This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

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REGISTER issue of each week.

Rules and Regulations Federal Register

58969 

Vol. 70, No. 195 

Tuesday, October 11, 2005 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Parts 54 and 62 

[No. LS–02–10] 

RIN 0581–AC12 

Quality Systems Verification Programs 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: The Agricultural Marketing 

Service (AMS) is establishing a separate 

user-fee schedule for the Quality 

Systems Verification Programs (QSVP) 

and expanding the scope of the QSVP to 

include all agricultural products and 

services within the responsibility of the 

Livestock and Seed (LS) Program. A 

new part 62 is established for QSVP 

services. QVSP are a collection of 

voluntary, audit-based, user-fee 

programs authorized under the 

Agricultural Marketing Act of 1946. 

QSVP facilitate the global marketing and 

trade of agricultural products; provide 

consumers the opportunity to 

distinguish specific characteristics 

involved in the production and 

processing of agricultural products; and 

ensure that product consistently meets 

program requirements. 

DATES: Effective October 25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

James L. Riva, Chief, Audit, Review, and 

Compliance (ARC) Branch, telephone 

202–720–1124, or e-mail 

James.Riva@usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background and Discussion 

The Agricultural Marketing Act of 

1946 (AMA), as amended, (7 U.S.C. 

1621, et seq.), gives AMS the authority 

to provide services so that agricultural 

products may be marketed to their best 

advantage, that trade may be facilitated, 

and that consumers may be able to 

ascertain characteristics involved in the 

production and processing of products 

and obtain the quality of product they 

desire. AMA also provides for the 

collection of fees from users of these 

services that are reasonable and cover 

the cost of providing services. 

The QSVP were developed in 1995 

and have since grown to include several 

value-added marketing programs. The 

QSVP have grown steadily over the past 

few years, with auditors conducting 385 

assessments in fiscal year (FY) 2001, 

562 assessments in FY 2002, and 715 

assessments in FY 2003, and 915 

assessments in FY 2004. Presently, 14 

full’time auditors conduct assessments 

for the LS Program. 

QSVP are voluntary, audit-based, 

user-fee funded programs developed 

and conducted at the request of industry 

and others as a cost-effective alternative 

to conventional product certification. 

QSVP use International Organization for 

Standardization’s (ISO) Guidelines and 

standards as a format for evaluating 

program documentation to ensure 

consistent assessment practices and 

promote international recognition of 

assessment results. 

QSVP user-fees were previously based 

on the approved hourly rate established 

for meat grading and certification 

services provided by the Meat Grading 

and Certification (MGC) Branch 

pursuant to 7 CFR part 54. Following 

the initial program development period, 

LS Program management conducted a 

detailed cost analysis of QSVP services 

and determined that the existing hourly 

rate established for meat grading and 

certification services did not sufficiently 

cover the cost of providing QSVP 

services. Due to the complexity of 

planning, performing and interpreting 

the results of assessments, auditor 

positions are classified at the GS–11/12 

pay grade, in contrast to the GS–5/7/9 

pay grade classifications of most MGC 

Branch full-time positions. 

Upon considering all QSVP 

operational expenses, the LS Program 

determined that the actual cost of QSVP 

services, excluding travel costs, to be 

$108 per hour. LS Program management 

considered employee salaries and 

benefits; Agency and LS Program 

overhead; total revenue hours available 

to the ARC Branch; and included other 

anticipated costs such as, federally 

mandated pay raises through FY 2005, 

rent, communications, utilities, 

contractual services, supplies, and 

equipment in their analysis. 

The LS Program considered 

alternatives to creating a separate userfee for QSVP services, but found that 

none were sufficient. Maintaining the 

same user-fee for QSVP services 

currently used for conventional meat 

grading and certification services would 

not sufficiently cover the cost of 

providing QSVP services. Another 

option was to terminate all QSVP 

services, which would adversely affect 

producers, businesses, and consumers 

who desire QSVP services and those 

entities with already-established 

programs. 

The QSVP were administered through 

the LS Program’s MGC Branch pursuant 

to 7 CFR part 54 using the user-fee 

schedule established for meat grading 

and certification services. In 2001, the 

administration of QSVP was moved by 

the LS Program to the Audit, Review, 

and Compliance (ARC) Branch. This 

rule establishes a separate user-fee of 

$108 per hour for QSVP services under 

a new part 62. Additionally, this rule 

expands the scope of QSVP services to 

include all agricultural products or 

services within the responsibility of the 

LS Program, such as livestock, meat, 

meat products, seed, feedstuffs, as well 

as processes involving the production of 

these products, agricultural product 

data storage, product traceability and 

identification. A new part 62 is 

established for QSVP services. 

Executive Order 12866 

This rule has been determined to be 

not significant for purposes of Executive 

Order 12866 and, therefore, has not 

been reviewed by the Office of 

Management and Budget (OMB). 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. It is not intended to have 

retroactive effect and would not 

preempt or supersede any State or local 

laws, regulations, or policies, unless 

they present an irreconcilable conflict. 

There are no administrative procedures 

that must be exhausted prior to any 

judicial challenge to the provisions of 

this rule. 

58970 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations 

Regulatory Flexibility Act and 

Paperwork Reduction Act 

Pursuant to the requirements set forth 

in the Regulatory Flexibility Act 

(RFA)(5 U.S.C. 601 et seq.), AMS has 

considered the economic effect of this 

action on small entities and has 

determined that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

The purpose of RFA is to fit regulatory 

actions to the scale of businesses subject 

to such actions in order that small 

businesses will not be unduly burdened. 

AMS, through the LS Program’s ARC 

Branch, provides voluntary assessment 

services to approximately 415 

businesses, including 152 livestock 

slaughterers, 72 meat processors, 46 

livestock producers feeders, 135 organic 

certifying companies, 4 trade 

associations, and 4 State and Federal 

entities. Seventy-five percent (i.e., 346) 

of these businesses are classified as 

small entities and generate 

approximately 65 percent of the ARC 

Branch’s revenue. AMS anticipates that 

many new applicants for QSVP will be 

classified as small entities. The Small 

Business Administration (13 CFR 

121.201) defines small agricultural 

producers as those having annual 

receipts of less than $750,000; small 

agricultural service firms as those whose 

annual receipts are less than $6 million; 

and small meat packers as those that 

have less than 500 employees. No 

entity, small or large, is obligated to use 

voluntary QSVP services provided 

under the authority of AMA. 

AMS regularly reviews its user-feefinanced programs to determine if the 

fees are adequate to cover the cost of the 

services provided. The most recent 

review determined that the hourly rate 

previously charged by the ARC Branch 

for QSVP services did not generate 

sufficient revenues to recover operating 

costs for current and near-term periods 

while maintaining a 4-month operating 

reserve of $275,000. In FY 2004, the 

ARC Branch incurred a $330,000 

operating loss. Losses have depleted the 

ARC Branch’s operating reserve and 

placed the ARC Branch in an unstable 

financial position that could adversely 

affected its ability to provide QSVP 

services. 

While existing automated information 

management systems for data collection, 

retrieval, dissemination, applicant 

billing, and disbursement of employee 

entitlements, were utilized, the ARC 

Branch continued to lose revenue due to 

the cost of providing QSVP services 

utilizing auditors classified at the GS–

11/12 pay grade while charging a userfee that is based on a lower GS–5/7/9 

pay grade classification. 

The ARC Branch operating costs 

increased as a result of higher salaries 

associated with higher grade employees; 

congressionally mandated salary 

increases for all Federal Government 

employees; ongoing information system 

technology upgrades necessary to 

remain compatible with customer and 

Agency systems; inflation of non-salary 

operating expenses; and office 

maintenance expenses. AMS estimates 

that this action will provide the ARC 

Branch with an additional $576,000 for 

FY 2006, offsetting the FY 2005 

operating losses of $558,000. This fee 

increase will help create a 4-month 

operating reserve as required by AMS. 

The new part 62 includes sections on 

definitions; sections related to providing 

services, including availability and how 

to apply for services; and suspension, 

denial, or cancellation of service and 

other sections relating to fees. These 

sections are similar to, or the same as, 

provisions that currently apply to 

Quality Systems Verification Programs. 

The information collection 

requirements that appear in this final 

rule have been approved by OMB and 

assigned OMB Control Number 0581–

0124. Under this rule, applicants are 

required to submit a cover letter and a 

complete copy of the applicant’s 

program documentation when a request 

for service is made. This is a one-time 

requirement per service request. The 

QSVP also requires applicants to retain 

records and documents necessary to 

support the requested service for the 

period of at least one calendar year 

following the year the record was 

created and long enough to assess 

conformance of the product though the 

applicant’s quality management system. 

Additionally, applicants must ensure 

that such records and documents are 

readily available and easily accessible. 

AMS’ estimate for recordkeeping 

burden reflects the amount of time 

needed to prepare, store, and maintain 

documents. Based on its experience 

with QSVP, AMS understands that 

applicants develop and maintain 

complete documentation of their 

programs as a normal business practice. 

AMS believes the cost burden 

associated with submission of complete 

program documentation to be limited to 

the time needed for the applicant to 

review the documentation for 

completeness and accuracy. AMS 

estimates this time to average 24 hours 

per applicant at $20.00 per hour for a 

total one-time burden per applicant of 

$480.00. AMS estimates the total onetime burden if 50 applicants applied 

under this rule to be $24,000. 

Based on its experience, AMS also 

believes that the documents and records 

required to be retained are normally 

retained by applicants as part of their 

normal business practices. However, if 

record keepers were compensated for 

their time, AMS estimates that the time 

required for each applicant to retain 

these records and documents in a 

manner required in the rule to average 

6 hours per year at $20.00 per hour for 

a total annual burden of $120.00 per 

applicant. Assuming that 50 applicants 

are retained under this rule, the total 

annual burden is estimated to be $6,000. 

Comments concerning small business 

consideration and the information 

collection burden or discussed in the 

next section of this document. 

Comments 

AMS published a proposed rule in the 

April 7, 2005, Federal Register [66 FR 

17611] for public comment. The 

comment period ended on May 9, 2005. 

The comment period regarding the 

information collection requirements that 

would result from this proposal ended 

on June 6, 2005. The comments have 

been posted on AMS’ Web site at 

http://www.ams.usda.gov/lsg/arc/ 

rule.htm. 

Discussion of Comments 

USDA received 3 comments from 

interested persons, which included two 

seed trade organizations and one 

interested party. While one of the seed 

organizations did not oppose the 

proposed rule, the second 

recommended an alternative program 

that would delegate certification 

activities to existing organizations. The 

comment from the interested party 

opposed the QSVP as a new program 

that would enhance the federal deficit. 

The commenters raised a number of 

concerns including establishing 

duplicative or conflicting service for the 

seed industry and questioning the fee 

analysis itself. 

The QSVP is an established program 

that began providing service in 1995, as 

a voluntary, user-fee funded program, 

under the authority of the Agricultural 

Marketing Act of 1946. As such, 

expanding the scope of the QSVP to 

include all agricultural products and 

services within the responsibility of the 

LS Program will not enhance the federal 

deficit. Further, with regard to 

expanding program service to the seed 

industry, the QSVP will facilitate the 

global marketing and trade of not only 

seeds and seed products, but all 

agricultural products and services under 

the LS Program. With regard to the 

concerns raised about duplicative and 

conflicting service for the seed industry, 

Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations 58971 

we believe that the QSVP has and will 

provide a valuable resource for those 

businesses and industries that wish to 

use a USDA shield or statement. One 

commenter noted that some facilities are 

already ISO certified and that this 

should be taken into account in the 

QSVP procedure. To the extent 

appropriate, ISO certification will be 

taken into account under QSVP. 

One commenter suggested that the 

QSVP programs be changed to a 

program that would delegate 

certification activities to existing 

organizations. Also, another commenter 

was concerned about the QSVP adding 

a layer of complexity in connection with 

marketing of seed both domestically and 

internationally. The existing QSVP 

provides services to primarily the 

livestock and meat industries. This final 

rule will provide the same services in 

the expanded program format, which 

includes the seed industry. As such, this 

does not represent a significant program 

change. Further, individual entities are 

free to request QSVP services or not, as 

the program is voluntary. 

Concerns were raised about certain 

aspects of the fee analysis. Two 

commenters were of the view that the 

$20.00 per hour used to estimate the 

costs for the applicant was too low. As 

part of the Paperwork Reduction Act 

burden estimate, a $20.00 per hour cost 

was based upon our experience with 

QSVP and is reasonable for purposes of 

information collection burden estimates. 

The $20.00 cost is separate and distinct 

from the $108.00 per hour fee. The 

commenters also noted that the 

methodology concerning the $108.00 

per hour fee is sound, but that nonsalary expenses were three times the 

expense for salaries. The charge of 

$108.00 per hour reflects the rate 

necessary to recover the costs of 

administering the QSVP. AMS 

considered numerous factors in 

developing the rate to charge to provide 

services. AMS and LS Program 

management considered employee 

salaries and benefits; Agency and LS 

Program overhead; total revenue hours 

available to the ARC Branch; and 

included other anticipated costs, such 

as federally mandated pay raises, rent, 

communications, utilities, contractual 

services, supplies, and equipment in 

their analysis. 

Finally, one commenter questioned 

the salaries of the employees used in the 

program. This commenter also disagreed 

that the rule will not have a significant 

economic impact on small companies. 

AMS estimates that this action will 

provide an additional $420,000 for FY 

2005. Of the $420,000, small businesses 

would pay an average of $878.00 more 

per year per applicant. A similar result 

is expected for new applicants who 

would be considered small businesses. 

Further, no entity, small or large, is 

obligated to use voluntary QSVP 

services provided under the authority of 

the AMA. Accordingly, we disagree 

with this comment. 

Another commenter questioned the 

size of businesses with 5,000 

employees, noting that such entities 

should be considered large businesses. 

Under Small Business Administration 

criteria, certain entities with less than 

500 employees are considered small 

businesses. 

No changes to the regulation will be 

made as a result of the comments 

received. However, AMS will continue 

to work with the existing trade 

organizations and their respective 

industries regarding implementation of 

this and any future rulemakings. 

Pursuant to 5 U.S.C. 533, it is found 

and determined that good cause exists 

for not postponing the effective date of 

this action until 30 days after 

publication in the Federal Register. The 

fees should be implemented as soon as 

possible to avoid further financial losses 

for the program. Given the current status 

of this program, our effective date of two 

weeks after publication in the Federal 

Register is reasonable. 

List of Subjects 

7 CFR Part 54 

Meats, Prepared Meats, and Meat 

Products. 

7 CFR Part 62 

Food grades and standards, Food 

labeling, Meat and meat products. 

■ For the reasons set forth in the 

preamble, chapter 1 of title 7 of the 

Code of Federal Regulations is amended 

by amending part 54 and adding part 62 

to read as follows: 

PART 54—[AMENDED] 

■ 1. The authority citation for part 54 

continues to read as follows: 

Authority: 7 U.S.C. 1621–1627. 

§ 54.4 [Amended] 

■ 2. In § 54.4, paragraph (5) is removed. 

■ 3. Part 62 is added to read as follows: 

PART 62—LIVESTOCK, MEAT, AND 

OTHER AGRICULTURAL 

COMMODITIES (QUALITY SYSTEMS 

VERIFICATION PROGRAMS) 

Subpart A—Quality Systems Verification 

Programs Definitions 

Sec. 

62.000 Meaning of terms. 

Administration 

62.100 Administrator. 

Service 

62.200 Services. 

62.201 Availability of service. 

62.202 How to apply for service. 

62.203 How to withdraw service. 

62.204 Authority to request service. 

62.205 Conflict of interest. 

62.206 Access to program documents and 

activities. 

62.207 Official assessment. 

62.208 Publication of QSVP assessment 

status. 

62.209 Reassessment. 

62.210 Denial, suspension, or cancellation 

of service. 

62.211 Appeals. 

62.212 Official assessment reports. 

62.213 Official identification. 

Charges for Service 

62.300 Fees and other costs for service. 

62.301 Payment of fees and other charges. 

Miscellaneous 

OMB Control Number 

62.400 OMB control number assigned 

pursuant to the Paperwork Reduction 

Act. 

Authority: 7 U.S.C. Sec. 1621–1627. 

Subpart A—Quality Systems 

Verification Programs Definitions 

§ 62.000 Meaning of terms. 

Words used in this subpart in the 

singular form shall be deemed to impart 

the plural, and vice versa, as the case 

may demand. For the purposes of such 

regulations, unless the context 

otherwise requires, the following terms 

shall be construed, respectively, to 

mean: 

Administrator. The Administrator of 

the Agricultural Marketing Service 

(AMS), or any officer or employee of 

AMS to whom authority has heretofore 

been delegated or to whom authority 

may hereafter be delegated, to act in the 

Administrator’s stead. 

Agricultural Marketing Service. The 

Agricultural Marketing Service of the 

U.S. Department of Agriculture. 

Applicant. Any individual or business 

with financial interest in QSVP services 

who has applied for service under this 

part. 

Assessment. A systematic review of 

the adequacy of program or system 

documentation, or the review of the 

completeness of implementation of a 

documented program or system. 

Auditor. Person authorized by the 

Livestock and Seed Program to conduct 

official assessments. 

Branch. The Audit, Review, and 

Compliance Branch of the Livestock and 

Seed Program. 

Chief. The Chief of the ARC Branch, 

or any officer or employee of the Branch 

58972 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations 

to whom authority has heretofore been 

delegated, or to whom authority may 

hereafter be delegated, to act in the 

Chief’s stead. 

Conformance. A user’s quality manual 

and supporting documentation. 

Deputy Administrator. The Deputy 

Administrator of the Livestock and Seed 

Program, or any officer or employee of 

the Livestock and Seed Program to 

whom authority has heretofore been 

delegated, or to whom authority may 

hereafter be delegated, to act in the 

Deputy Administrator’s stead. 

Financially interested person. Any 

individual, partnership, corporation, 

other legal entity, or Government agency 

having a financial interest in the 

involved product or service. 

Livestock. Bovine, ovine, porcine, 

caprine, bison or class of Osteichthyes. 

Official mark. Official mark or other 

official identification means any form of 

mark or other identification, used under 

the regulations to show the conformance 

of products with applicable program 

requirements, or to maintain the 

identity of products for which service is 

provided under the regulations. 

Official memoranda or assessment 

reports. Official memorandum means 

any assessment report of initial or final 

record of findings made by an 

authorized person of services performed 

pursuant to the regulations. 

Products. Includes all agricultural 

commodities and services within the 

scope of the Livestock and Seed 

Program This includes livestock, meat, 

meat products, seed, feedstuffs, as well 

as processes involving the production of 

these products, agricultural product 

data storage, product traceability and 

identification. 

QSVP Procedures. Audit rules and 

guidelines set forth by the Agricultural 

Marketing Service regarding the 

development, documentation, and 

implementation of QSVP. 

Quality Manual. A collection of 

documents that describe the applicant’s 

quality management system, as it 

applies to the requested service. 

Quality Systems Verification 

Programs (QSVP). A collection of 

voluntary, audit-based, user-fee 

programs that allow applicants to have 

program documentation and program 

processes assessed by AMS auditor(s) 

and other USDA officials under this 

part. 

Regulations. The regulations in this 

part. 

USDA. The U.S. Department of 

Agriculture. 

Administration 

§ 62.100 Administrator. 

The LS Program Deputy 

Administrator is charged with the 

administration of official assessments 

conducted according to the regulations 

in this part and approved LS Program 

QSVP procedures. 

Service 

§ 62.200 Services. 

QSVP, under this regulation, provide 

applicants, the ability to have USDA 

assess documented processes or 

systems. 

(a) Assessment services provided 

under the regulations shall consist of: 

(1) A review of the adequacy of an 

applicant’s quality manual against LS 

Program QSVP procedures, 

internationally recognized guidelines, or 

other requirements as approved by the 

LS Program; 

(2) An onsite assessment of the 

applicant’s program to ensure 

implementation of provisions within the 

quality manual and the applicant’s 

conformance with applicable program 

requirements and LS Program QSVP 

procedures; and 

(3) A reassessment of the applicant’s 

program to ensure continued 

implementation of provisions within the 

quality manual and the applicant’s 

conformance with program 

requirements and applicable LS 

Program QSVP procedures; 

(b) Developmental assistance in the 

form of training to explain LS Program 

QSVP procedures is available upon 

request. 

§ 62.201 Availability of service. 

QSVP services under these 

regulations are available to international 

and domestic government agencies, 

private agricultural businesses and any 

finically interested person. 

§ 62.202 How to apply for service. 

Applicants may apply for QSVP 

services by submitting the following 

information to the ARC Branch 

headquarters office at USDA, AMS, LSP, 

ARC Branch, 1400 Independence 

Avenue, SW., STOP 0294, Room 2627- 

S, Washington, DC 20250–0294; by fax 

to: (202) 690–1038, or e-mail to: 

ARCBranch@usda.gov. 

(a) The original completed form LS–

313, Application for Service; 

(b) A letter requesting QSVP services; 

and 

(c) A complete copy of the applicant’s 

program documentation, as described in 

the LS Program QSVP procedures. 

§ 62.203 How to withdraw service. 

Service may be withdrawn by the 

applicant at any time; provided that, the 

applicant notifies the ARC Branch in 

writing of his/her desire to withdraw 

the application for service and pays any 

expenses the Department has incurred 

in connection with such application. 

§ 62.204 Authority to request service. 

Any person requesting service may be 

required to prove his/her financial 

interest in the product or service at the 

discretion of the Deputy Administrator. 

§ 62.205 Conflict of interest. 

No USDA official shall review any 

program documentation or determine 

conformance of any documented 

process or system in which the USDA 

official has financial holdings. 

§ 62.206 Access to program documents 

and activities. 

(a) The applicant shall make its 

products and program documentation 

available and easily accessible for 

assessment, with respect to the 

requested service. Auditors and other 

USDA officials responsible for 

maintaining uniformity and accuracy of 

service under the regulations shall have 

access to all parts of facilities covered 

by approved applications for service 

under the regulations, during normal 

business hours or during periods of 

production, for the purpose of 

evaluating products or processes. This 

includes products in facilities which 

have been or are to be examined for 

program conformance or which bear any 

official marks of conformance. This 

further includes any facilities or 

operation that is part of an approved 

program. 

(b) Documentation and records 

relating to an applicant’s program must 

be retained for at least one calendar year 

following the calendar year during 

which the record was created. 

§ 62.207 Official assessment. 

Official assessment of an applicant’s 

program shall include: 

(a) Documentation assessment. 

Auditors and other USDA officials shall 

review the applicant’s program 

documentation and issue finding of the 

review to the applicant. 

(b) Program assessment. Auditors and 

USDA officials shall conduct an onsite 

assessment of the applicant’s program to 

ensure provisions of the applicant’s 

program documentation have been 

implemented and conform to LS 

Program QSVP procedures. 

(c) Program Determination. 

Applicant’s determined to meet or not 

meet LS Program QSVP procedures or 

Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations 58973 

the applicant’s program requirements 

shall be notified of their program’s 

approval or disapproval. 

(d) Corrective and/or preventative 

actions. Applicants may be required to 

implement corrective and/or 

preventative actions upon completion of 

assessment. After implementation of 

corrective and/or preventative actions, 

the applicant may request another 

assessment. 

§ 62.208 Publication of QSVP assessment 

status. 

Approved programs shall be posted 

for public reference on the ARC Branch 

Web site: http://www.ams.usda.gov/lsg/ 

arc/audit.htm. Such postings shall 

include: 

(a) Program name and contact 

information, 

(b) Products or services covered under 

the scope of approval, 

(c) Effective dates of approval, and 

(d) Control numbers of official 

assessments, as appropriate, and 

(e) Any other information deemed 

necessary by the Branch Chief. 

§ 62.209 Reassessment. 

Approved programs are subject to 

periodic reassessments to ensure 

ongoing conformance with the LS 

Program QSVP procedures covered 

under the scope of approval. The 

frequency of reassessments shall be 

based on the LS Program QSVP 

procedures, or as determined by the 

Deputy Administrator. 

§ 62.210 Denial, suspension, or 

cancellation of service. 

(a) QSVP services may be denied if an 

applicant fails to meet its program 

requirements, or conform to LS Program 

QSVP procedures, such as: 

(1) Adequately address any program 

requirement resulting in a major nonconformance or an accumulation of 

minor non-conformances that result in 

the assignment of a major nonconformance for the program. 

(2) Demonstrate capability to meet 

any program requirement resulting in a 

major non-conformance. 

(3) Present truthful and accurate 

information to any auditor or other 

USDA official; or 

(4) Allow access to facilities and 

records within the scope of the program. 

(b) QSVP services may be suspended 

if the applicant fails to meet its program 

requirements, or conform to LS Program 

QSVP procedures; such as failure to: 

(1) Adequately address any program 

requirement resulting in a major nonconformance; 

(2) Demonstrate capability to meet 

any program requirement resulting in a 

major non-conformance; 

(3) Follow and maintain it’s approved 

program or QSVP procedures; 

(4) Provide corrective actions and 

correction as applicable in the 

timeframe specified; 

(5) Submit significant changes to and 

seek approval from the Chief prior to 

implementation of significant changes 

to an approved program; 

(6) Allow access to facilities and 

records within the scope of the 

approved program; 

(7) Accurately represent the eligibility 

of agricultural products or services 

distributed under an approved program; 

(8) Remit payment for QSVP services; 

(9) Abstain from any fraudulent or 

deceptive practice in connection with 

any application or request for service 

under the rule; or 

(10) Allow any auditor or other USDA 

official to perform their duties under the 

regulations of this part. 

(c) QSVP services maybe be cancelled, 

an application may be rejected, or 

program assessment may be terminated 

if the Deputy Administrator or his 

designee determines that a 

nonconformance has remained 

uncorrected beyond a reasonable 

amount of time. 

§ 62.211 Appeals. 

Appeals of adverse decisions under 

this part, may be made in writing to the 

Livestock and Seed Program Deputy 

Administrator at STOP 0249, Room 

2092-South, 1400 Independence 

Avenue, SW., Washington, D.C. 20250–

0249. Appeals must be made within 30 

days of receipt of adverse decision. 

(a) Procedure for Appeals. Actions 

under this subparagraph concerning 

decision of appeals of the Deputy 

Administrator shall be conducted in 

accordance with the Rule of Practice 

Governing Formal Adjudicatory 

Proceedings Instituted by the Secretary 

Under Various Statutes set forth at 7 

CFR § 1.130 through § 1.151 and the 

Supplemental Rules of Practice in 7 CFR 

part 50. 

(b) [Reserved] 

§ 62.212 Official assessment reports. 

Official QSVP assessment reports 

shall be generated by the auditor at the 

conclusion of each assessment and a 

copy shall be provided to the applicant. 

§ 62.213 Official identification. 

The following, as shown in figure 1, 

constitutes official identification to 

show product or services produced 

under an approved USDA, Process 

Verified Program (PVP): 

Figure 1. 

(a) Products or services produced 

under an approved USDA, PVP may use 

the ‘‘USDA Process Verified’’ statement 

and the ‘‘USDA Process Verified’’

shield, so long as, both the statement 

and shield are used in direct association 

with a clear description of the process 

verified points that have been approved 

by the Branch. 

(b) Use of the ‘‘USDA Process 

Verified’’ statement and the ‘‘USDA 

Process Verified’’ shield shall be 

approved in writing by Chief prior to 

use by an applicant. 

Charges for Service 

§ 62.300 Fees and other costs for service. 

Fees and other charges will be levied 

based on the following provisions: 

(a) Fees for service. Fees for QSVP 

services shall be based on the time 

required to provide service calculated to 

the nearest quarter hour period, 

including, but not limited to, official 

assessment time, travel time, and time 

required to prepare assessment reports. 

The hourly fee rate shall be $108 per 

hour. 

(b) Transportation costs. Applicants 

are responsible for paying actual travel 

costs incurred to provide QSVP services 

including but not limited to: Mileage 

charges for use of privately owned 

vehicles, rental vehicles and gas, 

parking, tolls, and public transportation 

costs such as airfare, train, and taxi 

service. 

(c) Per diem costs. The applicant is 

responsible for paying per diem costs 

incurred to provide QSVP services away 

from the auditor’s or USDA officials’

official duty station(s). Per diem costs 

shall be calculated in accordance with 

existing travel regulations (41 CFR, 

subtitle F—Federal Travel Regulation 

System, chapter 301). 

(d) Other costs. When costs, other 

than those costs specified in paragraphs 

(a), (b), and (c) of this section, are 

involved in providing the QSVP 

services, the applicant shall be 

responsible for these costs. The amount 

of these costs shall be determined 

administratively by the Chief. However, 

the applicant will be notified of these 

costs before the service is rendered. 


ER11OC05.174</GPH>
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