This rule has been determined to be economically significant under Executive Order 12866, and major under Pub. L. 104-121, and has, therefore, been reviewed by the Office of Management and Budget (OMB).

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. FNS has considered the impact on State agencies. This rule deals almost entirely with changes required by law, and implemented by law in 1996. The changes primarily affect food stamp recipients. The effects on State agencies are minimal and, to the extent that they affect them, relieve them of administrative burdens. This rule is intended to have preemptive effect on any State law that conflicts with its provisions or that would otherwise impede its full implementation. PRWORA required all but one of the changes made in this rule, and made most of them effective on enactment and all of them effective by the beginning of FY 1997. FNS is not aware of any case where the one discretionary provision of the rule would preempt State law.

Before drafting this rule, we received input from State agencies at various times. Because the FSP is a State administered, federally funded program, our regional offices have formal and informal discussions with State and local officials on an ongoing basis. These discussions involve implementation and policy issues. This arrangement allows State agencies to provide feedback that forms the basis for many discretionary decisions in this and other FSP rules. In addition, FNS officials attend regional, national, and professional conferences to discuss issues and receive feedback from State officials at all levels. Lastly, the comments on the proposed rule from State officials were carefully considered in drafting this final rule.

This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612). Shirley R. Watkins, Under Secretary for Food, Nutrition, and Consumer Services, has certified that this rule will not have a significant economic impact on a substantial number of small entities. State and local welfare agencies will be the most affected to the extent that they administer the Program. Participants will be affected to the extent that their benefits will not increase at the rate they would have under the old law.

This proposed rule does not contain reporting or record keeping requirements subject to approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies that conflict with its provisions or that would otherwise impede its full implementation. This final rule is not intended to have retroactive effect unless so specified in the “Dates” paragraph of this rule. Prior to any judicial challenge to the provisions of this rule or the application of its provisions, all applicable administrative procedures must be exhausted. In the Food Stamp Program the administrative procedures are as follows: (1) For Program benefit recipients—State administrative procedures issued pursuant to 7 U.S.C. 2020(e)(1) and 7 CFR 273.15; (2) for State agencies—administrative procedures issued pursuant to 7 U.S.C. 2023 set out at 7 CFR 276.7 (for rules related to non-quality control (QC) liabilities) or Part 283 (for rules related to QC liabilities); (3) for retailers and wholesalers—administrative procedures issued under 7 U.S.C. 2023 set out at 7 CFR 278.8 and Part 279.

Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal Mandates” that may result in expenditures to State, local, or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year.

When such a statement is needed for a rule, section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule.

This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) that impose costs on State, local, or tribal governments or to the private sector of $100 million or more in any one year. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This action is needed to implement several provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, Pub. L. 104-193. This rule removes the exception in current rules that allows persons age 21 and under who are themselves parents or married, and who live with a parent, to participate in the Food Stamp Program as a separate household; changes the way the maximum allotments are calculated by using 100% of the Thrifty Food Plan instead of 103%; alters the definition of homeless by setting a time limit (where there was none before) on people whose primary nighttime residence is a temporary accommodation in the home of another; freezes the standard deduction in food stamps for fiscal year 1997 and beyond at $134; retains a cap on the excess shelter expense deduction; freezes the fair market value of vehicle exemption at $4,650; freezes the minimum allotment at $10 a month; increases the number of days which States have to provide expedited service from 5 to 7 calendar days; eliminates households consisting entirely of homeless people from those categories of households entitled to receive expedited service; and removes the State agency option to exclude from unearned income up to $50 monthly of title IV-D child support payments.

State food stamp offices are affected to the extent that they must implement the provisions described in this action. However, State agencies are not expected to change their personnel due to these changes, so State agencies are expected to incur minimal costs.

The final rule does not make any economically significant changes to the proposed rule. However, food stamp participation has decreased more than expected since we published the proposed rule. Current estimates of participation are about 20 percent less than previous estimates. Accordingly, total savings in food stamps issued from this rule for the 5 years from fiscal year 1998 to 2002 are $9,039 million—down from the previous estimate of $11,195 million.

We have written this final rule under the plain language guidelines to make it easier to read and clearer. We have edited wording that we preserved from the proposed rule to conform to those guidelines, using simpler words and phrases where appropriate, and changing sentences from passive to active voice. We did not change the meaning of any of the language brought from the proposed rule.

The President signed the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, Pub. L. 104-193 (PRWORA) on August 22, 1996. PRWORA contained several provisions that amended the Food Stamp Act of 1977 (the Act), 7 U.S.C. 2011, et seq. , but allowed us (the Food and Nutrition Service of the Department of Agriculture) no discretion in implementing them. We published proposed rules on July 12, 1999, in the Federal Register at 64 FR 37454 to implement those provisions. The provisions:

• Require that a person 21 years old or younger who lives with a parent be considered part of the parent's household, even if married and living with a spouse, living with a child, or both;

• Set the maximum allotment at 100% of the Thrifty Food Plan, rather than at 103%;

• Allow a person living in another person's house to be considered homeless for only 90 days;

• Freeze the standard deduction at $134;

• Retain the cap on the excess shelter expense deduction;

• Freeze the exemption of the fair market value of a vehicle as a household asset at $4,650;

• Freeze the minimum allotment for 1- and 2-person households at $10;

• Increase from 5 to 7 the number of days State agencies have to provide expedited service;

• Eliminate households consisting entirely of homeless persons from the kinds of households automatically allowed to receive expedited service; and

• Remove the State agency option to exclude up to $50 a month of the title IV-D child support payments from unearned income.

The period for comment on the proposed rules ended September 10, 1999. We received comments on the proposed rules from ten State agencies and an advocacy group. (In addition, the Acting General Counsel of a State agency commented on our failure to treat a number of discretionary provisions of PRWORA in this rulemaking. Those provisions will be covered in other rules that are currently in clearance or which have recently been published. We will not deal with them here.) In analyzing the comments received, we will not address comments on provisions that are required by the law and on which we have no discretion. A number of comments supported our proposals. We will not discuss those in detail here, either. Finally, a number of the comments concerned technical corrections for inadvertent omissions. We have made the corrections where appropriate, but will not discuss the comments. For a full understanding of the background of the provisions in this rule see the proposed rulemaking. In response to those comments that need discussion, and for ease of reading, we will discuss each provision touched on by those comments, and the comments, in the order in which they appear in the Code of Federal Regulations.

Definition of Parental Control: Although not contemplated by PRWORA, to provide the same treatment for a child living with a non-parent adult that is provided for a child living with a natural or adoptive parent or stepparent, we proposed to change the definition of parental control, amending 7 CFR 273.1 by removing the exception that a child who is living with his or her own child(ren) or spouse is not considered to be under parental control. A State agency commented that under its State law a married person under 18 has attained majority and no other person is responsible for that person. We have amended the language of the final rule to accommodate such a situation. Another State agency noted our removal of the exception, and stated its understanding that it could choose to retain the old policy if it applied it consistently across the State. This is incorrect. Our view is that a child who is under parental control must be a member of the household that exercises parental control, even if the child has children of his or her own. However, State agencies will have substantial authority to determine parental control.

Reorganization of 7 CFR 273.1—Household Concept: In the spirit of the President's Regulatory Reform Initiative, we proposed to reorganize § 273.1 (which deals with the important programmatic concept of “household”), with the exception of 7 CFR 273.1(d) and (f), which we left unchanged. We did not propose significant changes to § 273.1, as nearly every provision is set forth in the Act and can be changed only through legislative action. However, we condensed several sections into a single section, removing unnecessary language and provisions covered elsewhere in the regulations, and providing State agency flexibility where possible. The proposed rule set out the entire suggested revised text for the convenience of the reader.

Boarders: To ensure uniformity among all States, we proposed to retain in new paragraph (b)(3) the language appearing in 7 CFR 273.1(c)(1), which defines a boarder. Whether a person is considered to be a boarder, and whether, if deemed a boarder, a person may participate in the Food Stamp Program, is in part determined by whether the person pays reasonable compensation for lodging and meals. A State agency, in its comments, asked why not, in the interest of State flexibility, allow States to define what constitutes “reasonable” compensation. However, the State agency did not give any further reason to change the existing regulation, and another State agency noted that it had no objection to the purely cosmetic change to the provision. This provision as written is easy to administer, equitable to clients, and adaptable to each State's automated certification system. Moreover, it has not been a problem for State agencies or clients in the past. For these reasons, and because the Thrifty Food Plan base is a practicable way to determine whether a person is paying reasonable compensation in order to decide boarder status, and was previously subject to public comments, we do not think the definition should be changed based on a single comment in this rule.

An advocate organization commented that we should make it clear that the definition of a commercial boarding house does not include group homes for disabled, homeless shelters, or other such entities that may be licensed under the same State laws as commercial boarding houses. Group homes for disabled (group living arrangements), for example, are defined in 7 CFR 271.2 as public or private nonprofit entities, and proposed 7 CFR 273.1(b)(7)(vii)(E) specified public or private nonprofit homeless shelters. We have modified the language of the rule to make it clear that the entities excepted from the rule barring residents of institutions must not be confused with commercial boarding houses.

When we combined 7 CFR 273.1(a)(2), (b), (c)(1), (c)(3), and (e) in new paragraph (b), we eliminated 7 CFR 273.1(c) of current regulations. We added a new paragraph (c). There has been some confusion among State agencies as to when the policy on “purchasing food and preparing meals” overrides policy prohibiting the separation of spouses and children, or prohibiting the participation of boarders. The new paragraph (c) specifically allows State agencies to apply discretion when the rule does not lend itself to a simple and direct answer to certain living situations. We cannot cover all living situations by regulation. We intend that State agencies use prudent judgment in determining when to allow individuals to be certified as separate households from others with whom they reside and to protect Program integrity by not allowing great numbers of households to fragment into smaller households. The language also states that any State policy adopted under this provision must be applied consistently throughout the State.

A State agency commented that the “Administrative Procedures Act” requires it to develop rules for any options allowed by Food Stamp Program regulations (we presume the State agency was referring to its own State Administrative Procedures Act, since States are not subject to the Federal Administrative Procedure Act, 5 U.S.C. 500, et seq. ). It added that if USDA cannot cover all living situations by regulations, a State agency cannot be expected to do so and ensure that they are handled consistently throughout the State. We recognize that it may be difficult for States to spell out clear policies in this area and ensure that they are applied across the State, but we are reluctant to impose such exacting rules that States cannot adapt the rules to local situations. We have, however, added the words “fairly” and “equitably” to the rule to ensure that a State agency's policy must be not only consistent, but also fair. Moreover, we stand ready to work with State agencies on a case-by-case basis to determine whether individual cases fit a pattern that should be applied across the State, or are unique cases.

Strikers. We did not propose any changes in 7 CFR 273.1(d), Head of Household, and (f), Authorized Representative, because we believe the current regulations are appropriate. We have redesignated the requirements in current regulations at 7 CFR 273.1(g) for determining the eligibility and benefits of households containing members on strike as paragraph (e), with minor editorial changes for clarity. We received no comments on our decisions with regard to these provisions.

Expedited Service: Current regulations at 7 CFR 273.2(i) provide for expedited service to certain categories of households with very low income and resources, including households in which all members are homeless. Prior to PRWORA, section 11(e)(9) of the Act (7 U.S.C. 2020(e)(9)) required that benefits be provided not later than five calendar days following a household's date of application for all eligible households that were also eligible for expedited service. Section 838 of PRWORA amended section 11(e)(9) of the Act by increasing the time that States may take to provide expedited service from five to seven calendar days, and eliminating households consisting entirely of homeless people from those categories of households entitled to receive expedited service. We received no comments on the proposal to implement these changes, as outlined in the proposed rule.

Accordingly, consistent with our proposals, this rule amends 7 CFR 273.2(i)(3)(i) by striking “fifth” calendar day and inserting “seventh”. This rule also amends 7 CFR 273.2(i)(3)(ii) by striking “5 calendar days” and inserting “7 calendar days”. In addition, the rule removes 7 CFR 273.2(i)(1)(iii) which provides that households in which all members are homeless individuals are entitled to expedited service and redesignates (i)(1)(iv) as (i)(1)(iii). Homeless individuals may continue to qualify for expedited service under the financial criteria set forth in 7 CFR 273.2(i).

Fair Market Value: Section 810 of PRWORA amended section 5(g) of the Act (7 U.S.C. 2014(g)) to provide that any licensed vehicle that is not subject to other exclusions and is used for household transportation or to obtain or continue employment, to the extent that the fair market value of the vehicle exceeds $4,600 through September 30, 1996, and $4,650 beginning October 1, 1996, must be included in financial resources. Section 810 also freezes the fair market value exclusion limit used in determining the countable value of the included vehicle at $4,650. Accordingly, this rule amends 7 CFR 273.8 to include the new resource exclusion level, which was implemented October 1, 1996.

We proposed to modify the definition of a vehicle that can be excluded from a household's assets because it is used for income-producing purposes in the current rules at 7 CFR 273.8(h)(1)(i) (redesignated 273.8(e)(3)(i)(A)). Examples of such vehicles would be a car used for a job as a delivery person, a motor vehicle used by a courier, a car used by a household member to call on clients or customers, even though the vehicle is not used for long-distance travel, or any vehicle used to perform a job that was advertised as requiring a personally-owned motor vehicle. The current rule requires that the vehicle be used primarily for producing income. We proposed to remove the word “primarily” to ensure that State agencies would not have to verify the relative amount of mileage traveled for income-producing purposes. Two State agencies commented that our proposal did not go far enough. They proposed that we exclude any vehicle used to go to work. Section 5(g)(1)(C) of the Act does not allow us to change the rules to that extent. Specifically, it excludes from a household's financial resources a vehicle “used to produce earned income.” This language allows us to make the change we proposed, since a vehicle used for deliveries is clearly being used to produce earned income. We do not believe that a reasonable view of the clear language of the Act allows us to exclude all vehicles used to commute to work. Accordingly, this rule amends 7 CFR 273.8 to remove the requirement that a vehicle used for income-producing purposes be used primarily for those purposes in order to be excluded from a household's assets.

A State agency commented that the language on vehicles necessary to transport a physically disabled household member at § 273.8(e)(3)(i)(E) seems somewhat contradictory because it talks about special vehicles and specially equipped vehicles being considered necessary, but then goes on to state that the vehicle need not have special equipment. We agree. We have removed the examples and have simplified the provision, relying on the basic statement that a vehicle necessary to transport a physically disabled household member is excluded.

In the proposed rule, we took the opportunity to reorganize 7 CFR 273.8 and to remove redundant or unnecessary language. Section 5(g)(2) of the Act requires that the Secretary prescribe inclusions in, and exclusions from, financial resources following the regulations in force as of June 1, 1982. The law provides an exception for the regulations governing vehicles and inaccessible resources. All other resource inclusion and exclusion provisions described in the regulations as of June 1, 1982, became law by reference and can only be changed through legislative action. Nonetheless, there were some provisions we were able to change and some areas where we could remove redundant or unnecessary language. This rule revises 7 CFR 273.8(e), (g), (h), and (i), and removes (j).

We proposed to remove all the provisions from paragraph (h) and transfer some of them to (e) and the others to (g). We have taken the list of vehicles excluded from resource consideration currently contained in paragraphs (h)(1)(i)-(v) and (h)(2) and incorporated it into 7 CFR 273.8(e)(3). We rewrote the remaining provisions of paragraphs (h)(3), (h)(4) and (h)(5) concerning the treatment of non-excluded vehicles and combined them with the provisions in paragraph (g) to improve readability. As a result of transferring the text of paragraph (h), that paragraph no longer exists, and we have redesignated paragraph (i) as paragraph (h). We have made a conforming amendment to paragraphs (e)(16) and (e)(18) to note the relocation of the vehicle exclusion provisions. We also, in the proposed rule, removed the current 7 CFR 273.8(j), which provides that the resources of certain non-household members must be treated in accordance with 7 CFR 273.11. We believed the reference was unnecessary. After reviewing comments, and reconsidering the rule, we have decided to retain the reference as a useful guide to policy.

In keeping with the principles of the President's Regulatory Reform Initiative of increasing State flexibility, this rule removes the proscriptive regulations in paragraph (g) for determining the fair market value of a vehicle and allows State agencies to establish their own methodologies. However, to ensure client protection, we have decided to retain the prohibition against increasing the basic value of a vehicle because of low mileage, optional equipment, or special apparatus for the handicapped, as State variations may affect eligibility and costs.

We proposed also to revise paragraph (e)(11), which excludes from countable resources any resource that is specifically excluded by any other Federal statute and lists such excluded resources. We proposed to remove the specific list of resources excluded by other Federal laws. We periodically provide State agencies with a list of such excluded resources through agency memoranda because the list changes frequently and quickly becomes outdated. Doing this through the regulatory amendment process often results in incomplete or obsolete regulations, thereby causing confusion. We believe it is sufficient to have the regulation simply provide an exclusion for any resource specifically excluded by another Federal statute and to continue to notify State agencies through agency memoranda when such laws are enacted. We received no comments on this provision (other than one urging us to inform State agencies promptly in writing of all exclusions, which we currently do). Therefore, we are amending the rule accordingly.

Annual adjustments of gross and net income standards, and maximum allotments. FNS currently publishes Notices in the Federal Register every year to announce the amounts of the monthly gross and net income eligibility standards, and of the maximum allotments, for the contiguous 48 States and the District of Columbia, Alaska, Hawaii, Guam and the U.S. Virgin Islands. This process is cumbersome. The regulatory clearance process precludes publishing the numbers in time for State agencies to use them. Therefore, we send the numbers to the State agencies by memorandum—customarily in August, so the State agencies can program their computers in time for the new numbers to take effect on the October 1 deadline each year. We have started posting the new numbers on the FNS web site shortly after we officially notify State agencies of them. This accomplishes the same thing as publishing Notices in the Federal Register . And it does it on time, and more economically. Therefore, we will no longer publish these numbers in Federal Register Notices. You can find them on our web site at www.fns.usda.gov/fsp. We are making a technical change to delete references to publication of these numbers in Federal Register Notices from our rules.

Income exclusions: Current regulations at 7 CFR 273.9(c)(1)(i) prescribe whether to exclude from income a number of kinds of public assistance (PA) vendor payments (payments made by a third party on behalf of a household). A commenter pointed out that a number of State agencies are now using Temporary Assistance for Needy Families (TANF) funds to supplement housing assistance from the Department of Housing and Urban Development (HUD), and are channeling those payments through State or local housing authorities. Section 5(k)(2)(D) of the Act, 7 U.S.C. 2014(k)(2)(D), requires us to exclude such payments from income. The commenter inferred that we had overlooked this requirement of the Act in a previous revision of the rules. Since the Act requires us to exclude this new category of TANF-funded vendor payments from income, we are making a technical correction to the rules at 7 CFR 273.9(c)(1)(i) to make this requirement clear. (We received the comment after the end of the comment period, but we believe it is important to correct the rule in any case.)

Standard Deduction: Current regulations at 7 CFR 273.9(d)(8) provide that, effective October 1, 1987, and each October 1 thereafter, the standard deduction from gross income must be adjusted to reflect changes in the CPI-U for items other than food for the twelve months ending the preceding June 30. Section 809 of PRWORA amended section 5(e) of the Act to provide that the Secretary must allow and maintain the standard deduction for each household in the 48 contiguous States and the District of Columbia, Alaska, Hawaii, Guam, and the Virgin Islands of the United States of $134, $229, $189, $269, and $118, respectively. In effect, PRWORA eliminated the annual adjustment to the various standard deductions. This rule amends the regulations at 7 CFR 273.9(d)(1) accordingly.

Excess Shelter Expense Deduction: Section 809 of PRWORA amended section 5(e) of the Act to change the excess shelter limit. Section 5(e), 7 U.S.C. 2014(e), now provides that a household is entitled to an excess shelter expense deduction to the extent that the monthly amount expended by a household for shelter exceeds an amount equal to 50 percent of monthly household income after all other applicable deductions have been allowed. In the case of a household that does not contain an elderly or disabled individual, in the 48 contiguous States and the District of Columbia, Alaska, Hawaii, Guam and the Virgin Islands of the United States, the excess shelter expense deduction must not exceed:

(i) For the period beginning on the date of enactment of the law and ending on December 31, 1996, $247, $429, $353, $300, and $182 per month, respectively;

(ii) For the period beginning on January 1, 1997, and ending on September 30, 1998, $250, $434, $357, $304, and $184 per month, respectively;

(iii) For fiscal years 1999 and 2000, $275, $478, $393, $334, and $203 per month, respectively; and

(iv) For fiscal year 2001 and each subsequent fiscal year, $300, $521, $429, $364, and $221 per month, respectively.

This final rule makes corresponding changes to the regulations at 7 CFR 273.9(d)(8).

Maximum Allotments: Section 804 of PRWORA amended section 3(o) of the Act (7 U.S.C. 2012(o)) by providing that on October 1, 1996, and each October 1 thereafter, the Department must adjust the cost of the maximum allotment to reflect the cost of the Thrifty Food Plan in the preceding June, and round the result to the nearest lower dollar increment for each household size, except that on October 1, 1996, the Secretary was not allowed to reduce the cost of the maximum allotment in effect on September 30, 1996.

Accordingly, this final rule amends 7 CFR 273.10(e)(4)(ii) to provide that effective October 1, 1996, the maximum food stamp allotments must be based on 100% of the cost of the TFP, as defined in section 271.2, for the preceding June, rounded to the nearest lower dollar increment, except that on October 1, 1996, the allotments may not fall below those in effect on September 30, 1996.

In addition, we are removing 7 CFR 273.10(e)(4)(ii)(A) through (F), as these paragraphs, which provide for the adjustment of the TFP for the years 1983 through 1995, are outdated.

Aid to Families with Dependent Children: Section 101 of PRWORA block granted this program to the States and renamed it the Temporary Assistance for Needy Families (TANF) program. Therefore, the terms “Aid to Families With Dependent Children” and its acronym, “AFDC”, are obsolete. Section 109 of PRWORA made conforming amendments to the Act by replacing the obsolete terms with a reference to assistance under a State program funded under part A of title IV of the Social Security Act, the provision that authorizes TANF.

Accordingly, this rule amends Subchapter C by replacing the words “Aid to Families with Dependent Children” with “Temporary Assistance for Needy Families”, by replacing “AFDC” with “TANF”, and by replacing the words “Aid to Families with Dependent Children (AFDC)” with “Temporary Assistance for Needy Families (TANF)”.

Child support payments: As required by section 5 of the Act prior to PRWORA, the current regulations at 7 CFR 273.9(c)(12) provide that the State agency has the option to exclude from unearned income up to $50 monthly of title IV-D child support payments in cases where such payments are received by the households from the title IV-D support agency responsible for collecting such child support payments on behalf of AFDC recipients. Section 109 of PRWORA amended section 5 of the Act by removing this exclusion. This rule removes 7 CFR 273.9(c)(12) and renumbers (c)(13) through (c)(17) accordingly.

As required by section 5 of the Act prior to PRWORA, current regulations at 7 CFR 276.2(e)(1) provide that the State agency must pay FNS for the increased dollar value of coupon allotments resulting from providing households with an income exclusion for child support payments as described in § 273.9(c)(12). Section 109 of PRWORA amended section 5 of the Act by removing the payback. Accordingly, this rule removes 7 CFR 276.2(e) in its entirety and removes the last two sentences of paragraph (2).

As stated in the preamble to the proposed rules, we instructed State agencies through agency directive to implement the provisions of PRWORA without waiting for formal regulations. The amendments to the definition of “Homeless individual” in § 271.2, and the amendments to § 273.1(b)(1)(ii) and § 273.2(i)(3)(i) and (i)(3)(ii) were to be implemented August 22, 1996. The amendments to § 273.8(f)(1) and § 273.10(e)(4)(ii) were to be implemented October 1, 1996. The amendment to § 273.9(d)(8) was to be implemented January 1, 1997. The remaining amendments in this rule, with two exceptions, must be implemented no later than January 1, 2001. The amendments to § 273.1(b)(1)(iii), and § 273.8(e)(3)(i)(A), must be implemented no later than March 1, 2001. After implementation, State agencies must adjust the cases of ongoing households at the next recertification, at household request, or when the case is next reviewed, whichever comes first. If implementation of the above Act or this rule is delayed, benefits must be restored, as appropriate, in accordance with the Food Stamp Act.

Quality Control. Variances resulting from implementation of the provisions of this final rule will be excluded from error analysis for 120 days from the required implementation date. State agencies that implement the provisions before the required implementation date must notify the appropriate FNS regional office before implementing that they wish the variance exclusion period to begin with the actual implementation, as provided in 7 CFR 275.12(d)(2)(vii)(A). The exclusionary period will begin with the required implementation date, if the State agency does not notify the appropriate regional office.

This rule has been determined to be significant and was reviewed by OMB under Executive Order 12866.

The title and number of the Federal Assistance Program, as found in the Catalog of Federal Domestic Assistance, to which this rule applies, are Commodity Loans and Purchases—10.051.

This final rule has been reviewed in accordance with Executive Order 12988. The provisions of this rule do not preempt State laws, are not retroactive, and do not involve administrative appeals.

It has been determined that the Regulatory Flexibility Act is not applicable to this final rule since neither the Farm Service Agency (FSA) nor the Commodity Credit Corporation (CCC) is required by 5 U.S.C. 553 or any other provision of law to publish a notice of proposed rulemaking with respect to the subject of these determinations.

The amendments to 7 CFR parts 723 and 1464 set forth in this final rule do not contain information collections that require clearance by the Office of Management and Budget under the provisions of 44 U.S.C. chapter 35.

This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This final rule is issued pursuant to the provisions of the 1938 Act and the 1949 Act.

In accordance with section 312 of the 1938 Act, for tobaccos other than flue-cured tobacco and burley tobacco, the Secretary of Agriculture is required to proclaim not later than March 1 of any marketing year (MY) a national marketing quota for those tobaccos for which marketing quotas have been approved in the prior 3 years. A referendum on quotas for each kind is held every 3 years.

On March 1, 2000, the Secretary determined and announced the national marketing quotas and price support levels for the 2000 crops of fire-cured (type 21), fire-cured (types 22-23), dark air-cured (types 35-36), Virginia sun-cured (type 37), and cigar-filler and binder (types 42-44 and 53-55) tobaccos. A number of related determinations were made at the same time which this final rule affirms. And, because the 1999 MY was the last of 3 consecutive years of quota for fire-cured (types 22-23) and dark air-cured (types 35-36) tobacco, the Secretary also announced that referenda would be conducted by mail with respect to those tobaccos.

During the period March 20-24, 2000, eligible producers of fire-cured (types 21-23) and dark air-cured (types 35-36) tobaccos voted in separate referenda to determine whether such producers approved marketing quotas for the 2000, 2001, and 2002 MYs for these tobaccos. Of the producers voting, 92.0 percent favored marketing quotas for fire-cured (types 21-23) tobacco and 90.4 percent favored quotas for dark air-cured (types 35-36) tobaccos. Accordingly, quotas and price support for both fire-cured (types 21-23) and dark air-cured (types 35-36) tobaccos are in effect for the 2000 though 2002 MYs.

Quotas for the other tobaccos covered by this notice were approved in referenda and are still in effect.

Under the 1949 Act, price support is required to be made available for each crop of a kind of tobacco for which marketing quotas are in effect or for which marketing quotas have not been disapproved by producers. With respect to the 2000 crops of the kinds of tobacco that are the subject of this notice, the respective maximum levels of price support for these kinds of tobacco is determined in accordance with section 106 of the 1949 Act. Announcement of the price support levels for these five kinds of tobacco are normally made before the planting seasons. Under the provisions of Section 1108 (c), of Pub. L. 99-272, the price support level announcements do not require prior rulemaking. For the 2000 crops, the price support announcements were made on March 1, 2000, at the same time the quota announcements were made. Quota and price support determinations for burley and flue-cured tobacco are made separately and are the subject of separate notices.

Section 312(b) of the 1938 Act provides, in part, that the national marketing quota for a kind of tobacco is the total quantity of that kind of tobacco that may be marketed such that a supply of such tobacco equal to its reserve supply level is made available during the MY.

Section 313(g) of the 1938 Act provides that the Secretary may convert the national marketing quota into a national acreage allotment for apportionment to individual farms. Since producers of these kinds of tobacco generally produce considerably less than their respective national acreage allotments allow, a larger quota is necessary to make available production equal to the reserve supply level. Further, under section 312(b) of the 1938 Act, the amount of the national marketing quota may, not later than the following March 1, be increased by not more than 20 percent over the straight formula amount if the Secretary determines that such increase is necessary in order to meet market demands or to avoid undue restriction of marketings in adjusting the total supply to the reserve supply level.

Section 301(b)(14)(B) of the 1938 Act defines “reserve supply level” as the normal supply, plus 5 percent thereof, to ensure a supply adequate to meet domestic consumption and export needs in years of drought, flood, or other adverse conditions, as well as in years of plenty. “Normal supply” is defined in section 301(b)(10)(B) of the 1938 Act as a normal year's domestic consumption and exports, plus 175 percent of a normal year's domestic use and 65 percent of a normal year's exports as an allowance for a normal year's carryover.

Normal year's domestic consumption is defined in section 301(b)(11)(B) of the 1938 Act as the average quantity produced and consumed in the United States during the 10 MYs immediately preceding the MY in which such consumption is determined, adjusted for current trends in such consumption. Normal year's exports is defined in section 301(b)(12) of the 1938 Act as the average quantity produced in and exported from the United States during the 10 MYs immediately preceding the MY in which such exports are determined, adjusted for current trends in such exports.

Also, under section 313(g) of the 1938 Act, the Secretary is authorized to establish a national reserve from the national acreage allotment in an amount equivalent to not more than 1 percent of the national acreage allotment for the purpose of making corrections in farm acreage allotments, adjusting for inequities, and for establishing allotments for new farms. The Secretary has determined that the national reserve, noted herein, for the 1999 crop of each of these kinds of tobacco is adequate for these purposes.

On February 14, 2000, a press release was issued in which interested persons were requested to comment with respect to setting quotas for the kinds of tobacco addressed in this rule.

Fifteen written responses were received during the comment period which ended March 1, 2000. A summary of these comments by kinds of tobacco follows:

(1) Fire-cured (type 21) tobacco. One comment was received, recommending a 15-percent reduction in 2000 quotas.

(2) Fire-cured (types 22-23) tobacco. Five comments were received.

Recommendations ranged from a 5-percent to a 7 1/2 -percent increase in MY 2000 quotas.

(3) Dark air-cured (types 35-36) tobacco. Six comments were received. All recommended a 5-percent increase in the quota.

(4) Virginia sun-cured (type 37) tobacco. One comment was received, recommending no change in quota.

(5) Cigar-filler and binder (types 42-44 and 53-55) tobacco. Two comments were received. One recommended a 15-percent reduction in quotas, while the other recommended a 20-percent reduction.

The tobacco program is, through assessments, operated at no net cost to taxpayers other than the costs common to all price support operations. Accordingly, producer comments are given considerable weight in this review. Based on a review of the comments received and the latest available statistics of the Federal Government, which are the most reliable data available, the following determinations were made for the five kinds of tobacco.

The average annual quantity of fire-cured (type 21) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1999 MY was approximately 1.0 million pounds (farm sales weight basis). The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1999 MY was 1.7 million pounds (farm sales weight basis). Both domestic use and exports have trended downward. Because of these considerations, a normal year's domestic consumption has been determined to be 0.7 million pounds, and a normal year's exports have been determined to be 1.62 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 4.8 million pounds (farm sales weight basis).

Manufacturers and dealers reported stocks held on October 1, 1999, of 2.7 million pounds. The 1999 crop is estimated to be 2.5 million pounds. Therefore, total supply for the 1999 MY is 5.2 million pounds. During the 1999 MY, it is estimated that disappearance will total approximately 2.1 million pounds. Deducting this disappearance from total supply results in a 2000 MY beginning stock estimate of 3.1 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 2000, is 1.7 million pounds. This represents the quantity that may be marketed which will make available during the 2000 MY a supply equal to the reserve supply level. More than 95 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 2000 national marketing quota of 1.782 million pounds is necessary to make available production of 1.7 million pounds. As permitted by section 312(b) of the 1938 Act, it was further determined that the 2000 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. This determination took into account the size of last year's quota, the comments, the long storage time for aging purposes for this tobacco, and the possibility of changes in demand over expected demand. Thus, the national marketing quota for the 2000 crop is 2.138 million pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 2000 national marketing quota of 2.138 million pounds by the 1995-99, 5-year national average yield of 1,566 pounds per acre results in a 2000 national acreage allotment of 1,365.26 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 0.85 is determined by dividing the national acreage allotment for the 2000 MY, less a national reserve of 5.58 acres, by the total of the 2000 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of fire-cured (types 22-23) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1999 MY was approximately 19.8 million pounds (farm sales weight basis). The average annual quantity produced in the United States and exported during the 10 MYs preceding the 1999 MY was 15.6 million pounds (farm sales weight basis). Domestic use has trended upward while exports have varied. Because of these considerations, a normal year's domestic consumption has been determined to be 29.9 million pounds, and a normal year's exports have been determined to be 19.0 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 119.3 million pounds (farm sales weight basis).

Manufacturers and dealers reported stocks held on October 1, 1999, of 86.8 million pounds. The 1999 crop is estimated to be 34.0 million pounds. Therefore, total supply for the 1999 MY is 120.8 million pounds. During the 1999 MY, it is estimated that disappearance will total approximately 40.0 million pounds. Deducting this disappearance from total supply results in a 2000 MY beginning stock estimate of 86.8 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 2000, is 32.5 million pounds. This represents the quantity that may be marketed that will make available during the 2000 MY a supply equal to the reserve supply level. Over 90 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 2000 national marketing quota of 35.75 million pounds is necessary to make available production of 32.5 million pounds.

Utilizing section 312(b) of the 1938 Act, it was further determined for the same reason as with fire-cured (type 21) tobacco, that the 2000 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. Thus, the national marketing quota for the 2000 crop is 42.9 million pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 2000 national marketing quota of 42.9 million pounds by the 1995-99, 5-year average yield of 2,494 pounds per acre results in a 2000 national acreage allotment of 17,201.28 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.075 is determined by dividing the national acreage allotment for the 2000 MY, less a national reserve of 37.49 acres, by the total of the 2000 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of dark air-cured (types 35-36) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1999 MY was approximately 9.1 million pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1999 MY was 1.2 million pounds (farm sales weight basis). Both domestic use and exports have been erratic. Because of these considerations, a normal year's domestic consumption has been determined to be 11.3 million pounds, and a normal year's exports have been determined to be 1.5 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 35.3 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1999, of 24.0 million pounds. The 1999 crop is estimated to be 10.6 million pounds. Therefore, total supply for the 1999 MY is 34.6 million pounds. During the 1999 MY, it is estimated that disappearance will total approximately 9.2 million pounds. Deducting this disappearance from total supply results in a 2000 MY beginning stock estimate of 25.4 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 2000, is 9.9 million pounds. This represents the quantity that may be marketed that will make available during the 2000 MY a supply equal to the reserve supply level. Over 90 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a national marketing quota of 10.625 million pounds is necessary to make available production of 9.9 million pounds. In accordance with section 312(b) of the 1938 Act, it has been further determined that the 2000 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. This determination took into account the same factors as with fire-cured (type 21) tobacco and industry preferences. This results in a national marketing quota for the 2000 MY of 12.75 million pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 2000 national marketing quota of 12.75 million pounds by the 1995-99, 5-year average yield of 2,187 pounds per acre results in a 2000 national acreage allotment of 5,829.90 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.05 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 28.61 acres, by the total of the 2000 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of Virginia sun-cured (type 37) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1999 MY was approximately 60,000 pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1999 MY was approximately 100,000 pounds (farm sales weight basis). Both domestic use and exports are erratic. Because of these considerations, a normal year's domestic consumption has been determined to be 79,000 pounds, and a normal year's exports have been determined to be 17,850 pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 259,000 pounds.

Manufacturers and dealers reported stocks held on October 1, 1999, of 50,000 pounds. The 1999 crop is estimated to be 160,000 pounds. Therefore, total supply for the 1999 MY is 210,000 pounds. During the 1999 MY, it is estimated that disappearance will total approximately 80,000 pounds. Deducting this disappearance from total supply results in a 2000 MY beginning stock estimate of 130,000 pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1999, is 129,000 pounds. This represents the quantity that may be marketed that will make available during the 1999 MY a supply equal to the reserve supply level. About three-quarters of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 2000 national marketing quota of 171,000 pounds is necessary to make available production of 129,000 pounds. Thus, the national marketing quota for the 2000 crop is 171,000 pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 2000 national marketing quota of 171,000 pounds by the 1995-99, 5-year average yield of 1,407 pounds per acre results in a 2000 national acreage allotment of 121.54 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.0 is determined by dividing the national acreage allotment for the 2000 MY, less a national reserve of 0.58 acres, by the total of the 2000 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of cigar-filler and binder (types 42-44 and 53-55) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1999 MY was approximately 10.3 million pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1999 MY was less than 100,000 pounds (farm sales weight). Domestic use has trended downward and exports are very small. Thus, a normal year's domestic consumption has been determined to be 5.2 million pounds, and a normal year's exports have been determined to be 70,000 pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 15.1 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1999, of 14.3 million pounds. The 1999 crop is estimated to be 2.8 million pounds. Therefore, total supply for the 1999 MY is 17.1 million pounds. During the 1999 MY, it is estimated that disappearance will total about 5.0 million pounds. Deducting this disappearance from total supply results in a 2000 MY beginning stock estimate of 12.1 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 2000, is 3.0 million pounds. This represents the quantity that may be marketed that will make available during the 2000 MY a supply equal to the reserve supply level. About 80 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 2000 national marketing quota of 3.64 million pounds is necessary to make available production of 3.0 million pounds. This results in a 2000 national marketing quota of 3.64 million pounds. This determination reflects that there are short reserve supplies and takes into account possible changes in expected demand and the fact that even with this adjustment the 2000 quota will be less than the 1999 crop quota.

In accordance with section 313(g) of the 1938 Act, dividing the 2000 national marketing quota of 3.64 million pounds by the 1995-99, 5-year average yield of 2,139 pounds per acre results in a 2000 national acreage allotment of 1,701.73 acres.

Pursuant to the provisions of section 313(g), of the 1938 Act, a national factor of 0.825 is determined by dividing the national acreage allotment for the 2000 MY, less a national reserve of 6.57 acres, by the total of the 2000 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

Because of the results of the producer referendum, marketing quotas shall be in effect for the 2000 MY for both fire-cured (types 21-23) and dark air-cured (types 35-36) tobaccos. In separate referenda held March 20-24, 2000, 92.0 percent of fire-cured producers and 90.4 percent of dark air-cured producers voted in favor of quotas.

For purposes of Executive Order 12866, this rule was determined to be not significant and was not reviewed by the Office of Management and Budget (OMB) under Executive Order 12866.

The Regulatory Flexibility Act is not applicable to this interim rule because neither the FSA nor CCC is required by 5 U.S.C. 553 or any other provision of law to publish a notice of proposed rulemaking with respect to the subject matter of this rule.

It has been determined by an environmental evaluation that this action will have no significant impact on the quality of the human environment. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

The title and number of the Federal Assistance Program, as found in the Catalog of Federal Domestic Assistance, to which this interim rule applies are: Commodity Loans and Purchases—10.051.

This program is not subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983).

This rule has been reviewed in accordance with Executive Order 12988. The provisions of this rule do not preempt State laws to the extent that such laws are consistent with the provisions of this rule. Before any legal action may be brought regarding determinations of this rule, the administrative appeal provisions set forth at 7 CFR part 780 must be exhausted.

The procedures set out in 7 CFR parts 11 and 780 apply to appeals of adverse decisions made under the regulations adopted in this rule.

The information collection reporting requirements contained in the regulations at 7 CFR parts 729 and 1446 include OMB Control Numbers 0560-0006 and 0560-0014 assigned by OMB. The 0560-0006 collection requirements have been approved by OMB and the 0560-0014 collection requirements have been forwarded for approval. The provisions of this rule do not impose new reporting requirements or changes in existing information collection requirements.

An interim rule issued by CCC and FSA on February 18, 2000, initiated changes to regulations at 7 CFR parts 718, 729 and 1446 applicable to the peanut poundage quota and price support programs. The changes were relatively minor and primarily clarified administrative provisions. Some changes corrected erroneous references and, in one case, restated a necessary provision inadvertently omitted in previous rulemaking. Several changes provided peanut producers greater flexibility. The comment period expired March 20. FSA received no comments to the amendments made effective by the interim rule. Accordingly, the provisions of the interim rule have been adopted as final amendments to the regulations.

In addition, this final rule amends § 1446.416 to remove the specific reference to section 22 of the Agricultural Adjustment Act of 1933, as amended (1933 Act), to add references to other authority pursuant to which the President could temporarily suspend restrictions on the importation of peanuts and to amend references to the National Appeals Division that are no longer applicable or appropriate due to statutory and regulatory changes.

Suspension of Restrictions on Imported Peanuts

Under Section 358e(f)(6) of the Agricultural Adjustment Act of 1938 (1938 Act), it is provided that notwithstanding any other provision of the 1938 Act, if the President issues a proclamation under section 404(b) of the Uruguay Round Agreements Act (19 USCS 3601(b)) expanding the quantity of peanuts subject to the in-quota rate of duty under a tariff-rate quota, or under section 22 of the Agricultural Adjustment Act (7 U.S.C. 624), reenacted with amendments by the Agricultural Marketing Agreement Act of 1937, temporarily suspending restrictions on the importation of peanuts, the Secretary shall, subject to such terms and conditions as the Secretary may prescribe, permit a handler, with the written consent of the producer, to purchase additional peanuts from any producer who contracted with the handler and to offer the peanuts for sale for domestic edible use. That provision is administered, for the peanut program, under 7 CFR 1446.616 but until this notice, which updates the regulation, the only statutory provision referred to in the regulation was Section 22 of the Agricultural Adjustment Act. This notice amends 1446.416 so that it will more closely track the provision of Section 358e(f)(6) of the 1938 Act.

The National Appeals Division (NAD) was reorganized by the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994 (Pub. L. 103-345) (the Act) and made subject to the general supervision of and policy direction of the Secretary of Agriculture. As a result of the reorganization, a new part 11 was added to 7 CFR Subtitle A to set forth the provisions for program participants to seek review of an adverse decision. The provisions of 7 CFR 1446.704 no longer accurately reflected the appeal process as set forth in the regulations at 7 CFR part 11 applicable to NAD. In addition, there was no reference to the appeal regulations at 7 CFR part 11. Accordingly, the provisions of § 1446.704 are amended by this final rule to address penalty reductions only and a new section, § 1446.705 is added to direct the public to the appeal regulations at 7 CFR parts 11 and 780.

Because no comments were received on the amendments implemented by the interim rule and since the amendments were minor, clarifying and administrative in nature, the interim rule published at 65 FR 8245 on February 18, 2000, amending 7 CFR parts 718, 729 and 1446, is adopted by this rule as final without change. The changes made are of administrative nature for clarification. We have determined that these changes should be included in this final rule as a delay in implementation would be contrary to the public interest.

This interim final rule has been determined not significant and, therefore, has not been reviewed by the Office of Management and Budget (OMB) under Executive Order 12866.

The Catalog of Federal Domestic Assistance number for this program impacted by this action is 10.768, Business and Industry Loans.

Business and Industry Guaranteed loans are subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. RBS has conducted or will conduct intergovernmental consultation in the manner delineated in 7 CFR part 3015, subpart V, “Intergovernmental Review of Department of Agriculture Programs and Activities.”

This interim rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” In accordance with this rule: (1) All state and local laws and regulations that are in conflict with this rule will be preempted, (2) no retroactive effect will be given this rule, and (3) administrative proceedings of the National Appeals Division (7 CFR part 11) must be exhausted before bringing suit in court challenging action taken under this rule.

This document has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” RBS has determined that this action does not constitute a major Federal action significantly affecting the quality of the human environment, and, in accordance with the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. , an Environmental Impact Statement is not required.

There is no reporting and recordkeeping requirements associated with this interim rule.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C chapters 17A and 25, establishes requirements for Federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. Under section 202 of the UMRA, RBS generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates,” that may result in expenditures to state, local, or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. When such a statement is needed for a rule, section 205 of UMRA generally requires RBS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective, or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for state, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

In compliance with the Regulatory Flexibility Act, RBS has determined that this action would not have a significant economic impact on a substantial number of small entities, because the action will not affect a significant number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). RBS made this determination based on the fact that this regulation only impacts those who choose to participate in the program. Small entity applicants will not be impacted to a greater extent than large entity applicants.

It has been determined under Executive Order 13132, “Federalism,” that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The provisions contained in this rule will not have a substantial direct effect on states or their political subdivisions or on the distribution of power and responsibilities among the various levels of Government.

It has been determined that this rule should be issued as an interim rule, effective immediately (October 30, 2000), but subject to the modification on the consideration of comments that are timely received. As a result of the United States International Trade Commission findings in Investigation Number TA-201-68 on July 7, 1999, the President issued a declaration concerning the lamb meat industry. In response to that declaration, the Secretary of Agriculture is implementing import relief and adjustment assistance measures using, among other things, USDA loan programs to facilitate efforts of the domestic lamb industry to compete with foreign lamb industries.

Market conditions have deteriorated since 1997. Lamb producers have been some of the hardest hit, suffering major losses during 1997 and 1998, due to record high imports of low-price lamb meat; so there is a critical need for immediate action. Furthermore, while the need for immediate assistance is critical, potential harm to other parties, resulting from the issuance of this rule as an interim rule, is expected to be minimal. Therefore, RBS has determined that the notice and public procedure thereon are impracticable, unnecessary, and contrary to public interest.

The purpose of the B&I Guaranteed Loan Program is to improve, develop, or finance business, industry, and employment and improve the economic and environmental climate in rural communities. This purpose is achieved by bolstering the existing private credit structure through the guaranteeing of quality loans that will provide lasting community benefits.

The U.S. sheep industry lacks competitive domestic lamb products at the wholesale and retail levels to effectively compete with imported products. Upgrading processing systems to produce a consumer-ready product at the retail level, that include attributes such as modified atmosphere packaging, portion control, and pre-cooked items, will greatly enhance the domestic lamb industry's ability to compete in the marketplace. B&I loans to upgrade, replace, and install new processing and packaging equipment are eligible under existing program regulations. As part of a USDA initiative to target assistance to the domestic lamb industry, the Agency is setting aside a portion of the B&I Guaranteed Loan Program funds to finance real estate purchases and improvements, working capital, debt refinancing, and equipment in domestic lamb processing and packaging plants. This rule is intended to recognize the set aside of $15 million in fiscal year (FY) 2001, $5 million in FY 2002, and $5 million in FY 2003.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to Pratt & Whitney (PW) Models JT8D-1, -1A, -1B, -7, -7A, -7B, -9, -9A, -11, -15, -15A series turbofan engines was published in the Federal Register on May 5, 2000 (65 FR 26152). That action proposed to require inspections of main fuel pump control shafts for excessive spline wear. Additionally, as terminating action to the inspections, this proposal would require the replacement of the main fuel pump control shaft with parts of improved design, and reworking the main fuel pump impeller, impeller gear train plate assembly, and impeller cover assembly.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One comment requests that the FAA clarify the AD to allow the use of a parts manufacturer approved (PMA) part for the new main fuel pump control shaft. The FAA agrees that the addition of specific part number language will clarifiy the requirements of the AD. Specific part number language has been added to paragraph (e) of the AD.

One comment asks the FAA to clarify the requirements regarding a gearbox change where the entire gearbox is removed and the hardware, including the fuel pump, is transferred to the replacement gearbox. The FAA does not agree that the inspection requirements need to be clarified. In the case of the gearbox change, the accessibility of the main fuel pump is clearly defined in paragraph (e)(1) of this AD and, therefore, requires the inspections detailed in paragraph (a) of the AD.

Two comments request that inspection and replacement intervals be extended or altered. One comment asks that the FAA extend the overhaul limit for main fuel pumps with more that 12,000 hours TIS since overhaul from 2000 hours TIS to 3000 hours TIS. Another comment requests that the overhaul limit for a main fuel pump with over 12,000 TIS be extended to 6,000 hours if a successful inspection is performed on the pump. Extensions are requested based on the impact the additional fuel pump overhauls will have on an operator's fleet. The FAA agrees in part with these comments. It is not the intent of this AD to place any undue burden on an operator's fleet maintenance. The FAA understands from these comments that some operators would prefer to have an alternative plan that precludes performing the inspections and the associated unplanned maintenance that may result from the inspection program. These operators would prefer to be proactive and to expedite the main fuel pump overhauls on a scheduled basis in order to be fully compliant with the required closing action of the AD, rather than having to perform line maintenance inspections. The FAA has determined that this is an acceptable approach and has added an optional accelerated fleet campaign program that will permit the closing action for the AD to be performed for the entire fleet with the highest time main fuel pumps being addressed first. However, the FAA realizes that the optional plan still may not satisfy the fleet impact concerns of all operators. Operators who believe that the actions required by the AD are a significant burden on their operations and who can show that an alternative plan meets the requirements of paragraph (f) of this AD should submit those plans in accordance with the instructions of paragraph (f).

A comment requests that the 1000 hours TIS threshold time for conducting accessibility inspections be extended. The FAA concurs and has extended the initial inspection threshold to 3000 hours TIS for main fuel pumps that have not incorporated the reworked impeller, impeller gear train plate assembly and impeller cover assembly. For main fuel pumps that have incorporated the reworked impeller, impeller gear train plate assembly and impeller cover assembly the initial inspection threshold has been extended to 6000 hours TIS. These changes are reflected in paragraph (a) of this AD.

One comment recommends that the reworked impeller, impeller gear train plate assembly and impeller cover assembly be deemed terminating action to the inspections of paragraphs (a) and (b). This comment asks that the FAA eliminate the replacement of the main fuel pump control shaft as terminating action. The FAA agrees in part. The FAA recognizes that partial incorporation of the terminating actions has some benefit to the main fuel pump control shaft durability. However, the FAA does not agree that it should be terminating action to the inspections. Instead a relaxed inspection and replacement schedule has been added for main fuel pumps that have incorporated the reworked impeller, impeller gear train plate assembly and impeller cover assembly. These changes are reflected in paragraphs (a)(1) and (c)(3)(iii) of this AD.

One comment suggests that, to be consistent with the alert service bulletin, the words “on the engine” be added to the definition of accessibility. The FAA agrees and has modified the definition in paragraph (e) for clarity.

Two comments point out several typographical errors in ASB A6381. The FAA agrees that some typographical errors may exist in the ASB, however, the errors will not prevent proper execution of the instructions in the ASB. The alleged typographical errors will be forwarded to the manufacturer for possible corrections to later revisions of the ASB.

One comment states that the accessibility inspection requirements place a burden on large complex maintenance operations because of the variety of possible locations and fuel pump exposures. The comment suggests that the FAA limit inspections to a shop visit to reduce the training and tooling required for all of the line maintenance facilities. The FAA agrees and has added an optional accelerated fleet campaign in paragraph (d) of this AD for operators who choose not to equip their line maintenance facilities with the necessary training and tooling to perform the inspections of this AD.

One comment requests that the FAA remove JT8D-1, -1A and -1B models from the applicability section of the AD. The FAA does not agree. While these particular models are no longer believed to be operating, they are still listed on the type certificate for the JT8D and, as such, must be included in the applicability section of the rule.

One comment recommends removal of the backlash inspection because of the possibility of missing a worn control shaft. The FAA does not agree. While no inspection program can be 100% effective, this inspection minimizes the possibility of a badly worn main fuel pump control shaft being returned to service prior to being replaced at the next overhaul.

One comment recommends that the AD be changed to state that a certain Argo-Tech parts list number should be referenced as terminating action to the inspections of the AD. The FAA does not agree that a change needs to be made to the AD to reference the Argo-Tech parts list number. The certified parts list for an engine build is based on the engine manufacturer's part numbers. There is no top level part number change on the engine manufacturer's top level part number for the main fuel pump assembly, and, therefore, no change in the AD compliance section. An operator may use the Argo-Tech parts list number as long as they can demonstrate by the incorporation of that number that the appropriate maintenance actions required by the AD have been complied with.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 5,800 engines of the affected design in the worldwide fleet. The FAA estimates that 2962 engines installed on aircraft of US registry would be affected by this proposed AD, that it would take approximately 0.3 work hours to perform the required inspections and 0.5 hours per engine to accomplish the replacements proposed at overhaul, and that the average labor rate is $60 per work hour. Required parts would cost approximately $3,996 per engine. Based on these figures, the total cost impact of the proposed AD on US operators is estimated to be $11,978,328.

This rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this rule.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption “ ADDRESSES. ”

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-03-06, amendment 39-11020 (64 FR 5588, February 4, 1999), which is applicable to all Short Brothers Model SD3-60 SHERPA series airplanes, was published in the Federal Register on June 30, 2000 (65 FR 40549). The action proposed to require a one-time inspection to determine the part number of the power control cable assemblies and pulleys of the engine controls; and replacement of the power control cable assemblies and pulleys (as applicable) with new parts, if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that approximately 28 airplanes of U.S. registry will be affected by this AD, that it will take approximately 15 work hours per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $25,200, or $900 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Raytheon Model DH.125, Model HS.125, Model BH.125, Model BAe.125 Series 800A, Model Hawker 800, Model Hawker 800XP, and Model Hawker 100 series airplanes was published in the Federal Register on June 19, 2000 (65 FR 37922). That action proposed to require leak checks and inspections for corrosion of the pitot/static and stall vent drain valves, and replacement of certain components, if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 900 airplanes of the affected design in the worldwide fleet. The FAA estimates that 585 airplanes of U.S. registry will be affected by this AD, that it will take approximately 4 work hours per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $140,400, or $240 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

In a notice published in the Federal Register of August 24, 1992 (57 FR 38311), FDA announced that a food additive petition (FAP 2A4332) had been filed by Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755. Pfizer, Inc., subsequently announced the sale of the Pfizer Food Science Group and the transfer of the petition to Cultor Food Science, Inc., 430 Saw Mill River Rd., Ardsley, NY 10502. Recently, the petitioner announced a name change from Cultor Food Science, Inc., to Danisco Cultor America, Inc. (Danisco), to reflect the acquisition of the company by Danisco. The petition proposed to amend the food additive regulations in § 172.841 Polydextrose (21 CFR 172.841) to provide for the safe use of polydextrose as a bulking agent, texturizer, or both in tablespreads.

Polydextrose is intended to replace fully caloric ingredients and to produce reduced- or lower calorie and/or lower-fat tablespreads. The proposed use level of polydextrose in tablespreads is 5 to 12 percent with the weighted mean use level estimated to be 8.5 percent. The petitioner contends that this use level makes possible the formulation of lower-calorie tablespreads that compare favorably with prototypes that contain no polydextrose. The petitioner submitted data to substantiate this claim and to demonstrate that the use of polydextrose in tablespreads is technologically self-limiting (Ref. 1).

FDA estimated that the mean consumption of polydextrose from the proposed use in tablespread is 0.7 gram per person per day (g/p/d). The agency considers this consumption insignificant compared to the estimated cumulative intake of polydextrose of 17.5 g/p/d from all currently regulated uses of the additive. Therefore, FDA concludes that there will be a negligible increase in dietary exposure to polydextrose from the issuance of this amendment to the regulation (Ref. 2).

FDA has evaluated data in the petition and other relevant material in its files. Based on this information, the agency concludes that: (1) The proposed food additive use is safe, (2) the additive will achieve its intended technical effect, and therefore, (3) the regulation in § 172.841 should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

On June 1, 1998, the President directed all Federal agencies to use “plain language” in all new documents. In compliance with this directive, FDA has drafted its amendment to § 172.841 using the principles of “plain language” set forth by the President. In amending the regulation, the agency is also making an editorial change by alphabetizing the list of regulated uses of polydextrose.

In the notice of filing, FDA gave interested parties an opportunity to submit comments on the petitioner's environmental assessment. The agency received no comments in response to that notice.

The agency has carefully considered the potential environmental effects of this rule. FDA has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by November 29, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

In a notice published in the Federal Register of August 16, 1999 (64 FR 44530), FDA announced that a food additive petition (FAP 9M4673) had been filed by Caudill Seed Co., Inc., 1402 West Main St., Louisville, KY 40203. The petitioner proposed that the food additive regulations in part 179 Irradiation in the Production, Processing and Handling of Food (21 CFR part 179) be amended to provide for the safe use of sources of ionizing radiation to control microbial pathogens in alfalfa and other sprouting seeds.

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. The additive is not, literally, added to food. Instead, a source of radiation is used to process or treat food such that, analogous to other food processes, its use can affect the characteristics of the food. In the subject petition, the intended technical effect is a change in the microbial load of the food, specifically, a reduction in the number of microbial pathogens in or on seeds for sprouting.

The petitioner submitted published articles and other study reports containing data and information related to seeds for sprouting and other kinds of food in the areas of radiation chemistry, nutrition, toxicology, and microbiology. FDA has fully considered the data and studies submitted in the petition as well as other information in its files relevant to the safety and nutritional adequacy of seeds treated with ionizing radiation prior to sprouting.

The effects of ionizing radiation on the characteristics of treated foods are a direct result of the chemical reactions induced by the absorbed radiation. Scientists have compiled a large body of data regarding the effects of ionizing radiation on different foods under various conditions of irradiation. Research has established that the types and amounts of products generated by radiation-induced chemical reactions (“radiolysis products”) depend on the chemical constituents of the food and on the conditions of irradiation. Furthermore, the principles of radiation chemistry govern the extent of changes, if any, both in the nutrient levels and in the microbial load of irradiated foods. Key factors include the specific nutrient or microorganism of interest, the food, and the conditions of irradiation. See the agency's final rule permitting the irradiation of meat for FDA's discussion of radiation chemistry, nutrition, toxicology, and microbiology related to irradiation of foods under various conditions of use (62 FR 64107, December 3, 1997).

FDA has reviewed the relevant data and information submitted in the petition regarding radiation chemistry as it applies to seeds for sprouting, as well as data readily available and in the agency's files. FDA has concluded that the concentrations and types of radiolysis products formed by the irradiation of seeds for sprouting will be comparable to those products produced by the irradiation of foods of similar composition (Ref. 1). Most of these radiolysis products are formed in very small amounts and are either the same as, or structurally similar to, compounds found in foods that have not been irradiated. Thus, the chemical composition of sprouts grown from irradiated seeds will not differ in any significant manner from sprouts grown from seeds that have not been irradiated.

This petition contained no toxicity studies on the sprouts grown from irradiated seeds. Nonetheless, a review of the agency's data base and submitted published references of toxicological studies related to irradiated foods, combined with the fact that only negligible amounts of radiolysis products are expected to be present in the sprouts that are grown from irradiated seeds for sprouting, show that the estimated exposure of an individual to these radiolytic products will be negligible. Therefore, FDA has determined that no toxicity concerns are raised from the petitioned use of irradiation on seeds for sprouting (Ref. 2).

The purported technical effect of irradiating seeds for sprouting is to control the level of microbial pathogens. FDA evaluated data on the relation between various doses of radiation and the reduction of detectable levels of coliforms generally, and Escherichia coli 0157:H7 and Salmonella serotype Stanley specifically. The petitioner found that, depending on the pathogen and other factors, between 3 and 5 KiloGray (kGy) of irradiation would reduce the amount of pathogens to below detectable levels (Ref. 3). To accommodate the uncertainty of irradiation treatment and dose variation due to absorption by the target, the petitioner requested a maximum irradiation dose of 8 kGy. The agency has determined that irradiation of seeds for sprouting at levels up to 8 kGy will have the desired effect of controlling the levels of microbial pathogens on seeds for sprouting (Ref. 3).

Regarding the nutritional aspects of irradiating seeds for sprouting, it is well documented that protein, fat, and minerals are not significantly altered by irradiation within the given dose range requested in this petition (Ref. 2). The petitioner evaluated the potential loss of vitamins from irradiation of seeds for sprouting. Although there was a great deal of variability in vitamin levels of the seeds tested ( e.g., in studies submitted by the petitioner, vitamin A content of sprouts grown from control seeds was actually lower than that for sprouts grown from irradiated seeds), researchers did not observe any significant losses of any of the vitamins in the resultant sprouts (up to 6 kGy) when compared to nonirradiated controls. Any loss of vitamins, even if it occurs, is expected to be inconsequential when compared to total dietary nutrient consumption (Ref. 2). FDA therefore concludes, based on all the evidence before it, that irradiation of seeds for sprouting under the conditions set forth in the regulation below will not have an adverse impact on the nutritional adequacy of a person's diet.

FDA has also considered whether irradiated seeds for sprouting and sprouts grown from such seeds must bear special labeling. In particular, FDA evaluated the application of § 179.26(c) (21 CFR 179.26(c)) to these products.

Since any permissible use of ionizing radiation on seeds for sprouting must be in conformance with § 179.26(b), the label and labeling of such seeds for sprouting must comply with the requirements in § 179.26(c).

It is important to recognize that in the use of radiation that is the subject of this rule, the irradiated article is not what is generally eaten because the unsprouted seeds are not normally consumed. While irradiation of the seeds for sprouting may cause some changes in the seed (for example, reduced viability of sprouting), the nutritional and flavor characteristics of the sprouts will derive from the fact that they were grown and not from the fact that the seeds were processed by irradiation. Moreover, the agency has no reason to believe that sprouts grown from irradiated seeds will differ in their sensory characteristics from sprouts grown from seeds that have not been irradiated. Therefore, the agency concludes that sprouts grown from seeds that have been irradiated need not be labeled as treated by irradiation where the sprouts themselves have not been irradiated.

Based on the data and studies submitted in the petition and other information in the agency's files, FDA concludes that: (1) The proposed use of irradiation on seeds for sprouting at levels not to exceed 8 kGy is safe, (2) the irradiation will achieve its intended technical effect, and therefore, (3) the regulations in § 179.26 should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by November 29, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents shall be submitted and shall be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display at the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Section 130(a) of FDAMA (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new provision on reports of postmarketing studies (section 506B of the act (21 U.S.C. 356b)). Section 506B of the act provides FDA with additional authority for monitoring the progress of postmarketing studies that applicants have made a commitment to conduct and requires the agency to make publicly available information that pertains to the status of these studies. The following summary describes the obligations of applicants and of FDA under section 506B of the act.

Any applicant that has committed to conduct a postmarketing study for a drug or biological product that is approved for marketing must submit to FDA a report on the progress of the study or the reasons for the failure of the applicant to conduct the study. The applicant must submit the report within a year after the approval of the product and annually thereafter on the anniversary of the product's U.S. approval until the study is completed or terminated. This provision applies to commitments for postmarketing studies that were made on or after enactment of FDAMA, as well as commitments made before enactment of FDAMA.

An applicant must submit an initial report to FDA for study commitments made before November 21, 1997, within 6 months after the effective date of the final rule. Subsequent to the initial report, an applicant must submit an annual report to the agency on the anniversary of the product's U.S. approval. For those applicants required to submit an annual report 7 to 12 months after the effective date of the final rule, the submission of the initial report to FDA within 6 months after the effective date of the final rule is an additional one-time burden.

FDA must develop and publish annually in the Federal Register a report on the status of postmarketing study commitments.

FDA must submit a specific report to Congress by October 1, 2001, that contains the following:

1. A summary of the status reports submitted under section 506B of the act;

2. An evaluation of the performance of applicants in fulfilling their commitments to conduct postmarketing studies under this provision;

3. FDA's timeliness in reviewing these postmarketing studies; and

4. Any legislative recommendations regarding postmarketing studies.

FDA published a proposed rule in the Federal Register of December 1, 1999 (64 FR 67207), that would revise the requirements for annual postmarketing status reports for drug and biological products, and that would require applicants to submit annual status reports for certain postmarketing studies of licensed biological products. The proposed rule described the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. The agency proposed this action to implement section 130 of FDAMA. In proposed §§ 314.81(b)(2)(vii) and (b)(2)(viii), and 601.70(b), FDA would require that a status report for a postmarketing study contain the following information:

1. Applicant's name.

2. Product name. This would include the approved product's established/proper name and proprietary name, if applicable.

3. New drug application (NDA) number, abbreviated new drug application (ANDA) number, biologics license application (BLA) reference number, or supplement number for the approved product.

4. Date of product's U.S. approval.

5. Date of postmarketing study commitment.

6. Description of postmarketing study commitment. For clinical studies, this section would include the purpose of the postmarketing study, the patient population addressed by the study, the number of patients and/or subjects to be included in the study, and the indication and dosage(s) that are to be studied. For nonclinical studies, this section would include the type and purpose of the study (e.g., carcinogenicity study to determine effects of chronic dosing).

7. Schedule for conduct, completion, and reporting of the postmarketing study commitment. This section would include projected dates for initiation of the different phases of the study, for completion of the study, and for submission of the final study report to FDA. If the original schedule is revised under section 9 of this status report, the revised schedule would also be reported in this section (i.e., section 7) in the next status report with a note indicating that the schedule has been revised as reported in the previous status report.

8. Current status of the postmarketing study commitment. Applicants would categorize the status of each postmarketing study using one of the following terms that describe the study's status on the U.S. anniversary date of approval of the application or other agreed date:

a. Pending. The study has not been initiated (i.e., first patient has not been enrolled).

b. Ongoing. The study is proceeding according to, or ahead of, the original schedule described in section 7 of the status report. If a study has been completed but the final study report has not been submitted to FDA, the date the study was completed would be provided.

c. Delayed. The study is proceeding but is behind the original schedule described in section 7 of the status report.

d. Terminated. The study was ended before completion.

e. Submitted. The study has been completed (i.e., last patient finished the protocol) or terminated and a final study report has been submitted to FDA. This category would include the date the final study report was submitted to FDA.

9. Explanation of the study's status. This section would include a brief description of the status of the study, including the number of patients and/or subjects enrolled to date and an explanation of the study's status identified under section 8 of the status report (e.g., delayed due to difficulty in patient accrual, terminated because study would no longer provide useful information, terminated because study is no longer feasible, terminated because of adverse events or other safety issues associated with the use of the product). If the schedule under section 7 of the status report has changed since the last annual report, this section would also include a revised schedule, as well as the reason(s) for the revision.

FDA invited the public to submit written comments on the proposed rule by February 14, 2000, and on the information collection provisions by January 3, 2000. Comments received have been considered and are discussed in section III of this document. No comments were received on the information collection provisions.

To help applicants comply with the requirements of this final rule, the agency is developing a guidance for industry entitled “Reports on the Status of Postmarketing Studies—Implementation of section 130 of the Food and Drug Administration Modernization Act of 1997.” FDA intends to make a draft of this guidance available shortly after publication of this final rule.

This final rule amends parts 314 and 601 (21 CFR parts 314 and 601) to revise the status reports section of postmarketing annual reports for drug and licensed biological products (§§ 314.81(b)(2)(vii) and 601.28). This final rule also amends part 601 to require applicants with licensed biological products to submit a separate annual report that describes the status of certain postmarketing studies (§ 601.70). The major provisions of the final rule are summarized below.

Under §§ 314.81(b)(2)(vii) and 601.70(a), the final rule defines postmarketing studies for which status reports must be submitted to FDA under section 506B of the act as those that concern: (1) Clinical safety; (2) clinical efficacy; (3) clinical pharmacology; and (4) nonclinical toxicology studies that are either required by FDA (e.g., accelerated approval clinical benefit studies, pediatric studies) or committed to by the applicant, in writing, at the time of approval of an application or a supplement or after approval of an application or supplement. FDA is including clinical safety and efficacy and clinical pharmacology studies within the scope of this rule because these types of studies provide the most relevant and useful additional information about the risks, benefits, and optimal use of an approved drug or licensed biological product. FDA also is including nonclinical toxicology studies within the scope of this rule, although such studies are not performed on human subjects, because they are important to the further evaluation of the safety of a marketed drug or biological product. For the purpose of this rule, clinical safety and clinical efficacy studies include human epidemiological studies. Clinical pharmacology studies include pharmacokinetic and pharmacodynamic studies.

Under §§ 314.81(b)(2)(vii) and 601.70, the final rule requires applicants to provide status reports to FDA regarding the progress of the postmarketing studies described above. In addition, under § 314.81(b)(2)(viii), applicants with approved NDA's and ANDA's must provide status reports for any postmarketing study not reported under § 314.81(b)(2)(vii) (e.g., chemistry, manufacturing, controls, product stability). These include postmarketing studies performed by, or on behalf of, the applicant on its own initiative. Section 314.81(b)(2)(viii) does not represent a new reporting burden for applicants with approved NDA's or ANDA's because these applicants are currently required to provide status reports on postmarketing studies in annual reports. FDA is not requiring a similar reporting requirement for postmarketing studies of licensed biologicals in this rule. However, applicants with licensed biological products may voluntarily submit status reports to FDA for postmarketing studies that are not required to be reported under § 601.70.

The agency is committed to harmonizing its reporting requirements for drugs and biologics as much as possible. FDA considered amending its biologics regulations to require the submission of information in postmarketing annual reports currently submitted to the agency by applicants with approved NDA's and ANDA's under § 314.81(b)(2)(i) through (b)(2)(vi). FDA also considered combining postmarketing annual reports required under §§ 601.12(d), 601.28, and proposed 601.70 into a single annual report that would include additional information as required in § 314.81(b)(2)(i) through (b)(2)(vi). However, FDA has determined that requiring such additional information is beyond the scope of this rulemaking, and that it is appropriate, at this time, to harmonize only the drugs and biologics postmarketing annual reporting requirements as they relate to section 506B of the act.

FDA received seven comments on the proposed rule from representatives of pharmaceutical companies and associations. While most comments agreed that the proposed rule appropriately implements section 130 of FDAMA, many comments expressed concern about what information should be included in the status reports and what information should be disclosed to the public.

A discussion of the comments on the proposed rule and the agency's responses follows.

(Comment 1) One comment claimed that the proposed content of status reports exceeds that necessary to determine, as stated in section 130 of FDAMA, “the progress of the study or the reasons for the failure of the sponsor to conduct the study.” The comment said that the agency turns the simple reporting requirement contemplated by FDAMA into a potentially complicated and burdensome exercise. For example, the comment noted that applicants must provide detailed information on a postmarketing study commitment regarding the purpose of the study, the patient population addressed by the study, the indication and dosage(s) that are to be studied, the projected dates for initiation of the different phases of the study and completion of the study, the status of patient accrual, as well as an explanation of the study's status (which would be categorized separately). The comment recommended that the proposed rule be revised to require applicants to simply identify a pertinent postmarketing study commitment and report on its status using a standardized description. The comment added that additional details regarding the postmarketing study commitment should be provided at the discretion of the applicant.

FDA has reviewed the proposed content for status reports and has decided to make several changes. In §§ 314.81(b)(2)(vii)( a )( 6 ) and 601.70(b)(6), the agency is revising the requirements for the “Description of postmarketing study commitment” section of status reports to permit an applicant to determine the type of information that is necessary to identify a postmarketing study commitment. Instead of specifying the elements that would be required to be included in this section, the provision now provides examples of the type of information that applicants may choose to use to describe a postmarketing study commitment. This section, as revised, now reads:

The list of examples does not contain “the number of patients and/or subjects to be included in the study.” However, an applicant is required to include patient accrual information (by providing the number of patients or subjects enrolled to date and the total planned enrollment) in the section requiring an explanation of the study's status.

The agency recognizes that the extent of information necessary to identify various postmarketing study commitments will vary. In most cases, it will be sufficient to use the language provided in the FDA document describing the postmarketing study commitment (e.g., action letter). In other cases, such as when multiple studies are required to fulfill a postmarketing study commitment, additional information is likely to be needed to describe each of the studies.

In §§ 314.81(b)(2)(vii)( a )( 7 ) and 601.70(b)( 7 ), the agency is revising the “Schedule of conduct, completion and reporting of the postmarketing study commitment” section of the status report to require inclusion of only the information that is most important in determining the progress of a study and to clarify that information. FDA is replacing the phrase “projected dates for initiation of the different phases of the study” with the phrase “actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study” and adding “any additional milestones or submissions for which projected dates were specified as part of the commitment.” FDA recognizes study phases may vary depending on the type of study and the study design. Because information on some phases of a study may not be meaningful in establishing study progress, FDA is limiting the information for this section to the projected, or actual, dates for the submission of the study protocol to FDA; for completion of patient accrual into a clinical study or initiation of an animal study; for completion of the study; and for submission of the final study report to FDA. In addition, FDA recognizes that some study commitments include an agreement to report important intermediate timepoints or early study endpoints (e.g., evaluation of surrogate endpoints in a study also measuring clinical benefit). If a study commitment includes reporting at such intermediate timepoints, these timepoints should be included in the projected schedule submitted under §§ 314.81(b)(2)(vii)( a )( 7 ) and 601.70(b)(7).

FDA is requiring that the schedule in this section include actual dates, if they represent milestones that have already been reached, in addition to projected dates. This is particularly appropriate for studies that were started before the effective date of this final rule and for which a particular aspect of the study has already been completed by the effective date. Actual dates are also appropriate if a particular aspect of the study (e.g., submission of study protocol) was completed prior to approval of the drug or agreement on the postmarketing commitment.

The agency is revising the section title “Schedule for conduct, completion and reporting of the postmarketing study commitment” by removing the word “conduct” from the section heading. FDA is making this revision because the word “conduct” is not necessary.

FDA is modifying the section “Current status of the postmarketing study commitment” at §§ 314.81(b)(2)(vii)( a )( 8 ) and 601.70(b)(8), by removing from the paragraph “Ongoing” the requirement to include the date the study was completed, and removing from the paragraph “Submitted” the requirement to provide the date the final study report was submitted to FDA. These date requirements have been added to the section “Explanation of the study's status” at §§ 314.81(b)(2)(vii)( a )( 9 ) and 601.70(b)(9) to consolidate under this section all information providing clarification of the status of individual studies. The paragraph “Pending” has been clarified to state that studies that have not been initiated will be categorized as delayed if the study is behind the original schedule for completion and reporting of the postmarketing commitment. FDA is modifying the paragraph “Terminated” to clarify that this category is to be used if a study has been terminated before completion, but a final study report has not yet been submitted to the agency.

FDA is requiring, as proposed, that annual status reports include the applicant's name, product name, application (NDA, ANDA, BLA, and supplement) number, date of postmarketing commitment, and the product approval date. However, in §§ 314.81(b)(2)(vii)( a )( 4 ) and 601.70(b)(4), the agency is replacing the “Date of product's U.S. approval” section heading with the heading “Date of U.S. approval of NDA, ANDA, or BLA.” This change is being made to clarify identification of the postmarketing commitment because the product may be included in more than one application.

FDA is keeping all other sections of the status reports as proposed, because the agency believes that the information that is being requested in them is necessary to identify a postmarketing study commitment, to establish the progress of a postmarketing study commitment, or to identify the reasons for the failure of the applicant to conduct the study. The agency will use these status reports to review the progress of postmarketing study commitments and to meet its statutory reporting obligations (i.e., its report to Congress on this topic by October 1, 2001, and its annual report in the Federal Register on the status of postmarketing study commitments). FDA anticipates that preparation of a status report for a postmarketing study commitment will not be burdensome. Each status report should contain no more than one page of information that is readily available to the applicant.

(Comment 2) One comment said that much of the information required to be submitted in an NDA annual report under the proposed rule must already be submitted to an investigational new drug application (IND). The comment noted that the risk of duplicative reporting burdens is exacerbated by the fact that NDA and IND anniversary dates may differ and applicants may be required to collect and reconcile information for the same postmarketing studies twice a year. The comment recommended that FDA scale back the scope of the information required to be submitted to the NDA annual report and also permit applicants to reference pertinent sections of an IND and IND annual report in an NDA annual report.

FDA declines to permit applicants to reference their IND and IND annual reports in the status report section of NDA and BLA annual reports. Most of the information contained in these reports is different from the information submitted to the IND and is used by the agency for different purposes. FDA needs the information that is contained in a status report in the prescribed format to meet its statutory reporting obligations. FDA does not believe that preparation of status reports will be unduly burdensome for applicants, and the fact that no comments were submitted on the information collection provisions supports this conclusion.

New §§ 314.81(b)(2)(vii)( b ) and 601.70(e) require the agency to publicly disclose any information concerning a postmarketing study if the agency determines that the information is necessary to identify the applicant or to establish the status of the study, including the reasons, if any, for failure to conduct, complete, and report the study. The proposal stated that information necessary to establish the status of a postmarketing study would include the study protocol, patient accrual rates, reports of unexpected suspected adverse drug reactions, and study results. The proposal also specified that FDA would not publicly disclose trade secrets, as defined in § 20.61 (21 CFR 20.61), or information, described in § 20.63 (21 CFR 20.63), the disclosure of which would constitute an unwarranted invasion of personal privacy.

(Comment 3) Three comments strongly objected to the public disclosure provisions of the proposed rule contending that such disclosure could potentially result in release of confidential and highly sensitive commercial information. One comment said that the “proposed rule directly violates the limits set by FDAMA,” when the proposed rule calls for the disclosure of the study protocol, patient accrual rates, reports of unexpected suspected adverse drug reactions, and study results. The comment claimed that the agency is incorrect when it asserts that this additional information is “necessary to identify the applicant and to establish the status of a study.” Another comment noted that there is an inconsistency in the content of the status reports section and the public disclosure sections of the proposed rule that needs clarification. The content of the status report section is limited to patient accrual and study status, whereas the public disclosure section states that the study protocol and study results will be made public.

The comments recommended that study protocols, reports of unexpected suspected adverse drug reactions, and results of the study not be publicly disclosed. One comment said that clinical protocols are highly proprietary in terms of design and analytical plan and that applicants should only be required to provide a general description of the study for public disclosure. Another comment said that with regard to disclosure of study results in an orphan drug exclusivity situation, the publication of detailed study results may allow competitors to strategically redesign clinical trials in an effort to nullify another company's market exclusivity. The comment also said that detailed knowledge of study results could also lead to potential disputes between competitors via negative advertising. The comment recommended that applicants only be required to provide a brief summary of the study results for public disclosure. Another comment said that disclosure of study results represents bad science because it is generally not appropriate to “peek” at results from a study before its scheduled completion. Another comment said that annual public disclosure of all reports of unexpected adverse drug reactions are inappropriate for epidemiological studies because no scientifically-based conclusions can be drawn when safety reports are reviewed out of context of the study population and without regard to the appropriate controls. However, the comment noted that if any new association is established between a product and a previously unknown adverse reaction, such information should be made public. Another comment noted that if a study is delayed because of low patient accrual rates, despite legitimate efforts to enroll subjects, information posted on a website could negatively affect the company and its ability to complete the commitment.

FDA has considered these comments and agrees that disclosure of the study protocol, reports of unexpected suspected adverse drug reactions, and the results of studies reported under §§ 314.81(b)(2)(vii) and 601.70 are not necessary to achieve the purposes of the rule or section 130 of FDAMA. Section 130 of FDAMA requires the agency to publicly disclose information pertaining to status reports if that information is necessary to identify the applicant and to establish the status of a study, including the reasons, if any, for failure to conduct, complete, and report the study. FDA has, therefore, decided to remove the following sentence from proposed §§ 314.81(b)(2)(vii)( b ) and 601.70(e): “Information necessary to establish the status of a postmarketing study includes the study protocol, patient accrual rates, reports of unexpected suspected adverse drug reactions, and study results.”

For purposes of public disclosure, the agency intends to release information that establishes the status of a study and that is contained in §§ 314.81(b)(2)(vii)( a )( 1 ) through (b)(2)(vii)( a )( 9 ) and 601.70(b)(1) through (b)(9) of the final rule. These sections do not call for study results and FDA does not believe that any information provided by applicants in these sections of a status report would be considered confidential commercial information. However, even if an applicant considers certain information in these sections to be confidential commercial information, section 130(a) of FDAMA would authorize FDA to release such information if it were necessary to identify the applicant or to establish the status of a study, including the reasons, if any, for failure to conduct, complete, and report the study. The agency has decided that a study protocol, study results, and reports of unexpected suspected adverse drug reactions are not information necessary to establish the status of the study. However, the agency expects to continue to receive study protocols and study results since that information is necessary for FDA to determine whether a study commitment has been satisfied. The agency also expects to continue to receive reports of unexpected suspected adverse drug reactions, which are required reports. Other laws, such as the Freedom of Information Act (FOIA), would determine whether the agency would release to the public study protocols, study results, and reports of unexpected suspected adverse drug reactions.

FDA believes that the number of patients who are enrolled in a postmarketing study is an important factor establishing the status of a study. Applicants would provide such information to FDA in status reports, and, under section 130 of FDAMA, patient accrual rates would be considered to be public information.

(Comment 4) One comment claimed that the proposed rule is contrary to FOIA and the Trade Secrets Act. The comment said that FOIA specifically exempts confidential commercial information from public disclosure under 5 U.S.C. 552(b)(4) (so-called “FOIA Exemption 4”) and that the Trade Secrets Act makes it a crime for a Federal employee to disclose any information within the scope of FOIA Exemption 4, including confidential commercial information to the extent that the disclosure is not authorized by law (18 U.S.C. 1905). The comment further asserted that there is nothing in the legislative history of FDAMA to suggest that Congress intended to make public information that would otherwise be exempt from disclosure under FOIA, except to the very narrow extent necessary to identify a sponsor and establish the status of a study. The comment said that the only information that should be required to be disclosed should be basic information to identify the study and sponsor, and the standardized information on the status of a study (or, if applicable, a brief explanation of why a study was not conducted). The comment said that this is the only information that should be posted on FDA's website.

FDA disagrees with the comment because it does not believe that status reports would contain confidential commercial information. In any event, section 130(a) of FDAMA requires the agency to disclose certain information from postmarketing study reports even if that information ordinarily would be considered confidential commercial information. Since section 130(a) of FDAMA requires disclosure, the disclosure would be authorized by law and not prohibited by the Trade Secrets Act. FDA will not disclose any information from postmarketing study reports that is considered a trade secret as defined in § 20.61(a) and section 301(j) of the act (21 U.S.C. 331(j)) or would constitute an unwarranted invasion of personal privacy as defined in § 20.63.

(Comment 5) Two comments wanted to know what information would be disclosed on FDA's website and what format would be used for this purpose. One of the comments asked if a company would have the opportunity to review information before it is posted on the website to ensure that confidential data are not disclosed. Another comment requested that an efficient procedure be established to identify the information that is disclosable. The comment said that applicants should be instructed to include a section in their postmarketing status reports that is specifically intended for public disclosure. The comment noted that this approach is consistent with that adopted recently by FDA for information provided by sponsors to advisory committees in connection with open advisory committee meetings. The comment also noted that if FDA disagrees with an applicant's designation of disclosable information, the agency could then consult with the applicant.

FDA intends to include information on its webpage that is provided to FDA by applicants in their status reports. In the proposed rule, FDA stated that the website will contain, at a minimum, the following information for each postmarketing study commitment: Name of the applicant, application number, product name, dosage form, product use category, type of study, commitment description, commitment date, projected study completion date, current status of commitment, applicant summary of status, annual report due date, and date annual report received. At this time, FDA intends to include this information on FDA's webpage, as well as the date the final study report is received by the agency. In the future, FDA may decide to add or remove types of information from the website or to revise the format. FDA intends to provide a suggested format for postmarketing reports and an example of what information will appear on the agency website in the guidance the agency is developing or on which the agency will solicit public comment. (See section I.C of this document.)

With regard to the submission of a publicly releasable version of the status report by applicants, the agency will not require such submissions at this time. FDA is considering recommending, in guidance, that applicants include with their status reports a publicly releasable version of the report. This version of the status report would facilitate FDA's transmission of information to its website.

(Comment 6) One comment said that the agency needs to clarify that public disclosure does not apply to chemistry, manufacturing, and controls (CMC) studies. Another comment said that the agency needs to clarify that public disclosure does not apply to the log of outstanding regulatory business section of approved NDA annual reports.

The rule has been clarified to require the status of CMC studies that the applicant has agreed to conduct to be reported under § 314.81(b)(2)(viii). FDA would not publicly disclose in its annual Federal Register report or website information concerning postmarketing study commitments submitted in NDA annual reports under §§ 314.81(b)(2)(viii) and 314.81(b)(2)(ix). FDA intends to limit information in the annual Federal Register report and website to information submitted in status reports under §§ 314.81(b)(2)(vii) and 601.70.

Annual reports submitted under § 314.81(b)(2) apply to human drug products with an approved NDA or ANDA. New § 601.70 applies to human licensed biological products that meet the definition of “drug” under the act; it would not apply to biological products that meet the definition of “medical device” under the act. Revised § 314.81(b)(2)(vii) and new § 601.70 require, under section 130 of FDAMA, status reports of postmarketing studies concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that are required by FDA (e.g., accelerated approval clinical benefit studies and pediatric studies) or that the applicant committed to conduct, in writing, either at the time of approval of an application for the drug product or licensed biological product or of a supplement to an application, or after approval of an application or a supplement.

(Comment 7) One comment requested that reporting on the status of nonclinical studies (e.g., preclinical) be made optional for § 601.70.

FDA disagrees with the comment. The agency is requiring that information be provided for postmarketing nonclinical toxicology studies because of their significance in assessing the safety of drug and licensed biological products.

(Comment 8) One comment said that FDA should set some reasonable limit on how far back in time it will require applicants to report on studies that they committed to conduct years before enactment of section 130 of FDAMA but that still remain open. The comment suggested that the agency could remove the status report requirement for a study commitment that was entered into more than 3 years ago.

FDA disagrees with the comment. Section 130 of FDAMA requires that the status of postmarketing study commitments, whether entered into before or after the date of enactment of FDAMA, be reported to FDA annually until the commitment is completed or terminated. Many clinical studies take several years to complete. Studies that applicants committed to conduct several years ago are only now coming to completion and will yield important information about the safety and effective use of the drug or biological product. The agency will monitor an applicant's submission of status reports under §§ 314.81(b)(2)(vii) and 601.70 for any postmarketing study commitment that the agency has formally tracked in agency postmarketing commitment data bases.

In § 314.81(b)(2)(viii), FDA proposed to require that status reports be submitted for any postmarketing study not included under § 314.81(b)(2)(vii) that is being performed by, or on behalf of, the applicant. The applicant was to provide the information prescribed under § 314.81(b)(2)(vii) for each of the postmarketing studies subject to reporting.

(Comment 9) Three comments requested that the agency remove this section from the regulations because section 130 of FDAMA only requires status reports for studies that a company has committed to FDA to perform. One of the comments said that, as an alternative, the agency could limit the studies in this section to those which the applicant committed to FDA that it would conduct.

FDA disagrees with the comment. The agency currently requires that the status of any postmarketing studies performed by, or on behalf of, the applicant be provided in NDA annual reports and FDA will continue to require status reports for these studies. It was not the intent of this rule, however, to expand current reporting requirements for postmarketing studies reported under § 314.81(b)(2)(viii). In considering the comments received, FDA has decided that it is not necessary to prescribe the content and format for status reports under § 314.81(b)(2)(viii) and has removed this requirement. Section 314.81(b)(2)(viii) and (b)(2)(ix) are retained in this rule due to the reorganization of § 314.81(b)(2)(vii).

(Comment 10) Two comments requested that CMC studies be exempt from inclusion in proposed § 314.81(b)(2)(viii) because there is no purpose in providing such information in this section. One comment said that even though current § 314.81(b)(2)(vii) requires status reports for “any” postmarketing study, existing regulation and guidance have previously established a more narrow definition of the CMC reporting requirement. The comment explained that current § 314.81(b)(2)(iv) states that reports for CMC changes are only required for new information that may affect FDA's previous conclusions about the safety or effectiveness of the drug product and that the guidance for industry on “Format and Content for the CMC section of an Annual Report” specifies only the need to include stability data under current § 314.81(b)(2)(vii). The comment recommended that CMC study information be provided under current § 314.81(b)(2)(iv) so that all the information pertinent to the chemistry review would be consolidated into a single section. Another comment said that reporting the status of CMC studies is not pertinent and repeating this information under proposed § 314.81(b)(2)(viii) is redundant and unnecessary.

FDA disagrees in part with this comment. Section 314.81(b)(2)(vii) currently requires reporting of any postmarketing study. FDA's current guidance for industry states that data accumulated from ongoing stability studies should be included in § 314.81(b)(2)(vii). Therefore, it is clear from existing regulations and guidance that stability studies are to be reported under existing § 314.81(b)(2)(vii) (now § 314.81(b)(2)(viii) of the rule). These reports provide FDA with valuable information regarding the safety and efficacy of products, and FDA has decided to retain this requirement in the final rule. However, FDA has decided to modify § 314.81(b)(2)(viii) to clarify the reporting requirements for CMC studies. FDA will maintain a requirement for reporting data from all ongoing product stability studies including those that are being conducted without a postmarketing study commitment, (e.g., annual stability assessment performed in conformance with 21 CFR 211.166). For other types of CMC studies, FDA is revising § 314.81(b)(2)(viii) to require a status report for only those studies which the applicant has agreed to perform. This section now reads as follows:

Status of other postmarketing studies. A status report of any postmarketing study not included under paragraph (b)(2)(vii) of this section that is being performed by, or on behalf of, the applicant. A status report is to be included for any chemistry, manufacturing, and controls studies that the applicant has agreed to perform and for all product stability studies.

Information from other CMC studies, experiences, investigations, or tests that are not stability studies or the subject of a specific commitment but that provide new information that may affect FDA's previous decisions about product safety and efficacy will continue to be reported under § 314.81(b)(2)(iv).

FDA proposed at §§ 314.81(b)(2)(vii) and 601.70(b) that the status of postmarketing studies be submitted to the agency annually until FDA notifies the applicant, in writing, that the agency concurs with the applicant's determination that the study commitment has been fulfilled or that the study is either no longer feasible or would no longer provide useful information.

(Comment 11) Three comments requested that FDA specify the timeframe for agency review of a final study report and for notifying the applicant whether or not the postmarketing study commitment has been fulfilled or that a commitment is either no longer feasible to fulfill or would no longer provide useful information. One of the comments suggested a 90-day timeframe and another comment suggested a 60-day timeframe.

In general, FDA expects that final study reports for postmarketing study commitments will be submitted to the agency with a supplemental application to modify a product's labeling when the studies support such a change. When they are submitted in support of a supplement, FDA will review the submission under established review times for supplements. (For Prescription Drug User Fee Act (PDUFA) products, see letters from Secretary of Health and Human Services to the Chairman of the Committee on Commerce of the House of Representatives (143 Congressional Record H10886, November 13, 1997), and the Chairman of the Committee on Labor and Human Resources of the Senate (143 Congressional Record S12653, November 13, 1997)). If no supplemental application is submitted or a supplement is submitted for a product not covered by PDUFA, FDA will generally review the final study report and notify the applicant in writing within 1 year of receipt of the report regarding whether it considers the commitment to have been met.

(Comment 12) One comment said that the requirement to continue to submit status reports on terminated postmarketing studies until FDA considers that the study commitments have been fulfilled is too vague. The comment requested clarification of the criteria that the agency would use to deem a study fulfilled.

FDA will review final study reports and determine whether or not the study met the objectives of the commitment. Whether or not the objectives have been met will have to be determined on a case-by-case basis because of the variety of postmarketing study commitments. Once FDA completes its review of the final study report, it will notify the applicant, in writing, of the agency's conclusion. An applicant would be required to submit annual status reports to FDA until it receives written notification that the agency concludes that: (1) The study commitment has been met, or (2) the study is either no longer feasible or would no longer provide useful information.

FDA may conclude that the study is no longer feasible but that the commitment's objectives remain important and can be addressed through a study of modified design. In this case, the original study may be terminated with no further reporting once a new postmarketing study commitment and schedule are agreed upon.

FDA may conclude that even though a study was completed, it failed to meet the commitment objectives; or an applicant may terminate a study that FDA subsequently determines is feasible and would yield useful information. In these cases, the agency may ask the applicant to undertake another study to fulfill its commitment.

(Comment 13) One comment said that FDA's confirmation in writing that a study commitment has been fulfilled could reasonably be accommodated through addition of a suitable field in the Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), which would be completed by FDA at the time that receipt of the annual report is acknowledged. From that point on, the comment said that the status of the postmarketing commitment should be tracked under outstanding regulatory business. The comment noted that this suggestion, intended to reduce the administrative burden on FDA of acknowledging receipt of final study reports, would not remove the need for FDA to confirm in writing that they have evaluated the study report and concur with the applicant's conclusions or proposed action (e.g., submission and approval of a labeling supplement to accommodate study results).

FDA disagrees with this suggestion. The agency will not acknowledge that the postmarketing study commitment has been fulfilled until it has reviewed the final study report and concurs that the commitment has been met. Applicants found to have fulfilled their commitments will be notified in writing. In addition, this information will be acknowledged in the agency's data bases and website.

Current § 314.81(b)(2) requires that an applicant submit an annual report each year within 60 days of the anniversary date of U.S. approval of the application. FDA proposed to require the same submission times at § 601.70(c) for annual progress reports of postmarketing study commitments entered into by applicants with licensed biological products.

(Comment 14) One comment said that, for postmarketing studies that are already underway and for which annual reports are already provided, applicants should be permitted to continue to use the annual reporting cycles that are already established. The comment noted that it submits annual reports based on the anniversary date of the study initiation rather than the anniversary date of U.S. approval.

Current § 314.81(b)(2) requires that NDA annual reports be submitted to the agency within 60 days of the anniversary date of approval of the application. FDA will continue to require that NDA annual reports be submitted within the same timeframe. Applicants would not be permitted to submit NDA or BLA annual reports based on the anniversary date of a study's initiation.

Many drug and licensed biological products have multiple postmarketing studies underway that were initiated on different dates. The submission of annual reports based on the date of study initiation would result in multiple reports in any given year, thereby unnecessarily increasing an applicant's reporting burden and complicating FDA's tracking and review of postmarketing study commitment reports. It is FDA's intent to minimize the reporting burden on industry by requiring only a single annual report for any NDA, ANDA, or BLA product. This single report allows applicants to submit status information on all studies and allows FDA reviewers to review and evaluate at one time the progress of all studies, some of which may be related.

FDA proposed that any final rule that may issue based on the proposed rule become effective 90 days after its date of publication in the Federal Register . Applicants that have entered into a commitment prior to November 21, 1997, to conduct a postmarketing study under proposed § 314.81(b)(2)(vii) or § 601.70 would be required, as mandated by FDAMA, to submit an initial report to FDA within 6 months after the effective date of any final rule that issued based on the proposed rule.

(Comment 15) One comment requested that FDA provide that the effective date of any final rule be 120 days after the date of publication of the rule in the Federal Register . The comment noted that, with the proposed 90-day effective date, an applicant could be required to submit an initial report 5 months following publication of the final rule, depending on the anniversary date of their products. The comment claimed that the 90-day effective date is not consistent with section 130 of FDAMA which indicates that applicants should have 6 months following the issuance of final regulations to submit initial reports on postmarketing study commitments. The comment recommended that the effective date be modified to ensure that all applicants will have at least 6 months to file reports under the new requirements.

FDA does not believe that section 130 of FDAMA requires the agency to give a period of 6 months after issuing a final rule for applicants to prepare a postmarketing study status report. Rather, section 130(a) of FDAMA requires all applicants, regardless of the anniversary date of the approval of their drug, to submit status information for postmarketing study commitments made prior to November 21, 1997, within 6 months of the final rule's issuance. This timely submission of information is necessary to allow FDA to meet its reporting obligation in providing Congress with an evaluation of industry's performance in meeting postmarketing commitment obligations and FDA's performance in reviewing those postmarketing study reports.

However, FDA has considered the comment and is revising the effective date to 120 days after the date of publication of the rule in the Federal Register . Although FDA anticipates the information required to complete an inital report on the progress of postmarketing studies is readily available to the applicant, the agency understands that some applicants may have a greater reporting burden than other applicants due to a larger number of postmarketing commitments. Revision of the effective date will give all applicants a minimum of 4 months to prepare an initial report on their postmarketing commitments. If an applicant chooses to submit the report up to 60 days after the anniversary date of the approval of the drug, the applicant will have 6 months in which to file an initial report.

Once the rule goes into effect, annual reports due on or after the effective date must meet the format and content requirements of this final rule. An applicant who has annual reports due on or after August 27, 2001, will be required to submit a special 6-month report for all commitments made prior to November 21, 1997. This one-time additional report is required if:

(1) The drug or biological product was approved before November 21, 1997;

(2) Postmarketing study commitments were made before November 21, 1997; and

(3) The next annual report is not due until August 27, 2001, or later.

(Comment 16) One comment requested that FDA remove the requirement to submit a separate initial report within 6 months of the effective date of the final rule for pre-FDAMA commitments. The comment asserted that these reports would contain data from a time interval of less than 1 year and that significant resources would be required to prepare such a report as well as for FDA to review the report, which, due to the limited data, would be of minimal value. Another comment said that there is little value in requiring submission of these separate reports and that the requirement should be fulfilled in the next annual report due for each product. The comment claimed that this would also be more compatible with collation and publication of the planned Annual Federal Register Report.

FDA does not accept this suggestion. Section 130(a) of FDAMA requires that an initial report on the progress of postmarketing commitments made prior to November 21, 1997, be submitted to FDA within 6 months of the agency issuing a final rule. Although some information on postmarketing studies may be included in annual reports for new drugs submitted before the effective date of the final rule, these reports may not include all information necessary for FDA to evaluate a study's progress. Also, applicants of approved biological products may not have previously submitted study status information. FDA acknowledges that the special 6-month report may contain limited new data. However, the submission of that data, in the format required by §§ 314.81(b)(2)(vii) and 601.70(b), is necessary to allow FDA to respond in a timely manner to Congress as required in section 130(b) of FDAMA. Therefore, FDA maintains this one-time reporting requirement.

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impact of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1966 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Regulatory Flexibility Act requires agencies to analyze whether a rule may have a significant impact on a substantial number of small entities and, if it does, to analyze regulatory options that would minimize the impact. Section 202 of the Unfunded Mandates Reform Act requires that agencies prepare a written statement of anticipated costs and benefits and before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million (adjusted annually for inflation) in any one year.

The agency has determined that the final rule is not a significant action as defined in the Unfunded Mandates Reform Act, and will not have an effect on the economy that exceeds $100 million in any one year. The analysis below details FDA's estimate of the potential cost and the potential benefit of the rule. Based on FDA's analysis using available data, the agency does not anticipate that the rule will result in a significant impact on a substantial number of small entities.

Currently, applicants holding approved NDA's or ANDA's are required to submit annual reports to the agency that include information on the current status of any postmarketing studies of the drug product performed by, or on the behalf of, the applicant. Although the final rule prescribes the format for the required information, this requirement would add no new economic burden for the majority of NDA and ANDA applicants. About half of the applicants holding approved NDA's or ANDA's with outstanding postmarketing study commitments made prior to the enactment of FDAMA may incur a small cost the first year, if their annual report is due within the last 6 months after the effective date of issuance of the final rule and they must submit one initial report within the first 6 months after the effective date. FDA estimates that: (1) There will be approximately 116 such reports submitted; (2) each report will report on two postmarketing studies, on average; and (3) each report will require about 16 hours (or 8 hours per study) to complete. Assuming an average wage rate of $35 per hour, the estimated, one-time cost of this provision is $64,960.

Applicants with licensed biological products are currently required to submit information on postmarketing studies in pediatric populations in annual reports to the agency. These applicants will incur additional costs to comply with the requirements in this final rule. The agency estimates that about 33 applicants will submit postmarketing status reports (reporting on two postmarketing studies, on average) on approximately 43 approved BLA's annually. As the reporting requirements are not extensive and the information is readily accessible to the applicant, FDA estimates that establishments will require about 16 hours to complete the required information for each report (or 8 hours for each study). Assuming an average wage rate of $35 per hour, the estimated incremental cost of the annual reporting requirement will be $560 per report, for an industry total of $24,080 per year. As with applicants holding NDA's or ANDA's, a few applicants with licensed biological products with outstanding postmarketing study commitments may also incur an additional, one-time cost because they must submit their initial report within the first 6 months after the effective date of the final rule and an annual report within the last 6 months of the year. FDA estimates there will be approximately seven such reports, for a total one-time cost of about $4,000.

The requirements in this final rule will not have a significant economic impact on a substantial number of small entities. The agency neither expects the final rule to result in an increased number of completed postmarketing studies nor believes that applicants will incur significantly increased costs from completing studies earlier than intended, as a result of the reporting, tracking, and disclosure activities implemented by the agency. Because affected applicants holding NDA's and ANDA's must currently submit annual reports to the agency, they already have procedures in place to monitor their postmarketing studies. The additional reporting requirement for applicants holding approved BLA's and the reformatting of the annual reports for applicants holding NDA's and ANDA's would be minimal. To simplify the reporting requirement further, however, the agency will publish a guidance for industry to aid applicants in preparing reports in the proper format (see section I.C of this document).

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

This final rule contains information collection provisions that were reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), and that FDA invited the public to send comments to OMB. No comments were received by OMB on these provisions. A description of these provisions is shown below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing the instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Reporting the Status of Postmarketing Studies for Approved Human Drugs and Licensed Biological Products.

Description: Section 506B of the act provides FDA with additional authority for monitoring the progress of postmarketing studies that companies have made a commitment to conduct and also requires the agency to make the status of these studies publicly available.

Under section 506B(a) of the act, applicants that have committed to conduct a postmarketing study for an approved human drug or biological product must submit to FDA a report of the progress of the study or the reasons for the failure of the applicant to conduct the study. This report must be submitted within 1 year after the U.S. approval of the application and then annually until the study is completed or terminated. Under §§ 314.81(b)(2)(vii) and 601.70(b), information submitted in a status report would be limited to that which is needed to sufficiently identify each applicant that has committed to conduct a postmarketing study, the status of the study that is being reported, and the reasons, if any, for the applicant's failure to conduct, complete, and report the study.

Currently under § 314.81(b)(2), applicants holding an NDA or an ANDA must submit status reports on postmarketing studies for the approved human drug product as part of an annual report to FDA. The agency is amending § 314.81(b)(2)(vii) to specify information that must be included in status reports submitted under section 506B of the act (studies of clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that are required by FDA or that an applicant commits, in writing, to conduct either at the time of approval of an application or a supplement to an application or after approval of an application or supplement). New § 314.81(b)(2)(viii) of the final rule requires status information on any postmarketing study commitments not reported under paragraph (b)(2)(vii) that are being performed by, or on behalf of, the applicant; and paragraph (b)(2)(ix) permits the applicant to list any open regulatory business with FDA concerning the drug product subject to the application. For licensed biological products, FDA is requiring applicants under § 601.70 to submit postmarketing status reports for studies of clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that are required by FDA or that an applicant of a BLA commits to conduct, in writing, at the time of approval of an application or a supplement to an application or after approval of an application or a supplement. FDA is revising § 601.28(c) to require that the status of postmarketing pediatric studies described in new § 601.70 be reported under § 601.70 rather than § 601.28. This final rule is intended to provide FDA with specific procedures for monitoring the progress of postmarketing studies that companies have made a commitment, in writing, to conduct and also to permit the agency to make the status of these studies publicly available.

Description of Respondents: Applicants holding approved applications for human drugs and biological products that have committed to conduct postmarketing studies.

As required by section 3506(c)(2)(B) of the PRA, FDA provided an opportunity for public comment on the information collection requirements of the proposed rule (64 FR 67207). In accordance with the PRA, OMB reserved approval of the information collection burden in the proposed rule stating “FDA shall assess comments received regarding information collection requirements contained in the proposed rule. These comments shall be addressed in the preamble to the final rule.” No letters of comment on the information collection requirements were submitted to OMB.

Under current § 314.81(b)(2), applicants with approved NDA's and ANDA's for human drugs are required to submit to the agency two copies of the annual reports that must include information on the current status of any postmarketing study (OMB control No. 0910-0001).

New § 314.81(b)(2)(vii) expressly requires status information to be provided in a specific format as part of the status reports of postmarketing study commitments (clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology), a subpart of the annual report. Based on past experience, the agency estimates that each applicant holding an approved NDA or ANDA would expend an additional 8 hours to reformat the annual report. This is a one-time burden required under new § 314.81(b)(2)(vii). Based on the number of drug applicants in past years who have committed to conduct postmarketing studies, the agency estimates that this provision would apply to approximately 183 applicants and approximately 462 postmarketing studies.

Based upon information obtained from the Center for Biologics Evaluation and Research's computerized application and license tracking data base, the agency estimates that approximately 33 applicants with 43 approved BLA's have committed to conduct approximately 86 postmarketing studies (clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology) and would be required to submit an annual progress report on those postmarketing studies under § 601.70. Section 601.70 requires postmarketing studies status reports for the first time for all biological products. Previously, status reports were required only for postmarketing studies in pediatric populations. Based on past experience with reporting under § 314.81(b)(2), the agency estimates that approximately 8 hours annually are required for an applicant to gather, complete, and submit the appropriate information for each study (approximately two studies per report). Included in these 8 hours is the time necessary to initially format the status report.

Applicants holding NDA's, ANDA's, and BLA's whose anniversary date of U.S. approval of the application falls within the latter half of the year after the effective date of this final rule are required under section 506B of the act to submit an initial report to FDA for postmarketing studies committed to be conducted prior to November 21, 1997, within 6 months after the effective date of the final rule in addition to the reports required by the final rule. This information collection is a statutory requirement for which the final rule adds no additional burden other than prescribing the format. The burden of setting up the format is calculated under §§ 314.81(b)(2)(vii) and 601.70(b).

The information collection requirements of the final rule have been submitted to OMB for review. Prior to the effective date of the final rule, FDA will publish a document in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection requirements in the final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In FR Doc. 00-24632 appearing on page 57726 in the Federal Register of September 26, 2000, the following correction is made:

1. On page 57726, in the second column, under the EFFECTIVE DATE caption, the date “October 26, 2000” is corrected to read “September 26, 2000.”

The Department of the Air Force is revising our rules on the Release, Dissemination, and Sale of Visual Information Materials of the Code of Federal Regulations (CFRs) (32 CFR part 811) to reflect current policies. This part implements Air Force Instruction (AFI) 33-117, Visual Information Management, and apply to all Air Force activities. This part was published as a proposed rule in the Federal Register on December 28, 1999 (64 FR 72621, FR Doc. 99-33604). Comments were solicited for 60 days ending on February 28, 2000. No comments were received.

The Department of the Air Force is redesignating 32 CFR part 811a as 32 CFR part 813 and revising it to reflect current policies. This part implements AFI 33-117, Visual Information Management, and applies to all Air Force activities. This part was published as a proposed rule in the Federal Register on January 5, 2000 (65 FR 419, FR Doc. 00-235). Comments were solicited for 60 days ending on March 6, 2000. No comments were received.

Section 111 of the Copyright Act, 17 U.S.C., creates a statutory license for cable systems that retransmit to their subscribers over-the-air broadcast signals. Royalty fees for this license are calculated as percentages of a cable system's gross receipts received from subscribers for receipt of broadcast signals. A cable system's individual gross receipts determine the applicable percentages. These percentages, and the gross receipts limitations, are published in 37 CFR part 256 and are subject to adjustment at five-year intervals. 17 U.S.C. 801(b)(2)(A) & (D). This was a window year for such an adjustment.

The Library received two petitions for a rate adjustment and published a Federal Register notice seeking comment on these petitions and directed interested parties to file a Notice of Intent to Participate in a Copyright Arbitration Royalty Panel (“CARP”) proceeding. 65 FR 10564 (February 28, 2000). The Library also designated a 30-day period to negotiate a settlement as to adjustment of the rates. 37 CFR 251.63(a). The Library extended the negotiation period on two separate occasions in Orders dated May 15, 2000, and June 5, 2000. The extensions proved to be successful, as the Library received a joint proposal to adjust the cable royalty fees and the gross receipts limitations.

Pursuant to § 251.63(b) of the CARP rules, the Library published in the Federal Register the proposed adjustments to the percentages of gross receipts paid by cable systems, and the gross receipts limitations. 65 FR 54984 (September 12, 2000). Section 251.63(b) provides that the Library “may adopt the rate embodied in the proposed settlement without convening an arbitration panel, provided that no opposing comment is received by the Librarian [of Congress] from a party with an intent to participate in a CARP proceeding.” 37 CFR 251.63(b). No comments or Notices of Intent to Participate were received, enabling publication of today's final regulations adopting the proposed settlement.

The regulations take effect on July 1, 2000, which means that the new cable rates, and the gross receipts limitations, are applicable to the second accounting period of 2000 and thereafter.

For the reasons set forth in the preamble, the Library amends 37 CFR parts 201 and 256 as follows:

The site to be deleted from the NPL is: White Farm Equipment Landfill site, Charles City, Iowa.

A Notice of Intent to Delete for this site was published in the Federal Register on September 7, 2000 (65 FR 54190). The closing date for comments on the Notice of Intent to Delete was October 10, 2000. No comments were received, therefore, EPA has not prepared a Responsiveness Summary. The EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and it maintains the NPL as the list of those sites. Any site deleted from the NPL remains eligible for fund-finances remedial actions in the unlikely event that conditions at the site warrant such action. Section 300.425(e)(3) of the NCP states that fund-financed actions may be taken at sites deleted from the NPL. Deletion of a site from the NPL does not affect responsible party liability or impede agency efforts to recover costs associated with response efforts.

This is a synopsis of the Commission's Memorandum Opinion and Order adopted September 27, 2000, and released October 6, 2000. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., (202) 857-3805, 1231 M Street, NW., Washington, DC 20036.

On September 26, 1994, NHTSA published a final rule establishing Standard No. 304, Compressed Natural Gas Fuel Container Integrity , which specifies tests and performance requirements regarding the durability, strength, and pressure relief of compressed natural gas (CNG) fuel containers. (59 FR 49010) The September 1994 final rule also specified labeling requirements for CNG fuel containers. The CNG fuel container requirements are based on specifications in ANSI/NGV2, a voluntary industry standard addressing CNG fuel containers which was adopted by the American National Standards Institute (ANSI). 1 One of the performance tests involves subjecting containers to a bonfire test to evaluate their pressure relief characteristics.

NHTSA decided in the September 1994 final rule to specify that No. 2 diesel fuel be used to generate the fire in the bonfire test. The agency indicated that it was specifying No. 2 diesel fuel on an interim basis because of its awareness that environmental problems result from use of this fuel. The agency stated that it would study whether other fuels could be used for the bonfire test.

On December 19, 1994, NHTSA published a supplemental notice of proposed rulemaking (SNPRM) that proposed, among other things, to amend the bonfire test procedures and conditions to allow alternative fuel types. (59 FR 65299) Specifically, the agency proposed that the bonfire test be conducted with any fuel that generates a flame temperature equivalent to that of No. 2 diesel fuel ( i.e. , any fuel that generates a flame temperature of 850 to 900 degrees Celcius (C)). NHTSA requested comments about the appropriateness of using flame temperature to define equivalence among fuel types.

Commenters addressing the issue of bonfire fuel generally supported the proposal. EDO Corporation and Brunswick Composites favored allowing any fuel as long as the specified temperature is maintained. Ford Motor Company commented that the proposal was appropriate, provided the flame characteristics of different fuels are similar. AGA/NGVC also supported the proposal.

On November 24, 1995, NHTSA published a final rule that amended the bonfire test procedures and announced its decision to terminate rulemaking on additional performance requirements for CNG containers that the agency had previously proposed. (60 FR 57943) Specifically, section S8.3.6 was amended to allow the bonfire test to be conducted using any fuel that generates a flame temperature between 850 and 900 degrees C for the duration of the test. The agency stated that the amendment provided greater flexibility in conducting the bonfire test. It further stated that the amendment eliminated a provision that specified the use of a fuel that posed environmental problems.

NHTSA received petitions for reconsideration from the American Automobile Manufacturers Association (AAMA), Ford, Consumers Gas, Powertech (a research and development laboratory), and CNG container manufacturers, including NGV Systems, Pressed Steel Tank (PST), and Lincoln Composites (Lincoln). The petitioners requested that NHTSA amend Standard No. 304 with respect to the requirements for labeling CNG containers and the bonfire test procedures. In a final rule published September 6, 1996, the agency responded to issues associated with the labeling of CNG containers. (61 FR 47086) In today's notice, NHTSA responds to the issues associated with the bonfire test.

Lincoln, Powertech, and NGV Systems stated that the bonfire test procedures in S8.3.6 are not feasible. Section S8.3.6 states that “The fire is generated by any fuel that maintains a flame temperature between 850 and 900 degrees C for the duration of the test, as verified by each of the three thermocouples in S8.3.2 or S8.3.3.” NGV Systems provided test data that indicate that the thermocouple temperatures reached during a bonfire test cannot be verified under the procedures specified in the final rule because of variability in the testing. Lincoln recommended that the agency adopt the 1996 edition of NGV2, which requires that two of the three thermocouples average 590 degrees C (1100 degrees F) over any one-minute interval (except that there would be no temperature requirements if the container vents within five minutes of igniting the fire). Lincoln did not explain why this temperature, which is much lower than the initial requirement of 850-900 degrees, would be sufficient. PST stated that because thermocouples on the container do not register temperatures as high as 850 C and are not constant within the 50 C range during the test, diesel fuel should be specified.

Powertech requested that NHTSA harmonize its requirement with the International Standards Organization's (ISO) proposed standard (CD 11439) and the Canadian Standards Associations' proposed standard (B51-95 (part 2)). Both proposed standards are consistent with the 1996 edition of NGV2 which specifies a minimum fire temperature of 590 degrees C using a thermocouple that is placed directly below the container and is shielded from direct flame impingement. These organizations did not establish a maximum test temperature because of the difficulty in precisely controlling the large-scale fire test conditions. In addition to recommending the adoption of NGV2's bonfire temperature, Lincoln recommended rewording the entire bonfire test procedure in FMVSS No. 304 to make it consistent with the 1996 edition of NGV2. That company further stated that if its recommendation were not accepted, then the bonfire test procedures of the standard should be withdrawn and that the issue of the bonfire procedures should be revisited after NGV2 is completed.

After reviewing the petitions and other available information, NHTSA has decided to amend the bonfire test procedures to be consistent with the ANSI/NGV2 industry standard published in June 1998. That standard specifies that, within five minutes of ignition, the average temperature of two of the thermocouples must be not less than 430 degrees C over each one minute interval for the duration of the test, beginning 5 minutes after the ignition of the fire and ending 20 minutes after ignition. It also calls for placement of three thermocouples one inch below the CNG container, and specifies that temperatures be recorded every 30 seconds after the ignition of the fire. In other words, any two of the three thermocouples must have an average temperature of not less than 430 degrees C over a 60-second interval, i.e. ,

These test procedures will facilitate the testing of CNG containers in several ways, while maintaining the level of safety currently required by Standard No. 304. First, eliminating the current narrow 50 degree C temperature range will make it easier to conduct compliance tests consistent with the temperature specifications of the standard. Data submitted by the petitioners that indicate that the final rule's bonfire test procedures were not feasible because the petitioners could not maintain the temperature specified in the 1995 final rule. Second, specifying that the thermocouples will be placed so that they are suspended below the CNG containers, instead of attached to them as is currently specified in the standard, will increase their accuracy in measuring the flame temperature. Third, specifying a minimum average temperature for the thermocouples will facilitate the use of any type of fuel that can be used to generate the needed heat for the bonfire tests. The temperature specified in the 1995 final rule is the flame temperature for diesel fuel, 850-900 degrees C. This is not practical because the container must reach the flame temperature of the fuel that is burning. At such high temperatures, the CNG container material may be destroyed.

NHTSA's decision to pattern the bonfire test procedures after ANSI/NGV2 is consistent with the National Technology Transfer and Advancement Act (NTTAA), which generally requires Federal agencies to evaluate and use existing voluntary consensus standards  2 in their regulatory activities unless doing so would be inconsistent with applicable law ( e.g. , the statutory provisions regarding NHTSA's vehicle safety authority) or otherwise impractical; see section 12(d) of Pub. L. 104-113. The agency believes that NGV2 is suitable and consistent with the agency's own statutory mandate to be practicable and meet the need for safety. Accordingly, NHTSA has revised the bonfire test procedures to be consistent with the June 1998 version of the ANSI standard.

In addition, NHTSA is making a technical amendment to the Application section (S3) to state explicitly that Standard No. 304 applies to “each passenger car, multipurpose passenger vehicle, truck, and bus that uses CNG as a motor fuel and to each container designed to store CNG as motor fuel on-board any motor vehicle.” While the standard's applicability is stated in S6.1 and S6.2, it was not fully stated in S3.

NHTSA has considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under E.O. 12866, “Regulatory Planning and Review.” Further, this action has been determined to be “nonsignificant” under the Department of Transportation's regulatory policies and procedures. The agency has decided not to prepare a Final Regulatory Evaluation (FRE) because the impacts of these amendments are so minimal as not to warrant preparation of a full regulatory evaluation. The amendments in today's final rule make the bonfire test conditions consistent with a voluntary industry standard. Since the industry is already following that standard, this change does not result in any changes in costs.

NHTSA has also considered the effects of this rulemaking action under the Regulatory Flexibility Act. Based upon the agency's evaluation, I certify that this rule will not have a significant economic impact on a substantial number of small entities. The rationale for this certification is that the amendments will not result in any cost increase or decrease for CNG container manufacturers. NHTSA is aware of approximately ten companies that manufacture CNG containers. Because each CNG container manufacturer is affiliated with a Fortune 500 or other large business, none of them would be considered a small business under the U.S. Small Business Administration's affiliation rule (13 CFR 121.401).

The agency has analyzed this rulemaking in accordance with the principles and criteria contained in Executive Order 13132 and has determined that it does not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The final rule has no substantial effects on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials.

In accordance with the National Environmental Policy Act of 1969, NHTSA has considered the environmental impacts of this rule. The agency has determined that this rule will not have any adverse impact on the quality of the human environment.

This rulemaking does not have any retroactive effect. Under 49 U.S.C. 30103, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the State requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 30161 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

Regulations governing the black sea bass fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is allocated into four quota periods based upon percentages of the annual quota. The quarter 4 (October through December) commercial quota is distributed to the coastal states from Maine through North Carolina. The process to set the annual commercial quota is described in § 648.140.

The initial total commercial quota for black sea bass for the 2000 calendar year was 3,024,742 lb (1,372,000 kg) (65 FR 33486, May 24, 2000). The quarter 4 period quota, which is equal to 19.77 percent of the annual commercial quota, was 540,170 lb (245,017 kg). The quota allocation was adjusted downward (65 FR 50465, August 18, 2000) to compensate for 1999 quarter 4 landings in excess of the 1999 quarter 4 quota, consistent with the procedures in § 648.140. The final adjusted quarter 4 quota was 450,661 lb (204,416 kg).

Section 648.141 requires the Regional Administrator, Northeast Region, NMFS (Regional Administrator), to monitor the commercial black sea bass quota for each quota period on the basis of dealer reports, state data, and other available information to determine when the commercial quota has been harvested. NMFS is required to publish a notification in the Federal Register advising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the black sea bass commercial quota has been harvested and no commercial quota is available for landing black sea bass for the remainder of the quarter 4 period, north of 35°15.3' N. lat. The Regional Administrator has determined, based upon dealer reports and other available information, that the black sea bass commercial quota for the 2000 quarter 4 period has been harvested.

The regulations at § 648.4(b) provide that Federal black sea bass moratorium permit holders agree as a condition of the permit not to land black sea bass in any state after NMFS has published a notification in the Federal Register stating that the commercial quota for the period has been harvested and that no commercial quota for the black sea bass is available. The Regional Administrator has determined that the quarter 4 period for black sea bass no longer has commercial quota available. Therefore, effective 0001 hrs local time, November 1, 2000, further landings of black sea bass in coastal states from Maine through North Carolina, north of 35°15.3' N. lat., by vessels holding commercial Federal fisheries permits are prohibited through December 31, 2000. The 2001 quarter 1 period for commercial black sea bass harvest will open on January 1, 2001. Effective November 1, 2000, federally permitted dealers are also advised that they may not purchase black sea bass from federally permitted black sea bass moratorium permit holders who land in coastal states from Maine through North Carolina, north of 35°15.3' N. lat., for the remainder of the quarter 4 period (through December 31, 2000).

The regulations at § 648.4(b) also provide that, if the commercial black sea bass quota for a period is harvested and the coast is closed to the possession of black sea bass north of 35°15.3' N. lat., any vessel owners who hold valid commercial permits for both the black sea bass and the NMFS Southeast Region Snapper-Grouper fisheries may surrender their black sea bass moratorium permit by certified mail addressed to the Regional Administrator (see table 1 at § 600.502) and fish pursuant to their Snapper-Grouper permit, as long as fishing is conducted exclusively in waters, and landings are made, south of 35°15.3' N. lat. A moratorium permit for the black sea bass fishery that is voluntarily relinquished or surrendered will be reissued upon the receipt of the vessel owner's written request after a minimum period of 6 months from the date of cancellation.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.