one or more of these issues warrant a 
hearing, the individual should so state and summarize the reasons for 
this belief. Persons wishing to request a hearing should note that such 
requests must be written and manually signed; requests for a hearing 
will not be accepted via electronic means. In the event that comments 
or objections to this proposal raise one or more issues which the 
Deputy Administrator finds warrant a hearing, the Deputy Administrator 
shall order a public hearing by notice in the Federal Register, 
summarizing the issues to be heard and setting the time for the hearing 
as per 21 CFR 1315.13(e).

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this action will not 
have a significant economic impact upon small entities whose interests 
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the assessment of annual needs for ephedrine, 
pseudoephedrine and phenylpropanolamine is mandated by law. The 
assessments are necessary to provide for the estimated medical, 
scientific, research and industrial needs of the United States, for 
lawful export requirements, and the establishment and maintenance of 
reserve stocks. Accordingly, the Deputy Administrator has determined 
that this action does not require a regulatory flexibility analysis.

Executive Order 12866

    The Office of Management and Budget has determined that notices of 
assessment of annual needs are not subject to centralized review under 
Executive Order 12866.

Executive Order 13132

    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.

Executive Order 12988

    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

Unfunded Mandates Reform Act of 1995

    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Congressional Review Act

    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: June 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E8-14108 Filed 6-20-08; 8:45 am]
BILLING CODE 4410-09-P
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