58974 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations 

§ 62.301 Payment of fees and other 

charges. 

Fees and other charges for QSVP 

services shall be paid in accordance 

with the following provisions. Upon 

receipt of billing for fees and other 

charges, the applicant shall remit 

payment within 10 business days by 

check, electronic funds transfer, draft, or 

money order made payable to USDA, 

AMS, in accordance with directions on 

the billing. Fees and charges shall be 

paid in advance if required by the 

auditor or other authorized USDA 

official. 

Miscellaneous 

OMB Control Number 

§ 62.400 OMB control number assigned 

pursuant to the Paperwork Reduction Act. 

The information collection and 

recordkeeping requirements of this part 

have been approved by OMB under 44 

U.S.C. Chapter 35 and have been 

assigned OMB Control Number 0581–

0124. 

Dated: October 4, 2005. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 05–20310 Filed 10–7–05; 8:45 am] 

BILLING CODE 3410–02–P 

SMALL BUSINESS ADMINISTRATION 

13 CFR Part 126 

RIN 3245–AF31 

HUBZone Program; Corrections 

AGENCY: U.S. Small Business 

Administration (SBA). 

ACTION: Correcting amendments. 

SUMMARY: The U.S. Small Business 

Administration (SBA) is correcting an 

improper citation within the interim 

rule that appeared in the Federal 

Register on August 30, 2005, which 

amends SBA’s HUBZone program 

regulations. 

DATES: Effective October 11, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Michael McHale, Associate 

Administrator, HUBZone Program, at 

(202) 205–6731 or by e-mail at: 

michael.mchale@sba.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On August 30, 2005, at 79 FR 51243, 

the SBA published an interim final rule 

amending SBA’s HUBZone, 8(a) 

Business Development, Government 

Contracting and Size Standard 

regulations. This rule implemented 

provisions of the Small Business Act 

including the Consolidated 

Appropriations Act, 2005, specifically, 

Subtitle E of Division K entitled the 

Small Business Reauthorization and 

Manufacturing Assistance Act of 2004. 

Need for Correction 

Since publication, SBA has 

discovered that this interim rule 

inadvertently stated SBA’s intent to 

revise § 126.306 (found at 70 FR 51250) 

when it should have cited specifically to 

§ 126.306(a). SBA intended to revise 

only subsection (a) leaving the other 

subsections unchanged. 

List of Subjects in 13 CFR Part 126 

Administrative practice and 

procedure, Government procurement, 

Small businesses. 

■ Accordingly, 13 CFR part 126 is 

corrected by making the following 

correcting amendments: 

PART 126—HUBZONE PROGRAM 

■ 1. The authority citation for part 126 

continues to read as follows: 

Authority: 15 U.S.C. 632(a), 632(j), 632(p) 

and 657a. 

■ 2. Revise the first and last sentences 

of § 126.306(a) as follows: 

§ 126.306 How will SBA process this 

certification? 

(a) The AA/HUB or designee is 

authorized to approve or decline 

certifications. * * * The decision of the 

AA/HUB or designee is the final agency 

decision. 

* * * * * 

Dated: September 30, 2005. 

Allegra McCullough, 

Associate Deputy Administrator/Office of 

Government Contracting and Business 

Development. 

[FR Doc. 05–20188 Filed 10–7–05; 8:45 am] 

BILLING CODE 8025–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 310 and 341 

[Docket No. 2004N–0289] 

RIN 0910–AF34 

Cold, Cough, Allergy, Bronchodilator, 

and Antiasthmatic Drug Products for 

Over-the-Counter Human Use; 

Amendment of Final Monograph for 

Over-the-Counter Nasal Decongestant 

Drug Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

final monograph (FM) for over-thecounter (OTC) nasal decongestant drug 

products (drug products used to relieve 

nasal congestion due to a cold, hay 

fever, or other upper respiratory 

allergies) to remove the indication ‘‘for 

the temporary relief of nasal congestion 

associated with sinusitis’’ and to 

prohibit use of the terms ‘‘sinusitis’’ and 

‘‘associated with sinusitis’’ elsewhere 

on the labeling. This final rule is part of 

FDA’s ongoing review of OTC drug 

products. 

DATES: Effective Date: This regulation is 

effective April 11, 2007. 

Compliance Dates: The compliance 

date for products with annual sales less 

than $25,000 is October 11, 2007. The 

compliance date for all other products is 

April 11, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Michael T. Benson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993, 301–796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 2, 

2004 (69 FR 46119), FDA published a 

proposed rule to amend the FM for OTC 

nasal decongestant drug products to 

remove the indication ‘‘for the 

temporary relief of nasal congestion 

associated with sinusitis’’ and to 

prohibit use of the terms ‘‘sinusitis’’ and 

‘‘associated with sinusitis’’ elsewhere 

on the labeling. Recent publications 

(Refs. 1 and 2) indicate that prospective 

studies on the role of nasal 

decongestants in the treatment of 

sinusitis are lacking, and the data on 

their use as an adjunct in the treatment 

of sinusitis are limited and 

controversial. Despite the lack of 

evidence for their use, nasal 

decongestants are recommended or 

prescribed by health care providers as 

adjunctive therapy for sinusitis. This 

treatment occurs within a physicianpatient relationship and should not be 

construed as evidence that consumers 

should self-diagnose and self-manage 

sinusitis. In addition, there is 

preclinical evidence that topical nasal 

decongestants may have a negative 

effect on the resolution of sinusitis, as 

they may increase the degree of sinus 

inflammation (Ref. 3). Due to the current 

labeling, FDA is concerned that 

consumers use OTC nasal decongestant 

drug products (both oral and topical) to 

treat symptoms associated with