In fiscal year 2000, Congress provided no appropriation for AARCC. The AARCC Board of Directors subsequently resigned. This delegation of authority authorizes the Under Secretary for Rural Development, or the designee of the Under Secretary, to exercise decision-making authority over AARCC, the AARCC investment portfolio, and the AARCC revolving fund.

On March 9, 2000, the Delegations of Authority were revised, and the revision reflected a change in title from the Under Secretary for Rural Economic and Community Development to the Under Secretary for Rural Development. In order to maintain consistency, that title change also is reflected in this rule.

This rule relates to internal agency management. Therefore, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required. Further, since this rule relates to internal agency management, it is exempt from the provisions of Executive Order Nos. 12866 and 12988. In addition, this action is not a rule as defined by the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , and, thus, is exempt from the provisions of that Act. Accordingly, as authorized by section 808 of the Small Business Regulatory Enforcement Fairness Act of 1996, Pub. L. No. 104-121, this rule may be made effective upon publication in the Federal Register .

On November 12, 1999, President Clinton signed into law the Nursing Relief for Disadvantaged Areas Act of 1999 (NRDAA), Public Law 106-95. The NRDAA created a new H-1C nonimmigrant category for registered nurses who will work in facilities that serve health professional shortage areas.

The H-1A program was created by the Immigration Nursing Relief Act of 1989 (INRA). While the NRDAA adopts, almost verbatim, many of the provisions of the INRA, there are some differences between the two programs. The NRDAA imposes more restrictions on the types of facilities that may petition for a nonimmigrant registered nurse and requires that these facilities make a greater number of attestations to the Department of Labor (DOL) than did the INRA. Whereas the INRA allowed for an unlimited number of H-1A nonimmigrant visas to be issued, the NRDAA places a state-by-state numerical cap on the number of H-1C nonimmigrant visas that may be issued. Also, unlike the INRA, the NRDAA does not recognize nursing education received in Canada. For the most part, however, the INRA and the NRDAA are identical and, therefore, much of the regulatory language from the H-1A program has been used for the H-1C program.

An H-1C nonimmigrant is an alien who is coming temporarily to the United States to perform services as a registered nurse, who meets the requirements of section 212(m)(1) of the Immigration and Nationality Act (Act), and will perform services at a facility (as defined at section 212(m)(6) of the Act) for which the Secretary of Labor has determined and certified to the Attorney General that an unexpired attestation is on file and in effect under section 212(m)(2) of the Act.

The NRDAA imposed three requirements on an alien seeking H-1C nonimmigrant status. First, the alien must have obtained a full and unrestricted license to practice professional nursing in the country where he or she obtained nursing education, or the alien must have received nursing education in the United States. Second, the alien must have passed an appropriate examination (recognized in regulations promulgated in consultation with the Secretary of Health and Human Services) or have a full and unrestricted license under state law to practice professional nursing in the state of intended employment. Finally, the alien must be fully qualified and eligible under the laws (including such temporary or interim licensing requirements which authorize the nurse to be employed) governing the place of intended employment to engage in the practice of professional nursing as a registered nurse immediately upon admission to the United States and be authorized under such laws to be employed by the facility.

The NRDAA does not specifically designate any particular examination as an “appropriate examination” for the purpose of meeting the eligibility requirements for the H-1C classification. At present, the only “appropriate examination” available for a prospective H-1C alien is the examination offered by the Commission on Graduate of Foreign Nursing Schools (CGFNS). However, the Service may eventually recognize additional examinations for this purpose.

Questions concerning the test offered by CGFNS should be directed to CGFNS. CGFNS can be reached through its internet website, www.cgfns.org.

On September 30, 1996, President Clinton signed the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA), Pub. L. 104-208. Section 343 of IIRIRA created a new ground of inadmissibility at section 212(a)(5)(C) of the Immigration and Nationality Act (the Act) for aliens coming to the United States to perform labor in certain health care occupations. As initially written by Congress, section 343 of IIRIRA provides that any alien coming to the United States for the purpose of performing labor as a health care worker, other than as a physician, is inadmissible unless the alien presents to the consular officer, or, in the case of adjustment of status, the Attorney General, a certificate from the CGFNS, or an equivalent independent credentialing organization approved by the Attorney General in consultation with the Secretary of Health and Human Services (HHS).

Pursuant to the statute, the certificate must verify that: (1) The alien's education, training, license, and experience are comparable with that required for an American health care worker of the same type; (2) they are authentic; (3) the alien's license is unencumbered; (4) the alien has the level of competence in oral and written English considered by the Secretary of HHS, in consultation with the Secretary of Education, to be appropriate for health care work of the kind in which the alien will be engaged, as shown by an appropriate score on one or more nationally recognized, commercially available, standardized assessments of the applicant's ability to speak and write English; and, finally, (5) if a majority of states licensing the profession in which the alien intends to work recognize a test predicting the success on the profession's licensing or certification examination, the alien has passed such an examination.

The NRDAA created an alternative certification requirement at section 212(r) of the Act for certain nurses, which may include some H-1C nonimmigrant aliens. Section 212(r) of the Act provides that section 212(a)(5)(C) of the Act shall not apply to a nurse who presents to the consular office (or in the case of adjustment of status, the Attorney General) a certified statement from the Commission on Graduates of Foreign Nursing Schools (CGFNS) (or an equivalent independent credentialing organization approved by the Attorney General and the Secretary of Health and Human Services) which certifies that:

• The alien has a valid and unrestricted license as a nurse in the state where the alien intends to be employed and such state verifies that the foreign licenses of alien nurses are authentic and unencumbered;

• The alien has passed the National Council Licensure Examination (NCLEX);

• The alien is a graduate of an English-language nursing program in a country designated by the CGNFS which was in operation on or before the date of enactment of the NRDAA or has been approved by unanimous agreements by the CGFNS and any other approved credentialing organizations.

The Service has granted authorization to three organizations to issue certificates to foreign health care workers pursuant to section 343 of IIRIRA through the publication of two interim rules. However, the two interim rules limited these organizations to issuing certificates to aliens in only three occupations who are coming to the United States as immigrants or who are applying for adjustment of status. Due to a number of problems implementing a final regulation fully implementing section 343, the Service has exercised its authority under section 212(d)(3) and waived the requirements of section 343 of IIRIRA as it relates to nonimmigrant aliens. The Service will continue to waive section 343 for nonimmigrant aliens until such time as the Service promulgates a final rule implementing section 343 of IIRIRA in full.

In order to avoid confusion for both health care workers and medical facilities, and to ensure equitable administration of these two statutory provisions, the Service will include the proposed regulations implementing section 212(r) in the soon to be published proposed rule implementing section 343 of IIRIRA. As a result, the Service will exercise the authority granted to it in section 212(d)(3) of the Act and waive section 212(r) for nonimmigrant aliens until publication of a final rule implementing both section 343 of IIRIRA and section 212(r) of the Act.

An H-1C petition may be filed by a United States employer hospital (facility) which has filed an attestation with the DOL. The INS will rely on the determination made by DOL when it (DOL) reviews the attestation. The facility must have attested that:

• As of March 31, 1997, it was located in a health professional shortage area (as defined in section 332 of the Public Health Service Act (42 U.S.C. 254e));

• Based on its settled cost report for the period beginning in FY 1994, it had:

1. At least 190 licensed acute care beds;

2. At least 35 percent of its inpatients days were for patients entitled to Medicare; and

3. At least 28 percent of its inpatient days were for patients who were entitled to Medicaid.

Yes. The facility must also attest to the DOL that:

• The employment of the H-1C alien will not adversely affect the wages and working conditions of other nurses similarly employed;

• The H-1C alien will be paid the wage rate for registered nurses similarly employed by the facility;

• There is not a strike or lockout in the course of a labor dispute;

• It did not lay off and will not lay off a registered nurse already employed by it within the period beginning 90 days before and ending 90 days after the date of filing of any H-1C petition;

• The employment of the H-1C alien is not intended to influence an election for a bargaining representative for registered nurses of the facility;

• At the time of filing of the petition, notice of filing has been provided by the facility to the bargaining representative of the registered nurses at the facility or, where there is no such bargaining representative, notice of the filing has been provided to the registered nurses employed at the facility through posting in conspicuous locations;

• It will never employ a number of H-1C aliens that exceeds 33 percent of the total number of registered nurses employed by it;

• The H-1C alien will not be authorized to perform nursing services at any worksite other than the worksite controlled by it, and

• It will not transfer the alien from one worksite to another.

The facility must also attest that it has taken steps to recruit and retain registered nurses who are United States citizens or immigrants. These steps include, but are not limited to:

• Operating a training program for registered nurses at the facility or financing (or providing participation in) a training program for registered nurses elsewhere;

• Providing career development programs and other methods of facilitating health care workers to become registered nurses;

• Paying registered nurses wages at a rate higher than currently being paid to registered nurses similarly employed in the geographic area; or

• Providing reasonable opportunities for meaningful salary advancement by registered nurses.

These steps do not need to have been taken by the facility prior to the enactment of the NRDAA.

A copy of the attestation shall be provided, within 30 days of the date of filing, to registered nurses employed at the facility on the date of its filing. The attestation shall apply to all H-1C petitions filed during the 1-year period beginning on the date of its filing with the Secretary of Labor if the facility states in each petition that it continues to comply with the conditions in the attestation. These attestation requirements are explained further in regulations issued by the Secretary of Labor at 20 CFR Part 655, subparts L and M, 65 FR 51138 (Aug. 22, 2000).

Yes. An attestation will expire either at the end of the 1-year period beginning on the date of its filing with the Secretary of Labor or at the end of the period of admission of the last H-1C alien with respect to whose admission it applies, whichever is later. With regard to an individual alien, the attestation remains valid as long as the alien is employed by the facility that made the attestation.

The NRDAA establishes that, if the Secretary of Labor finds that a facility (for which an attestation is made) has failed to meet a condition attested to, or that there was a misrepresentation of material fact in the attestation, the Secretary may impose such administrative remedies (including civil monetary penalties in an amount not to exceed $1,000 per nurse per violation, with the total penalty not to exceed $10,000 per violation) as the Secretary of Labor deems appropriate. The Secretary of Labor shall also notify the Attorney General of such finding and provide a recommendation regarding the length of the debarment period. The Service will give considerable weight to the Secretary's determination. Upon receipt of such notice, the Service will make a final determination as to the length of the period of debarment. The Service shall not approve H-1C petitions filed by that facility for aliens to be employed by the facility for a period of at least one year.

All H-1C petitions must be filed on Form I-129 Petition for a Nonimmigrant Worker at the Vermont Service Center (VSC).

The petitioning facility must submit the following documents at the time the H-1C petition is filed:

• A current copy of the DOL's notice of acceptance of the filing of its attestation on Form ETA 9081;

• A statement describing any limitations which the laws of the state or jurisdiction of intended employment place on the alien's services; and

• Evidence that the alien(s) named on the petition meets the definition of a registered nurse as defined at 8 CFR 214.2(h)(3)(i)(A), and satisfies the requirements for an H-1C nonimmigrant in section 212(m)(1) of the Act.

Yes. An alien admitted to the United States as an H-1C nonimmigrant alien can change H-1C employers provided that the alien has not reached the limit on his or her maximum period of stay in the United States. The maximum period of stay for an H-1C nonimmigrant is 3 years. An H-1C petition filed on behalf of an alien in the United States in H-1C status may be approved for a period of time not to exceed the third anniversary of the alien's initial admission into the United States. In addition, H-1C petitions filed by a subsequent facility will be counted against the numerical limitation for the state of the alien's intended employment if the subsequent employment is in a different state.

An H-1C nonimmigrant alien may not change employers until such time as the Service approves a new H-1C petition filed in the alien's behalf by the new employer.

The statute provides that the period of admission to the United States for H-1C nonimmigrant aliens is 3 years. The Service interprets this 3-year period of time to represent the maximum period of admission for an H-1C alien. The alien's maximum period of admission begins on the date of the alien's initial admission to the United States and ends on the third anniversary of that date. Temporary absences outside of the United States for either business or personal reasons count towards the alien's maximum period of admission. Once an H-1C alien has reached the maximum period of admission in the United States, he or she is ineligible to receive an extension of temporary stay.

Yes. While an H-1C alien should be admitted to the United States for a maximum period of 3-years, there will be situations where an H-1C alien may not be able to be admitted for the 3-year period of time. For example, the alien's passport may not be valid for the required length of time (See section 212(a)(7)(B)(I) of the Act), or the alien may not be able to depart from his or her home country and apply for admission to the United States on the date that the H-1C petition becomes valid.

In no situation may the alien's stay be extended beyond the third anniversary of the alien's initial admission to the United States.

In general, all H-1C aliens should be admitted for a period of three years, if otherwise eligible under statute and regulation. In the case of an alien admitted to the United States for a period of time less than 3 years, the facility may file an I-129 petition to extend the alien's stay.

While the statute limits the period of employment for an H-1C alien to a maximum of 3 years, an alien may work for a petitioning employer for a period less than 3 years, depending upon the needs of the employer and the alien.

No. The statutory language of the NRDAA clearly limits the stay of an H-1C alien to a period of three years. To allow an alien to circumvent this 3-year limitation merely by leaving the United States and immediately returning defeats the purpose of the 3-year limitation on the alien's period of admission.

The total number of H-1C nonimmigrant visas issued in each fiscal year shall not exceed 500. This is the national cap that cannot be exceeded in a fiscal year. In addition to the national cap of 500, the NRDAA also imposes caps on individual states on the basis of the state's population. The number of visas issued shall not exceed 25 for states with populations of less than 9 million, based upon the 1990 decennial census of population, and shall not exceed 50 for states with populations of 9 million or more. Based on the 1990 decennial census of population, the states with populations of 9 million or more are California, Florida, Illinois, Michigan, New York, Ohio, Pennsylvania, and Texas.

If the total number of visas available during the first three quarters of a fiscal year exceeds the number of qualified H-1C aliens, the excess visas shall be allocated to states, regardless of the states' numerical cap, during the last quarter of the fiscal year. Once the 500 national cap has been reached, the Service will reject any new petitions subsequently filed requesting a work start date prior to the first day of the next fiscal year.

H-1C petitions will be adjudicated in order of receipt. If a state reaches its annual cap during the first three quarters of a fiscal year, pending H-1C petitions for employment in that state will be put on hold until the fourth quarter of the fiscal year. If the national 500 cap has not been reached by the start of that quarter, then those petitions that were put on hold will be adjudicated at that time.

During the final quarter of the fiscal year, all unused H-1C nonimmigrant visas that have accrued during the previous three fiscal year quarters will be distributed to the next approvable petition, in order of receipt, regardless of whether the H-1C alien will be employed in a state that has already reached its numerical cap.

If a petition is put on hold because the H-1C alien will be employed in a state that has already reached its annual cap prior to the fourth quarter of a fiscal year, and the Service then approves 500 petitions nationwide prior to the fourth fiscal year quarter, or prior to adjudication of the held petition during that fiscal year, that petition will continue to be held pending the allocation of new visas in the next fiscal year.

The Service will publish quarterly reports concerning the number of approved H-1C petitions, by state, on the Service's website at www.ins.usdoj.gov. Again, once the 500 national cap has been reached, the Service will reject any new petitions subsequently filed requesting a work start date prior to the first day of the next fiscal year.

The first petition filed by a facility for an H-1C counts towards the numerical limitation for the state of the alien's intended employment, regardless of whether the alien was, or currently is, in H-1C status.

The purpose of the NRDAA is to alleviate nursing shortages in health professional shortage areas in the United States. As such, any alien admitted to the United States as an H-1C nonimmigrant must meet all licensing requirements for the state of intended employment and must continue to perform the duties of a registered nurse as an H-1C. Facilities and nurses are expected to comply with the licensing standards established by the state licensing board. Facilities are also required, pursuant to § 214.2(h)(11)(i)(A), to notify the Service if there are any changes in the terms or conditions of employment of the H-1C alien. The Service must be notified when an H-1C nurse is no longer licensed as a registered nurse in the state of employment.

If an H-1C petition is revoked because the alien never assumed his or her employment with the petitioning facility, that number will be returned to the pool of unused numbers and will then be made available to the state in which the petitioning facility is located in the final quarter of the fiscal year in which the petition was revoked. H-1C petitions that are revoked by the Service where the alien worked for the petitioning facility will not be returned to the pool of unused numbers.

Yes. The NRDAA allows for a petitioning facility to include more than one alien nurse on a single petition.

If the number of alien nurses included in a petition exceeds the number available for the remainder of a fiscal year, the Service shall approve the petition for the beneficiaries to the allowable amount in the order that they are listed on the petition. The remaining beneficiaries will be considered for approval in the subsequent fiscal year.

Yes. The H-1C classification will expire 4 years after the date that the regulations are first promulgated. As such, all petitions for H-1C alien nurses must be filed by June 13, 2005. In addition, an H-1C nurse may not be admitted to the United States beyond June 13, 2005.

No. Unlike the H-1B and H-2B nonimmigrant classifications, the NRDDA does not require a facility to pay the H-1C alien's return trip transportation home.

The Service's implementation of this rule as an interim rule, with provision for post-promulgation public comment, is based upon the “good cause” exceptions found at 5 U.S.C. 553(b)(B) and (d)(3). The reason and necessity for immediate implementation of this interim rule without prior notice and comment is that the NRDAA became effective immediately upon enactment on November 12, 1999, and allows for facilities in medically underserved areas of the United States to petition for registered nurses. Sections 2(d) and (3) of the NRDAA, moreover, explicitly contemplate, and so implicitly authorize, the promulgation of this rule as an interim regulation. The Service is also aware of the effect that delays in issuing these interim regulations may have on public health in underserved areas of the United States.

For these reasons, the Commissioner of the Immigration and Naturalization Service has determined that delaying the implementation of this rule would be unnecessary and contrary to the public interest, and that there is good cause for dispensing with the requirements of prior notice. However, the Service invites public comment on this interim rule and will address those comments prior to the implementation of the final rule.

The Commissioner of the Immigration and Naturalization Service, in accordance with the Regulatory and Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule will facilitate the hiring of a limited number of nonimmigrant nurses for a temporary period of time to work in facilities serving health care professional shortage areas. These nurses are not considered small entities as that term is defined in 5 U.S.C. 601(6).

This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

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

This rule is considered by the Department of Justice, Immigration and Naturalization Service, to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to the Office of Management and Budget (OMB) for review.

This regulation will not 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This interim rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

The information collection requirement of Form I-129 contained in this rule previously was approved for use by the Office of Management and Budget (OMB). The OMB control number for this collection is 1115-0168.

This interim rule permits certain hospital facilities to file petitions on behalf of nonimmigrant registered nurses to work in underserved areas. In addition to the Form I-129, the petitioning facilities also must submit other documentation, including a current copy of the DOL's notice of acceptance of the filing of the facility's attestation on Form ETA 9081; a statement describing any limitations which the laws of the state or jurisdiction of intended employment place on the alien's services; and evidence that the alien(s) named on the petition meets the definition of a registered nurse as defined at 8 CFR 214.2(h)(3)(i)(A), and satisfies the requirements for an H-1C nonimmigrant in section 212(m)(1) of the Act. This additional documentation is considered an information collection.

Accordingly, the Service has submitted an information collection request to the Office of Management and Budget (OMB) for emergency review and clearance in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Emergency review and approval has been granted by OMB. The emergency approval is only valid for 180 days.

All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to the Immigration and Naturalization Service, Policy Directives and Instructions Branch, 425 I Street, NW., Suite 4034, Washington, DC 20536; Attention: Richard A. Sloan, Director, (202) 514-3291.

We request written comments and suggestions from the public and affected agencies concerning the proposed collection of information. Any comments on the information collection must be submitted on or before August 10, 2001. Your comments should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of the information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(1) Type of information collection: New.

(2) Title of Form/Collection: Petitioning requirements for H-1C nonimmigrant classification.

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: No form number (File number OMB-26), Immigration and Naturalization Service.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Individuals or households. Section 101(a)(15)(H)(i)(c) of Act allows petitioning hospitals to import registered nurses to work at those hospitals as nonimmigrants. The information collection is necessary in order for the Service to make a determination that the eligibility requirements and conditions are met regarding the nurse/beneficiary.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 1,000 respondents at 2 hours per response.

(6) An estimate of the total of public burden (in hours) associated with the collection: Approximately 4,000 burden hours.

If additional information is required contact Richard A. Sloan, Director, (202) 514-3291.

9. Section 299.1 is amended in the table by revising the entry for Form “I-129” to read as follows:

On March 23, 2001, the Federal Aviation Administration (FAA) issued AD 2001-06-16, amendment 39-12163 (66 FR 17499, April 2, 2001), which applies to all McDonnell Douglas Model DC-9-80 series airplanes and Model MD-88 airplanes. That AD supersedes an existing AD to continue to require revisions to the Airplane Flight Manual (AFM) and installation of inspection aids on the wing upper surfaces. That AD also requires, among other actions, installation of an overwing heater blanket system or primary upper wing ice detection system, and installation of a heater protection panel or an equipment protection device on certain overwing heater blanket systems. That AD was prompted by incidents in which ice accumulation on the wing upper surfaces shed into the engines during takeoff. The actions required by that AD are intended to prevent ice accumulation on the wing upper surfaces, which could result in ingestion of ice into one or both engines and consequent loss of thrust from one or both engines.

As discussed in the preamble of AD 2001-06-16, the FAA deleted paragraph (f)(1)(iii) and other subparagraphs of the supplemental NPRM from the final rule. Although we deleted these paragraphs, we inadvertently did not update an associated paragraph reference in paragraph (d)(2)(ii)(A) of AD 2001-06-16. As a result, paragraph (d)(2)(ii)(A) incorrectly references paragraph (f)(1)(iii)(B) for installation of an equipment protective device (EPD); the correct reference is paragraph (f)(2)(i).

The FAA has determined that a correction to AD 2001-06-16 is necessary to revise an incorrect paragraph reference in paragraph (d)(2)(ii)(A) of AD 2001-06-16.

This document corrects the error and correctly adds the AD as an amendment to § 39.13 of the Federal Aviation Regulations (14 CFR 39.13).

The AD is reprinted in its entirety for the convenience of affected operators. The effective date of the AD remains May 7, 2001.

Since this action only corrects an incorrect paragraph reference, it has no adverse economic impact and imposes no additional burden on any person. Therefore, the FAA has determined that notice and public procedures are unnecessary.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-20-25, amendment 39-10791 (63 FR 50508, September 22, 1998), which is applicable to certain Boeing Model 747-100 series airplanes, was published in the Federal Register on November 9, 2000 (65 FR 67311). The action proposed to revise the applicability of the existing AD to add additional airplanes, require accomplishment of previously optional inspections and clarify those inspections, extend certain compliance times, and require additional work in certain areas.

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 commenter requests that the FAA revise the statement of unsafe condition in various places in the proposed AD. The statement appears as follows in the proposal: “The actions specified in this proposed AD are intended to detect and correct fatigue cracking of the outer chord * * *.” The commenter states that cracking has also been found in the skin, splice fittings, and bulkhead web, in addition to the outer chord. The FAA concurs with the commenter's request, and has changed this statement accordingly in various locations in this final rule.

One commenter requests that the FAA revise the proposed rule to refer to Boeing Alert Service Bulletin 747-53A2390, Revision 1; including Appendices A, B, C, and D; dated July 6, 2000; in addition to the original issue of the service bulletin; as an acceptable source of service information for paragraph (a)(2). As justification for its request, the commenter states that operators of Boeing Model 747-400 series airplanes may not have the original issue of the service bulletin available. The commenter also asks the FAA to revise Note 2 of the proposed AD to refer to Revision 1.

The FAA concurs with the intent of the commenter's request, but not with its justification because paragraph (a)(2) of this AD does not apply to Model 747-400 series airplanes. The FAA acknowledges, however, that Boeing Alert Service Bulletin 747-53A2390, Revision 1, has previously been approved as an alternative method of compliance for the actions in paragraphs (a)(1) and (a)(2) of this AD. To clarify this, the FAA has revised this final rule to add Note 2 after paragraph (a) of this AD, which states that Revision 1 has been approved as an alternative method of compliance for paragraphs (a)(1) and (a)(2) of this AD. (Subsequent notes have been renumbered accordingly.) Also, the FAA has revised Note 3 of this final rule (which was Note 2 of the proposed rule) to refer to Revision 1 as well as the original issue of the service bulletin.

One commenter requests that, for clarity, the FAA make the following changes to the proposed rule, for the following reasons:

• Revise the phrase “in accordance with the flight safety inspection program” to “in accordance with the after[-]modification inspection program” in paragraphs (d)(2), (e)(2), and (g)(2), because the inspections following the Plan “B” modification should not be confused with the flight safety inspections for Plan “A.”

• Revise the reference to Figures 6 and 7 in paragraph (e)(1) of the proposed rule to refer to only Figure 6, because Figure 7 includes a one-time inspection already required under paragraph (e).

• Revise the reference to “Figure 3 or Figure 8” in paragraph (g)(1) to read “Figures 3 and 8,” because Figures 3 and 8 are both necessary to accomplish inspections per Plan “A.”

• Revise the statement “Except as provided by paragraph (b) of this AD” in paragraph (i) of the proposed rule to read “Except as provided by paragraph (a)(1)(i) or (b) of this AD.” Paragraph (a)(1)(i) also provides for repairs in accordance with a method approved by the Manager, Seattle ACO; or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Company DER.

The FAA concurs with the commenter's requests, and has revised the appropriate paragraphs of this final rule accordingly.

The same commenter requests that the FAA revise paragraph (d)(1), paragraph (e), paragraph (e)(2), paragraph (g)(1), and paragraph (i) to refer to the original issue of Boeing Alert Service Bulletin 747-53A2390, dated July 31, 1997, in addition to Revision 1, as an acceptable source of service information for the actions in those paragraphs. The commenter states that operators that accomplished requirements in accordance with the original issue of the service bulletin should receive credit for these actions.

The FAA concurs with the intent of the commenter's request, and has added a new note, Note 6, to this AD to state that accomplishment of the actions specified in paragraphs (d)(1), (e), (e)(2), (g)(1), and (i) of this AD, in accordance with the original issue of Boeing Alert Service Bulletin 747-53A2390, is acceptable for compliance with those paragraphs.

One commenter requests that the FAA revise paragraph (i) to require that damage beyond the repair limits specified in the service bulletin be repaired according to a method approved by the FAA. The commenter states that operators must contact Boeing or the FAA to ensure that damage beyond the specified limits is repaired so that the repair meets the FAA type certificate, and to have the repaired structure evaluated for reduced inspection thresholds and repeat intervals. (Structure at fastener holes that are oversized beyond the limits in the service bulletin will have reduced fatigue life, and cracks in the area may grow rapidly.)

The FAA partially concurs with the commenter's request. The FAA considers that, as proposed, paragraph (b) of this AD would already require that operators repair any damage outside the limits specified in the service bulletin in accordance with a method approved by the FAA or with data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative who has been authorized by the Manager, Seattle Aircraft Certification Office, to make such findings. However, the FAA finds that explicitly stating this requirement in paragraph (i) may clarify the requirements of that paragraph. Thus, the FAA has revised paragraph (i) in this final rule accordingly.

One commenter requests that the FAA revise the compliance time in paragraph (f)(2) of the proposed AD from “Prior to the accumulation of 20,000 total flight cycles, or at the time of the next scheduled inspection of the lower bulkhead in accordance with paragraph (a)(2) of this AD, whichever occurs later,” to “20,000 total flight cycles, within 1,000 flight cycles of the effective date of the AD, or within 10,000 flight cycles of the previous inspections accomplished in accordance with paragraph (g)(1) of this AD, whichever occurs latest.” The commenter states that the proposed compliance time could cause airplanes to be grounded if an airplane has more than 20,000 total flight cycles but has not previously been inspected per paragraph (a)(2).

The FAA does not concur with the commenter's request. The compliance times in paragraph (f)(2) only apply if an inspection of the lower bulkhead has been done per paragraph (a)(2). If an airplane has not been inspected per paragraph (a)(2), then the compliance time in paragraph (f)(1), which includes a grace period of 1,000 flight cycles after the effective date of this AD, applies. No change is necessary in this regard.

Also in reference to paragraph (f)(2), the commenter notes that paragraph (a)(2) tells operators how, but not when, to inspect the bulkhead splice and bulkhead stringer interfaces. The FAA infers that the commenter is requesting that the FAA clarify the reference to paragraph (a)(2) in paragraph (f)(2) of this AD, and the FAA concurs with this request. Paragraph (a)(2)(ii) states that repetitive inspections are to be accomplished according to the flight safety inspection program, as specified in Figures 1 and 3 of the service bulletin. Figure 3 specifies the 10,000-flight-cycle repetitive interval. Therefore, the FAA finds that paragraph (f)(2) of this AD should refer to paragraph (a)(2)(ii) of this AD, and has revised that paragraph accordingly.

One commenter requests that the FAA revise the proposed rule to increase the compliance threshold for the inspections of the splice area (from 16,000 total flight cycles) and the stringer interface (from 20,000 total flight cycles). The commenter suggests a threshold of 25,000 total flight cycles. The commenter bases its request on inspections of its airplanes, many of which had more than 25,000 total flight cycles at the time of inspection. Though cracks were found, all were small enough to be removed by oversizing holes or installing bushing repairs.

The FAA does not concur with the commenter's request. Service information from the airplane manufacturer shows that large bulkhead repairs have been necessary on airplanes in Groups 1 through 3 with as few as 19,387 total flight cycles. Also, replacement of bulkhead cap fittings has been necessary on airplanes in Groups 4 through 18 with as few as 13,206 total flight cycles. These findings are consistent with the fact that the subject cracking is caused by fatigue, which can initiate cracks on airplanes at a wide range of flight cycles. In view of this information, the fact that the commenter found no large cracks on its airplanes, though the airplanes had more than 25,000 total flight cycles, does not justify an increase in the compliance threshold. The FAA finds that the proposed compliance times are necessary to ensure an adequate level of safety, and no change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraphs (c), (d), (d)(1), and (d)(2) of the proposed rule, to delete the references to Appendices C and D of the service bulletin. The commenter states that these paragraphs apply to airplanes in Groups 1 through 3, but Appendices C and D of the service bulletin only apply to airplanes in Groups 4 through 22. The commenter also asks the FAA to revise paragraph (e) to delete the reference to Appendix B of the service bulletin, because paragraph (e) applies to airplanes in Groups 4 through 22, but Appendix B of the service bulletin only applies to airplanes in Groups 1 through 3.

The FAA does not concur with the commenter's request. The references to the appendices with which the commenter is concerned are included in those paragraphs as a citation of the full service bulletin reference (Boeing Alert Service Bulletin 747-53A2390, Revision 1; including Appendices A, B, C, and D; dated July 6, 2000). If a service bulletin includes one or more appendices which are numbered separately from the main body of the service bulletin, the Office of the Federal Register requires the FAA to specify all appendices as part of every full citation of the service bulletin. No change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraph (e) of the proposed AD to give credit for inspections accomplished prior to the effective date of the AD. The commenter specifically requests that the FAA include a grace period of 6,000 flight cycles since the last inspection in accordance with paragraph (e)(1) of the AD. (The repetitive interval for the subject inspection is 6,000 flight cycles.)

The FAA concurs with the commenter's intent, but notes that credit for previously accomplished AD actions is always given by means of the phrase included in every AD, “Required as indicated, unless accomplished previously.” No change to the final rule is necessary in this regard.

One commenter requests that the FAA revise paragraphs (d)(2), (e)(2), and (g)(2) of the proposed rule to state, “* * * this paragraph postpones the repetitive inspection requirements * * *” rather than, “* * * this paragraph terminates the repetitive inspection requirements.” The commenter states that the actions in the service bulletin do not terminate inspections, but rather postpone inspections until 10,000, 16,000, or 20,000 flight cycles, as applicable, after modification.

The FAA does not concur with the commenter's request. The sentences in the paragraphs to which the commenter refers specify termination of the repetitive inspection requirements under Plan “A.” The paragraphs to which the commenter refers clearly state that inspections must still be accomplished in accordance with the after-modification inspection program. No change to the final rule is necessary in this regard.

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 previously described. 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 1,128 Model 747 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 259 airplanes of U.S. registry will be affected by this AD.

AD 98-20-25 applies to airplanes listed in Groups 1 through 3 of the service bulletin. The detailed visual inspection that is currently offered as one alternative for compliance with AD 98-20-25 takes approximately 16 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $960 per airplane, per inspection cycle.

For airplanes listed in Groups 1 through 3 in the service bulletin (34 U.S.-registered airplanes), the new detailed visual, ultrasonic, and open hole high frequency eddy current (HFEC) inspections of the upper bulkhead area that are required by this AD will take approximately 32 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of these inspections on U.S. operators is estimated to be $65,280, or $1,920 per airplane, per inspection cycle.

For airplanes listed in Groups 4 through 22 in the service bulletin (191 U.S.-registered airplanes), the new detailed visual, ultrasonic, and open hole HFEC inspections of the upper bulkhead area that are required by this AD will take approximately 22 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of these inspections on U.S. operators is estimated to be $252,120, or $1,320 per airplane, per inspection cycle.

For all airplanes listed in the applicability of this AD (259 U.S.-registered airplanes), the new detailed visual, ultrasonic, and open hole HFEC inspections of the lower bulkhead/stringer interface area that are required by this AD will take approximately 30 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of these required inspections on U.S. operators is estimated to be $466,200, or $1,800 per airplane, per inspection cycle.

The cost impact figures discussed above are 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 Boeing Model 737, 747, and 777 series airplanes was published in the Federal Register on December 22, 2000 (65 FR 80794). That action proposed to require replacement of the seat track fittings on all passenger seats with new, improved fittings.

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

A single commenter asks that the unsafe condition in the proposed rule which states, “To prevent unrestrained movement of the passenger seats during high forward deceleration of the airplane, which could result in injury to the passengers or crew members during an emergency landing,” be changed to read, “To verify that during seat installation no over-torque on seat track fitting shear bolts occurred.” The commenter also asks that paragraph (a) of the proposed rule be changed to read, “Within 1 month after the effective date of this AD: Inspect all the seat track fittings on all the passenger seats as specified in the applicable component maintenance manual under the section titled, ‘Troubleshooting,’ following the troubleshooting procedure therein.”

The commenter states that if the old fitting is properly installed (i.e., the maximum allowable torque value is not exceeded, and the shear plunger is correctly engaged), no risk of unrestrained movement of the passenger seat under any circumstances, including high forward deceleration, can occur. The commenter notes that this has been demonstrated during the certification process of the seat, and found acceptable by all involved airworthiness authorities. To date there is no evidence that such an occurrence is even possible, provided that the installation specifications of the seat manufacturer are fully accomplished. The commenter also states that if the new improved fitting is used, but the maximum allowable torque value is exceeded, then an unrestrained movement of the passenger seat is possible exactly as with the old fitting in the same condition. The commenter concludes that issuance of an airworthiness directive requiring the replacement of old fittings with new, improved fittings having a higher maximum torque value only, is ineffective to prevent unrestrained seat movement. Additionally, the origin of the eventual safety problem resides in the application on the shear bolt of high torque value, exceeding the maximum allowable torque specified by the seat manufacturer.

The FAA does not concur. As stated in the proposed rule, the manufacturer reported that the shear plunger screws of certain seat track fittings broke during installation. Analysis of the broken screws revealed that various modifications had weakened the shear plunger screws. Further analysis revealed that high torque during seat installation resulted in broken shear plunger screws and subsequent disengagement of the shear plunger from the seat track. Additionally, the manufacturer found that the threads used to attach the shear plunger screws to the seat track were filled with coating that was used on the exterior of the screws, which increases the torque required to install the screw. This information indicates that the torque required to install the shear plunger screws is very close to the strength of the screw, and as the seats are moved for maintenance or interior reconfigurations, breaking of the shear plunger screws is to be expected. The new, improved design of the seat track fitting corrects the deficiencies in the existing design, and is necessary to correct the unsafe condition specified in this final rule. Therefore, no change to the final rule is necessary.

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 as proposed.

There are approximately 46 Model 737, 747, and 777 series airplanes of the affected design in the worldwide fleet.

For Model 737 series airplanes (2 U.S.-registered airplanes): It will take approximately 10 work hours per airplane to accomplish the replacement, at an average labor rate of $60 per work hour. Required parts will cost approximately $15,100 per airplane. Based on these figures, the cost impact of the replacement required by this AD on U.S. operators is estimated to be $31,400, or $15,700 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed 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.

Currently, there are no affected Model 747 series airplanes on the U.S. Register. However, should an affected airplane be imported and placed on the U.S. Register in the future, it requires approximately 29 work hours to accomplish the replacement, at an average labor rate of $60 per work hour. Required parts will cost approximately $43,000. Based on these figures, the cost impact of the replacement required by this AD will be $44,740 per airplane.

Currently, there are no affected Model 777 series airplanes on the U.S. Register. However, should an affected airplane be imported and placed on the U.S. Register in the future, it requires approximately 24 work hours to accomplish the replacement, at an average labor rate of $60 per work hour. Required parts will cost approximately $36,400. Based on these figures, the cost impact of the replacement required by this AD will be $37,840 per airplane.

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) by superseding AD 99-18-16, amendment 39-11282 (64 FR 47653, September 1, 1999), applicable to certain Boeing Model 747-400, 757-200, 767-200, and 767-300 series airplanes, was published in the Federal Register on June 15, 2000 (65 FR 37494). That action proposed to continue to require the actions specified in AD 99-18-16, and to add a terminating action for the repetitive checks and tests. That action also proposed to make those requirements applicable to other airplanes on which the defective power supplies may be installed, eliminate the repetitive tests for certain airplanes, and increase the interval for the repetitive tests for certain other airplanes. Additionally, that action also proposed to require replacement of any subject power supply in the WEU or MAWEA with a new, modified, or serviceable power supply. That action was prompted by a report of a MAWEA power supply failure due to inadequate over-voltage protection.

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 commenter supports the actions specified by the proposed AD. Four other commenters state that they are either not affected by the proposed AD or are in compliance with the proposed actions.

One commenter states that the FAA should determine the number of power supply modules, part number (P/N) 285T0035-201, currently installed on airplanes. If the subject power supply module is found, the FAA should require a fleet check for part numbers and serial numbers before requiring fleetwide preflight checks. If the manufacturer of the subject part (Boeing) could identify which serial numbers were produced and identify the units that have been modified by July 2000, there may be no need to issue an AD. The FAA infers that the commenter is requesting that the proposed AD be withdrawn.

The FAA does not concur that the proposed AD should be withdrawn. The applicability of this AD limits the requirements to only certain airplanes on which the affected P/N is installed. Airplanes not included in the applicability are not subject to preflight checks or the requirements of this AD. Issuance of this AD is necessary to require U.S. operators of airplanes with the affected P/N installed to accomplish the required actions.

One commenter requests that the FAA clarify the terminating action required by the proposed AD. The commenter states that the intent of the proposed AD is to replace all power supplies, P/N 285T0035-201, found on certain Model 747, 757, and 767 series airplanes and those power supplies in stock. After such replacement, no further repetitive checks are required. However, the proposed AD does not provide clear direction to the terminating action. Paragraphs (a) and (b) of the proposed AD require “test and replacement” action per paragraph (c) or (f). If the action in paragraph (c) or (f) is terminated, operators are not required to do the action required by paragraph (d) or (e), which specify repetitive checks (for Model 747-400 and -400F series airplanes not listed in paragraph (a)) and repetitive checks and functional tests (for Model 757 and 767 series airplanes not listed in paragraph (b)). The operator states that, even though it has replaced the subject power supplies, the proposed AD still requires the repetitive checks (as specified in paragraph (d) of the proposed AD), and the repetitive checks and functional tests (as specified in paragraph (e) of the proposed AD). This creates an unintended burden on operators.

The FAA clarifies that the actions required by paragraphs (a), (b), and (c) of this AD in the section, “Partial Restatement of Requirements of AD 99-18-16,” are included for operators that have not already replaced the power supplies. For those operators, the checks and functional tests, as well as the corrective actions, continue to be required by this new AD. The replacement action was not required by AD 99-18-16. However, this new AD requires replacement of any subject power supplies within 1 year after the effective date of this AD, as the terminating action. Paragraphs (c)(1), (c)(2), and (c)(3) of this AD, clearly state that replacement of the subject power supplies constitutes terminating action for the requirements of this AD. In addition, we point out that the actions required by paragraphs (d) and (e) of this AD only apply to airplanes not subject to the requirements of paragraphs (a) and (b). Paragraphs (d) and (e) both specify that replacement action terminates the repetitive checks and tests specified by this AD. The FAA has revised paragraph (f) of this final rule to clarify that such replacement terminates “the requirements of this AD,” rather than “the repetitive inspection requirements of this AD.”

One commenter requests an inspection of the power supply module to identify the P/N installed at the next “A” check or 45 days (after the effective date of this AD), whichever occurs earlier, and repetitive inspections if subject P/N 285T0035-201 is found. The commenter contends that the first action in paragraphs (d) and (e) of the proposed AD is to check the status page of the EICAS for any MAWEA or WEU failures, which assumes that the subject P/N is installed. However, the FAA should clarify those paragraphs to specify that operators first must determine if a subject P/N is installed at the next “A” check or 45 days (after the effective date of this AD), whichever occurs first. If a subject P/N is found, then the proposed AD should require repetitive checks (as specified in paragraphs (d) and (e) of the proposed AD). The commenter adds that there is no assurance that the subject P/N has not been subsequently installed on an airplane that was modified per AD 99-18-16.

The FAA does not concur with the commenter's request to require an additional inspection to determine if a subject P/N is installed. The applicability statement and certain paragraphs of this AD limit the required actions to only certain airplanes equipped with either a WEU or MAWEA power supply having P/N 28T0035-201. Some operators should be able to review their maintenance log books to determine if the subject P/N has been replaced. Therefore, it is not necessary to add an inspection in paragraphs (d) and (e) of this AD to determine if a subject power supply is installed.

Also, the repetitive checks required by paragraphs (d) and (e) of this AD are limited to only certain airplanes equipped with either a WEU or MAWEA power supply having P/N 285T0035-201, other than those airplanes identified in paragraph (a) or (b) of this AD. We have revised paragraphs (d) and (e) of this AD accordingly to clarify any confusion.

We do not agree that operators may have inadvertently installed the subject P/N on a previously modified airplane. We point out that, for airplanes subject to AD 99-18-16, paragraph (g) of that AD specifies that no person shall install a WEU or MAWEA power supply having P/N 285T0035-201 on any airplane as of the effective date of that AD, as specified in paragraph (g)(1) of this AD. Therefore, no change to this AD is necessary in this regard.

Two commenters request changing a paragraph reference in paragraphs (d)(1) and (e)(1) of the proposed AD. The commenters state that the correct paragraph reference for the terminating action required by the proposed AD is paragraph (f) instead of paragraph (e). The FAA concurs with this request and has changed the final rule accordingly.

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 previously described. 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 1,592 Model 747-400, 747-400F, 757-200, 757-200CB, 757-200PF, 767-200, 767-300, and 767-300F series airplanes of the affected design in the worldwide fleet. The FAA estimates that 802 airplanes of U.S. registry will be affected by this AD.

The repetitive checks and tests required by AD 99-18-16 are currently applicable to approximately 33 U.S.-registered airplanes. The repetitive checks and tests take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required checks and tests on U.S. operators is estimated to be $1,980, or $60 per airplane, per check/test cycle. Because this AD eliminates the currently required repetitive tests for certain airplanes, and increases the repetitive interval for the tests for certain other airplanes, this AD reduces the costs to operators currently subject to AD 99-18-16.

The repetitive checks and tests in this new action are applicable to approximately 769 additional airplanes. Based on the figures discussed above, the new costs to U.S. operators for the repetitive checks and tests imposed by this AD are estimated to be $46,140, or $60 per airplane, per check/test cycle.

For all airplanes subject to this AD, the new replacement action required by this AD takes approximately 3 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts cost approximately $6,424 per airplane. Based on these figures, the cost impact of the replacement required by this AD on U.S. operators is estimated to be $5,296,408, or $6,604 per airplane.

The cost impact figures discussed above are 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 Boeing Model 737, 757, and 767 series airplanes was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on June 21, 2000 (65 FR 38450). That action proposed to require repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning; replacement with new valves, if necessary; and eventual replacement of certain existing valves with new valves, which terminates the repetitive inspections.

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 commenter concurred with the original notice of proposed rulemaking (NPRM), and that commenter submitted no additional comment to the supplemental NPRM.

Several commenters request that the FAA clarify the language in the original NPRM and supplemental NPRM to clarify what valves on the airplane are subject to the proposed AD. The commenters point out that the referenced service bulletins apply only to valves in “sensitive system” applications (hereinafter referred to as “sensitive” applications). However, the language in the NPRM and supplemental NPRM does not clarify whether only valves with the subject part numbers (P/N) in “sensitive” applications are subject to the requirements of the proposed AD, or whether ALL valves with the subject P/N's installed on the airplane are subject to the proposed AD, regardless of whether the valves are installed in “sensitive” or “non-sensitive” applications.

The FAA concurs with the commenters' request for clarification. This AD is intended to apply only to the valves in locations listed in the referenced service bulletins—that is, valves in “sensitive” applications. The FAA has revised paragraphs (a) and (b) of this AD accordingly and added a new note, Note 1, after the applicability statement to clarify this issue. (Subsequent notes have also been reordered.)

Operators should note that, while the airplane manufacturer will issue new service bulletins with instructions for replacing valves in “non-sensitive” applications on the affected airplanes, at this time, the FAA does not plan to mandate replacing these valves.

Several operators request that the FAA revise the proposed AD to reference new service bulletins issued by Boeing.

The FAA concurs with the commenters' request and—since the issuance of the supplemental NPRM—has reviewed and approved the following 10 new service bulletins:

• Boeing Alert Service Bulletin 737-29A1073, Revision 3, including Appendices A and B, dated December 2, 1999: This service bulletin revises Boeing Service Bulletin 737-29A1073, Revision 2, dated July 1, 1999, which was referenced as an appropriate source of service information in the supplemental NPRM. Revision 3 describes procedures for repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning on certain Boeing Model 737-100, -200, -300, -400, and -500 series airplanes. The procedures in this bulletin are essentially similar to those in Revision 2; however, this service bulletin removes all Boeing Model 737-600, 737-700, and 737-800 series airplanes from the effectivity listing. (Boeing Model 737-600, -700, and -800 series airplanes have been included in a new service bulletin, which is described below.) This service bulletin also references a new service bulletin, described below, that describes replacement of the subject valves with new, improved valves, which ends the need for the repetitive operational checks.

• Boeing Alert Service Bulletin 737-29A1081, including Appendices A and B, dated December 2, 1999: This service bulletin describes procedures for repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning on certain Boeing Model 737-600, 737-700, and 737-800 series airplanes. These procedures are essentially the same as those described in Boeing Alert Service Bulletin 737-29A1073, Revision 2, for these airplanes. This service bulletin also references a new service bulletin, described below, that describes replacement of the subject valves with new, improved valves, which ends the need for the repetitive operational checks.

• Boeing Alert Service Bulletin 757-29A0048, Revision 3, including Appendices A and B, dated December 2, 1999: This service bulletin revises Boeing Service Bulletin 757-29A0048, Revision 2, dated July 1, 1999, which was referenced as an appropriate source of service information in the supplemental NPRM. Revision 3 describes procedures for repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning on certain Boeing Model 757 series airplanes. The procedures in this service bulletin are essentially similar to those in Revision 2; however, this service bulletin removes all Boeing Model 757-300 series airplanes from the effectivity listing. (Boeing Model 757-300 series airplanes have been included in a new service bulletin, which is described below.) This service bulletin also references a new service bulletin, described below, that describes replacement of the subject valves with new, improved valves, which ends the need for the repetitive operational checks.

• Boeing Alert Service Bulletin 757-29A0051, including Appendices A and B, dated December 2, 1999: This service bulletin describes procedures for repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning on certain Boeing Model 757-300 series airplanes. These procedures are essentially similar to those described in Boeing Alert Service Bulletin 757-29A0048, Revision 2, for these airplanes. This service bulletin also references a new service bulletin, described below, that describes replacement of the subject valves with new, improved valves, which ends the need for the repetitive operational checks.

• Boeing Service Bulletin 767-29A0083, Revision 4, including Appendix A, dated September 28, 2000: This service bulletin revises Boeing Service Bulletin 767-29A0083, Revision 2, dated July 15, 1999, which was referenced as an appropriate source of service information in the supplemental NPRM. This service bulletin describes procedures for repetitive operational checks of certain motor-operated hydraulic shutoff valves to detect malfunctioning on certain Boeing Model 767 series airplanes. The procedures in this service bulletin are essentially similar to those in Revision 2. However, this service bulletin also corrects certain instructions for the functional test of two of the motor-operated hydraulic shutoff valves. The service bulletin states that the functional tests in previous revisions of the service bulletin, including Revision 2, could not be completed without the revised instructions contained in Revision 4.

• Boeing Alert Service Bulletin 737-29A1078, dated December 7, 2000: This service bulletin describes procedures for replacement of Circle Seal Controls valves in “sensitive” applications on certain Boeing Model 737-100, -200, -300, -400, and -500 series airplanes, with certain new Whittaker Controls valves or new, improved Circle Seal Controls valves. Such replacement terminates the repetitive operational checks described in Boeing Alert Service Bulletin 737-29A1073, Revision 3.

• Boeing Alert Service Bulletin 737-29A1082, dated December 7, 2000: This service bulletin describes procedures for replacement of Circle Seal Controls valves in “sensitive” applications on certain Boeing Model 737-600, -700, and -800 series airplanes, with certain new Whittaker Controls valves or new, improved Circle Seal Controls valves. Such replacement terminates the repetitive operational checks described in Boeing Alert Service Bulletin 737-29A1081.

• Boeing Alert Service Bulletin 757-29A0049, dated December 7, 2000: This service bulletin describes procedures for replacement of Circle Seal Controls valves in “sensitive” applications on certain Boeing Model 757-200 series airplanes, with certain new Whittaker Controls valves or new, improved Circle Seal Controls valves. Such replacement terminates the repetitive operational checks described in Boeing Alert Service Bulletin 757-29A0048, Revision 3.

• Boeing Alert Service Bulletin 757-29A0052, dated December 7, 2000: This service bulletin describes procedures for replacement of Circle Seal Controls valves in “sensitive” applications on certain Boeing Model 757-300 series airplanes, with certain new Whittaker Controls valves or new, improved Circle Seal Controls valves. Such replacement terminates the repetitive operational checks described in Boeing Alert Service Bulletin 757-29A0051.

• Boeing Alert Service Bulletin 767-29A0090, dated December 7, 2000: This service bulletin describes procedures for replacement of Circle Seal Controls valves in “sensitive” applications on certain Boeing Model 767 series airplanes, with certain new Whittaker Controls valves or new, improved Circle Seal Controls valves. Such replacement terminates the repetitive operational checks described in Boeing Service Bulletin 767-29A0083, Revision 4.

In view of the approval of these service bulletins by the FAA, we have revised paragraph (a) of this AD to specify Boeing Service Bulletins 737-29A1073, Revision 3 (for Model 737- 100, -200, -300, -400, and -500 series airplanes), 737-29A1081 (for Model 737-600, -700, and “800 series airplanes), 757-29A0048, Revision 3 (for Model 757-200 series airplanes), 757-29A0051 (for Model 757-300 series airplanes), and 767-29A0083, Revision 4 (for Model 767 series airplanes); as applicable; as appropriate sources of service information for the requirements of that paragraph. The FAA has revised paragraph (b) of this AD to specify Boeing Alert Service Bulletins 737-29A1078 (for Model 737-100, -200, -300, -400, and -500 series airplanes), 737-29A1082 (for Model 737-600, -700, and -800 series airplanes), 757-29A0049 (for Model 757-200 series airplanes), 757-29A0052 (for Model 757-300 series airplanes), and 767-29A0090 (for Model 767 series airplanes), as appropriate sources of service information for the requirements of that paragraph.

In addition, the FAA has provided for airplanes on which the requirements of this AD have been accomplished before the effective date of this AD, by adding two new notes, Notes 3 and 4, which specify that operational checks and valve replacements done before the effective date of this AD per Boeing Alert Service Bulletins 737-29A1073, Revision 2, or 757-29A0048, Revision 2, both dated July 1, 1999; or 767-29A0083, Revision 2, dated July 15, 1999; as applicable; are acceptable for compliance with paragraphs (a) and (b) of this AD.

Also, the applicability statement of this final rule has been revised to specify airplanes listed in Boeing Service Bulletins 737-29A1073, Revision 3, 737-29A1081, 757-29A0048, Revision 3, 757-29A0051, and 767-29A0083, Revision 4. The FAA has determined that this change does not add any new airplanes to the applicability statement which were not included in the applicability statement of the proposed rule.

Several commenters request that the FAA revise paragraph (a)(1) of the supplemental NPRM to allow replacement of malfunctioning Circle Seal Controls valves having P/N's S270T010-1 through -9, with new or serviceable Circle Seal Controls valves having P/N's S270T010-1 through -9. Paragraph (a)(1) of the supplemental NPRM requires replacement of a malfunctioning valve with a new Whittaker Controls valve, and paragraph (c) of the supplemental NPRM prohibits installation after the effective date of this AD of “any part identified in the ‘Existing Part Number’ column (including parts marked with the suffix “R” after the serial number), of Paragraph 2.E.” of the applicable alert service bulletin. Parts listed in the “Existing Part Number” column are Circle Seal Controls valves having P/N's S270T010-1 through -9. The commenters state that prohibiting installation any new or serviceable valves with P/N's S270T010-1 through -9 imposes an undue burden on operators. Commenters are also concerned that airplanes needing replacement valves could be grounded if Whittaker Controls is unable to produce a sufficient amount of replacement parts.

The FAA concurs with the commenters' request to allow installation of serviceable parts. The FAA has revised paragraph (a)(2) of this AD to allow replacement of a malfunctioning valve with a new or serviceable replacement valve manufactured by Circle Seal Controls or Whittaker Controls. A valve replaced with a new or serviceable Circle Seal Controls valve having a P/N S270T010-1 through -9 will continue to be subject to repetitive operational checks per paragraph (a) of this AD, until the terminating action is accomplished per paragraph (b). Replacement of a valve with a new or serviceable Whittaker Controls valve or a new or serviceable Circle Seal Controls valve with P/N S270T010-10, -11, -12, -13, -14, or -15; as applicable; terminates the repetitive inspections for the replaced valve. Relevant to this change to paragraph (a)(1) of this AD, it is no longer necessary to include paragraph (c) of the supplemental NPRM in this AD. [Installation of a Circle Seal Controls valve having a P/N S270T010-1 through -9 is prohibited after 3 years after the effective date of this AD by virtue of the terminating action required by paragraph (b) of this AD.]

Two commenters request that the FAA clarify the requirements of paragraph (a)(1) of the supplemental NPRM. The commenters point out that paragraph (a)(1) of the supplemental NPRM requires replacement of any malfunctioning Circle Seal Controls valve with a new Whittaker Controls valve before further flight. However, that paragraph goes on to require repeating the operational check required by paragraph (a). The commenters point out that paragraph (b) of the supplemental NPRM states that replacement of Circle Seal Controls valves with new Whittaker Controls valves constitutes terminating action for the repetitive inspections required by paragraph (a) of this AD. Therefore, replacement parts installed per paragraph (a)(1) of this AD should not be subject to the repetitive operational checks.

The FAA concurs with the commenters' rationale. Replacement of all existing Circle Seal Controls valves with new Whittaker Controls valves does constitute terminating action for the requirements of paragraph (a) of this AD for the replaced valve. However, as stated previously, the FAA has revised this final rule to allow replacement of existing Circle Seal Controls valves with serviceable valves having certain part numbers. Accordingly, paragraph (a)(1) has been revised in this final rule, and paragraph (c) of the supplemental NPRM has not been included in this final rule. No further change to the final rule is needed in this regard.

Several commenters request that the FAA revise the supplemental NPRM to allow use of certain valves manufactured by Circle Seal Controls, Inc., as terminating action for the repetitive operational checks in paragraph (a) of the proposed AD. The supplemental NPRM only allowed replacement of any Circle Seal Controls valve with a new Whittaker Controls valve as terminating action for the repetitive operational checks. (The original NPRM had referenced replacement with Circle Seal Controls valves with part numbers (P/N) S270T010-10, -11, and -12, as terminating action. However, as explained in the supplemental NPRM, the FAA reviewed information regarding the failure rate of the valves and determined that the valves were not an adequate replacement.) The commenters' rationale for their requests includes the following:

• Boeing has found that initial failures of Circle Seal Controls valves with P/N's S270T010-10, -11, and -12 were due to improper rework rather than design flaws. Thus, Boeing now considers these Circle Seal Controls valves adequate for terminating action. Other commenters state that these Circle Seal Controls valves provide an equivalent level of safety to that provided by the Whittaker Controls valves.

• Some operators are concerned about Whittaker Controls' ability to produce an adequate supply of replacement parts within the three-year compliance time for the replacement required by this AD.

• Some operators point out that the supplemental NPRM does not require repetitive operational checks of Circle Seal Controls valves with P/N's S270T010-10, -11, and -12; therefore, these valves should be acceptable for terminating action.

The FAA concurs with the commenters' request to revise the final rule to allow use of certain Circle Seal Controls valves as terminating action for this AD's repetitive operational checks. The FAA finds that replacement of existing Circle Seal Controls valves with Circle Seal Controls valves with P/N S270T010-10, -11, -12, -13, -14, or -15; or with Whittaker Controls valves; is acceptable for doing the terminating action in paragraph (b) of this AD. Paragraph (b) of this AD has been revised accordingly.

While replacement with Circle Seal Controls valves with P/Ns S270T010-10, -11, and -12 is acceptable as terminating action, the FAA points out that these valves are not currently being manufactured by Circle Seal Controls. That company is only manufacturing P/Ns S270T010-13, -14, and -15 valves.

One commenter requests that the FAA revise the “Discussion” section in the original NPRM and one sentence in the “Summary” section to more accurately explain what prompted the proposed AD. The sentence in the “Summary” explains that the proposal “was prompted by reports that the motor switch contacts on certain hydraulic shutoff valves were mis-aligned, causing subsequent malfunction of those valves.” The commenter states that this statement could be misleading and requests that the FAA use a more general statement.

The FAA concurs with the commenter's request, and has revised the affected sentence in the summary of this final rule to state that this AD is prompted by reports that “various intermittent limit switch problems have caused valve failures.” (As the “Discussion” section is not restated in this final rule, no change is necessary in that regard.)

One commenter requests that the FAA NOT revise the supplemental NPRM to allow installation of Circle Seal Controls valves to be terminating action for the repetitive operational checks in this AD. The commenter states that Circle Seal Controls, Inc., has repeatedly failed to design and manufacture reliable valves. The commenter points out that each new design has met all of the airplane manufacturer's design criteria, passed all the appropriate tests, and been approved by the FAA. However, after each approval, the valves failed to function. The commenter also questions whether the FAA made an error in the applicability of the supplemental NPRM by making the AD apply only to Circle Seal Controls valves having P/N S270T010-1 through -9. The commenter requests that the AD also apply to Circle Seal Controls valves having P/N S270T010-10 through -12.

The FAA does not concur with the commenter's requests. Information provided by the manufacturer regarding the failure rate of Circle Seal Controls valves having P/N S270T010-10 through -12 resulted in the FAA removing these parts from the list of replacement parts acceptable for terminating action in the supplemental NPRM. However, since the issuance of the supplemental NPRM, the FAA has determined that the failures in Circle Seal Controls valves having P/N S270T010-10 through -12 were due to manufacturing errors, not design flaws. Also, further refinements in the design of P/N S270T010-13 through -15 have focused on improving the ease of manufacture and assembly of the valves. Thus, as stated previously, the FAA is revising this final rule to allow installation of either new Whittaker Controls valves or new Circle Seal Controls parts having P/N S270T010-10 through -15 as terminating action for the requirements of this AD. The FAA finds that these parts will adequately ensure the continued safety of the airplane fleet. No further change to the final rule is necessary in this regard.

One of the commenters that requested clarification on which valves are subject to the proposed AD also requests that the FAA require replacement of ALL valves of the subject part numbers on the affected airplanes, not just those installed in locations listed in the service bulletins. The commenter's rationale is that, if the AD applies only to valves installed in “sensitive” applications, it will result in a “configuration control nightmare” for operators, with some valves being acceptable for installation in some applications on the affected airplanes, but not in other applications. The commenter's point is that valves may not be interchangeable from one location to another. Thus, operators will be forced to track the manufacturer of every valve and create customized maintenance instructions to ensure that correct valves are installed in the correct locations on the airplane.

Though the FAA acknowledges that operators will have to track the location of each valve to ensure that only the correct parts are installed in the locations identified in the referenced service bulletins, the FAA does not concur that it is necessary to require replacement of all valves of the affected part numbers, regardless of location, on the subject airplanes. Requiring replacement of all valves in all locations, “sensitive” and “non-sensitive,” would place an undue burden on affected operators and may call into question the availability of replacement parts for the three-year compliance time. No change to the final rule is necessary in this regard.

Two commenters request that the FAA increase the threshold and repetitive interval for the operational checks in paragraph (a) of the proposed AD. One commenter requests that the interval be increased from 6 months to 456 days; the other commenter requests an increase to 1 year. The first commenter states that the frequency of operational checks associated with the six-month interval may increase the likelihood of failure of the valves. The commenter bases its comment on the fact that, except for testing, the valves would normally only be operated during an emergency situation, and the six-month interval would add unnecessary cycles and may eventually contribute to an early failure of the valves. The other commenter states that there is no technical justification for the six-month threshold and interval because proper operation of the valves cannot be guaranteed no matter how frequent the operational checks. The commenters both state that an increased threshold and repetitive interval will still be adequate to ensure safety of flight.

The FAA does not concur with the commenters' requests. While the second commenter is correct that an operational check only guarantees the functionality of the valve for that one cycle and the valve could fail the next time it is cycled, the FAA finds that the operational check may be sufficient to detect valves that are likely to fail. In addition, the repetitive inspection interval of six months will ensure that a failed valve will be detected in a timely manner. No change to the final rule is necessary in this regard.

Several commenters request that the FAA revise the proposed rule to extend the three-year compliance time for the replacement in paragraph (b) of the proposed AD. Certain commenters state that three years is not enough time for operators to replace nearly 5,000 valves in the affected airplane fleet. One commenter suggests a compliance time of four years; another suggests four and a half years. Certain commenters express concern that the parts manufacturers may not be able to produce an adequate supply of parts for replacement of affected valves on the entire affected worldwide fleet within the three-year compliance time. The commenters state that repetitive operational checks at six-month intervals, as required by paragraph (a) of this AD, should provide an adequate level of safety until valves can be replaced.

The FAA does not concur with the commenters' request for an extension of the compliance time for paragraph (b) of this AD. The compliance time for the replacement of existing Circle Seal Controls valves was extended from two years to three years in the supplemental NPRM. The FAA finds that three years is the maximum time that affected airplanes may be allowed to continue to operate with the older-design Circle Seal Controls valves installed. Based on commitments by Whittaker Controls, the FAA finds that an adequate supply of replacement parts will be available within the three-year compliance time for replacement the subject valves on affected airplanes. No change to the final rule is necessary in this regard.

Two commenters ask the FAA to revise the cost impact information presented in the proposed rule. One of the commenters states that, for the operational check on Model 757 series airplanes, it finds 12 work hours to be a more accurate estimate than the 3 hours stated in the proposal. The other commenter states that the FAA has “grossly underestimated” the costs associated with this AD: the estimated inspection cost is for a single operational check, but the check will be required twice per year until accomplishment of the terminating action. The second commenter also states that if the cost estimate is intended to reflect the cost of replacing all Circle Seal Controls valves (i.e., in “sensitive” and “non-sensitive” applications), the FAA's underestimation is worse.

The FAA does not concur with the commenters' request to revise the cost impact information. The cost impact information describes only the “direct” costs of the specific actions required by this AD. The number of work hours necessary to accomplish the required actions is based on the manufacturer's estimate provided in the service bulletin, excluding the time necessary to gain access and close up. The estimate represents the time necessary to perform only the actions actually required by this AD. The FAA recognizes that, in accomplishing the requirements of any AD, operators may incur “incidental” costs in addition to the “direct” costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. Because incidental costs may vary significantly from operator to operator, they are almost impossible to calculate.

With regard to the commenter's observation that the cost impact estimate is only for a single operational check, the FAA points out that the cost estimate states that the cost is “per operational check.”

With regard to the commenter's observation about replacement of all Circle Seal Controls valves versus replacement of all valves specified in the service bulletin: as stated previously, this AD only requires replacement of the valves stated in the applicable service bulletin.

No change to the final rule is necessary in this regard.

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 previously described. 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 3,029 Boeing Model 737 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 1,234 airplanes of U.S. registry will be affected by this AD, and that it will take approximately 2 work hours per airplane to accomplish the required operational check, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this requirement on U.S. operators of these airplanes is estimated to be $148,080, or $120 per airplane, per operational check.

There are approximately 802 Boeing Model 757 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 558 airplanes of U.S. registry will be affected by this AD, and that it will take approximately 3 work hours per airplane to accomplish the required operational check, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this requirement on U.S. operators of these airplanes is estimated to be $100,440, or $180 per airplane, per operational check.

There are approximately 701 Boeing Model 767 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 280 airplanes of U.S. registry will be affected by this AD, and that it will take approximately 4 work hours per airplane to accomplish the required operational check, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this requirement on U.S. operators of these airplanes is estimated to be $67,200, or $240 per airplane, per operational check.

For all airplanes, it will take approximately 5 work hours per valve to accomplish the replacement required by this AD, at an average labor rate of $60 per work hour. Required parts and hydraulic fluid will cost approximately $4,316 per airplane. Based on these figures, the cost impact of the valve replacements required by this AD on U.S. operators is estimated to be $4,616 per airplane, per valve replacement. This AD will require eventual replacement of approximately 5,000 valves.

The cost impact figures discussed above are 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 .

On April 24, 2001, the FAA issued emergency AD 2001-09-51, which is applicable to certain Boeing Model 737-600, -700, -700C, and -800 series airplanes.

That action was prompted by reports indicating that, during accomplishment of actions required by AD 2001-04-08, amendment 39-12127 (66 FR 13229, March 5, 2001), operators found problems with the elevator tab control rods on certain Boeing Model 737-700 and -800 series airplanes. One operator found jam nuts that had been installed improperly. Two other operators reported damage that was attributed to inadequately torqued jam nuts. The control rod jam nuts may not have been torqued properly when the control rod length was rigged at Boeing prior to delivery of the airplanes.

Improperly torqued jam nuts on the elevator tab control rods could result in damage to the tab control rod. If both tab control rods are damaged, excessive freeplay in the tab control mechanism can occur, which could result in elevator tab flutter. This condition, if not corrected, could result in loss of controllability of the airplane.

The elevator tab control rods on Model 737-600 and -700C series airplanes are identical to those on the affected Model 737-700 and -800 series airplanes. Therefore, those Model 737-600 and -700C series airplanes may be subject to the same unsafe condition revealed on Model 737-700 and -800 series airplanes.

The FAA has reviewed and approved Boeing Alert Service Bulletin 737-27A1245, dated April 23, 2001, which describes procedures for inspecting the small jam nut on the elevator tab control rods to detect inspection putty and to determine its condition; a torque check of the small and large jam nuts on the tab control rod, if necessary; and corrective actions (including performing a detailed visual inspection of the threads on the rod end bearing for wear, measuring the diameter of the threads on the rod end bearing, replacing the rod end bearing and the threaded adjustment bushing, torquing the jam nuts, and applying inspection putty), as applicable.

For any control rod jam nut on which the putty is found and is intact, the alert service bulletin also describes procedures for a one-time inspection for torque of the small and large jam nuts on the tab control rods; and corrective actions (including performing a detailed visual inspection of the threads on the rod end bearing for wear, measuring the diameter of the threads on the rod end bearing, replacing the rod end bearing and the threaded adjustment bushing, torquing the jam nuts, and applying inspection putty), as applicable.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of this same type design, this airworthiness directive is issued to require the actions specified in the alert service bulletin described previously. The actions are required to be accomplished in accordance with the alert service bulletin described previously.

This AD also requires that operators report both positive and negative results of inspections to Boeing.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual notices issued on April 24, 2001, to all known U.S. owners and operators of Boeing Model 737-600, -700, -700C, and -800 series airplanes. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

For clarification, the FAA notes that, while the alert service bulletin does not specify that Model 737-700C series airplanes are subject to the actions in the alert service bulletin, the list of affected line numbers in the applicability of this AD includes the line numbers of certain Model 737-700C series airplanes.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-126-AD.” The postcard will be date stamped and returned to the commenter.

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.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, recently notified the FAA that an unsafe condition may exist on certain Airbus Model A330 and A340 series airplanes. The DGAC advises that four cases of transfer tube disconnection from the ball nut of the trimmable horizontal stabilizer actuator (THSA) have been detected during greasing of in-service Model A330 and A340 series airplanes. The cause was found to be water entering the ball nut of the THSA, resulting in jamming of the ball transfer path when the water froze. There are three independent circuits of balls. The loss of one or two circuits does not impact the THSA operation, as it continues to operate on the remaining circuits. If three circuits are lost, then the THSA operates on the fail-safe nut. Due to the high friction between the fail-safe nut and the screw, THSA operation will be inefficient and it will lock after a few movements. This degraded operation is not detectable by the flight crew as long as the THSA is not locked and could damage the screw and the fail-safe nut. Jamming of the ball transfer paths, if not corrected, could result in degraded operation of the THSA and consequent reduced controllability of the airplane.

Airbus has issued All Operator Telexes (AOT) A330-27A3088 and A340-27A4093, both dated April 5, 2001, which describe procedures for repetitive detailed visual inspections of the ball nut in the area of the transfer tubes for, among other things, evidence of ball migration from the ball nut; distortion of the collar or transfer tubes; or disconnection of the transfer tubes from the ball nut; and replacement of the THSA, if necessary. The DGAC classified these AOTs as mandatory and issued French airworthiness directives 2001-141(B) and 2001-140(B), both dated April 18, 2001, in order to assure the continued airworthiness of these airplanes in finance.

These airplane models are manufactured in and are type certificated for operation in the United States under the provisions of § 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent degraded operation of the THSA due to the entrance of water into the ball nut, and consequent reduced controllability of the airplane. This AD requires accomplishment of the actions specified in the applicable AOT described previously. This AD also requires that operators report results of inspection findings to Airbus.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-135-AD.” The postcard will be date stamped and returned to the commenter.

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.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Requirements for testing blood donors for hepatitis B surface antigen (HBsAg) and antibody to human immunodeficiency virus (anti-HIV) are currently codified in part 610 (21 CFR part 610), and requirements for performing a serological test for syphilis are codified in part 640 (21 CFR part 640). The agency has issued various guidance documents to registered blood and plasma establishments providing recommendations for testing for antibody to hepatitis B core antigen (anti-HBc), antibody to human T-lymphotropic virus types I and II (anti-HTLV I/II), antibody to hepatitis C virus (anti-HCV), and HIV-1 p 24 antigen. The purposes of the guidance documents are to assist blood and plasma establishments in protecting the safety of the blood supply and to establish policies with the intent of promoting consistency in the industry. These guidance documents represent the agency's current thinking on the appropriate testing of human blood donors for evidence of infection due to various communicable disease agents. Through inspection, we (FDA) determined that blood and plasma establishments generally have been following these recommendations. However, there have been instances where there have been variations in testing and in the determination of suitability of the blood based on the testing results. Accordingly, we proposed a regulation requiring testing consistent with our current recommendations and industry practice.

In the Federal Register of August 19, 1999 (64 FR 45340), we published a proposed rule to revise the testing requirements codified in part 610. The proposed rule would require:

• Each donation of human blood or blood component, including autologous donations, to be tested for evidence of infection due to HIV, types 1 and 2; HBV; HCV; and HTLV, types I and II;

• Each donation that tests reactive for any of the required screening tests for evidence of infection due to communicable disease agents, to be further tested using a supplemental (additional, more specific) test that has been approved for such use by FDA;

• The required testing to be performed by a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or meeting equivalent requirements as described by Health Care Financing Administration (HCFA), and registered with FDA in accordance with part 607 (21 CFR part 607);

• Deferral from future donations of donors who test reactive;

• Criteria for release or shipment of human blood or blood components prior to completion of testing under limited circumstances;

• Restrictions on shipment or use of human blood or blood components that test reactive when screened for evidence of infection; and

• Manufacturers of approved test kits used for testing donations of human blood and blood components for evidence of infection due to communicable disease agents, or for use in the diagnosis, or monitoring of HIV, to verify an acceptable sensitivity and specificity of each lot of test kit using a reference panel obtained from FDA, or an FDA designated source, when available.

We provided 90 days for comments on the proposed rule.

In the same Federal Register issue (64 FR 45355), we proposed new § 630.6 to require blood and plasma establishments to notify donors of deferral based on evidence of infection due to communicable disease agents or failure to satisfy donor suitability criteria. We intended to finalize the donor notification rule and issue it simultaneously with this document.

On November 9, 1999, we announced a public workshop held on November 22, 1999, and extended to December 22, 1999, the comment period on both proposed rules, entitled “Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents,” and “General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors.” The purpose of the public meeting was to provide a public forum for gathering information and views regarding the proposed rules.

We have written the final rule using plain language consistent with the presidential memorandum on plain language in government writing, dated June 1, 1998. We have adopted the plain language approach to make the rule more accessible and understandable to the public. As a result, we have used pronouns in describing who must comply, e.g., “you” refers, in the appropriate context, to an establishment that collects blood or blood components or to an establishment that is a consignee of a collecting establishment. We also have used “must” instead of “shall,” and are using charts to clarify provisions.

In § 610.40(a) of the final rule, we require the use of screening tests for evidence of infection due to communicable disease agents, i.e., HIV, types 1 and 2; HBV; HCV; and HTLV, types I and II, for each donation of human blood and blood component. In § 610.40(b), we are requiring testing using one or more tests to reduce adequately and appropriately the risk of disease transmission. We are allowing for future advancements in testing methodologies by not specifying the test marker(s) for each disease agent. Further testing is required of all donations, including autologous (some exceptions apply) that are reactive when screened for evidence of infection due to any of the communicable disease agents, using supplemental (additional, more specific) tests approved for such use by FDA in § 610.40(e). (See section IV of this document.) We have eliminated the use of the term “repeatedly reactive” and replaced it with “reactive.” The terminology was revised to allow for future technology in testing, where the process of repeating an initial reactive result in duplicate would no longer be appropriate. However, for the test technologies recommended in current guidance, “reactive” means “repeatedly reactive,” because the manufacturers' instructions for current tests require duplicate retesting after an initial reactive result.

Specified exceptions to the testing requirements in § 610.40(c) are described as they apply to a dedicated donor (a donor whose collections are used by an identified recipient, see section V.B of this document), a donor of Source Plasma, a donor of blood or blood components intended as a component of, or used to prepare, a medical device (see section II.D of this document), and samples used or distributed for clinical laboratory testing or research purposes and not intended for administration to humans or in the manufacture of a product.

In § 610.40(d) of the final rule, we have created a separate paragraph for autologous donations. Testing of autologous donations is not required under this section unless an autologous donation of blood or blood components potentially could be used for allogeneic transfusion or shipped to another establishment. If shipped to an establishment that does not permit the use of autologous donations for allogeneic use, only the first donation in each 30 day period must be tested as discussed in section V of this document.

In § 610.40(f), testing required under § 610.40(a), (b), and (e) must be performed by a laboratory registered under part 607 and either certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) under 42 CFR part 493 or has met equivalent requirements as determined by HCFA under those provisions. Therefore, § 607.65(g) is removed, formerly exempting from registration clinical laboratories that are approved for Medicare reimbursement and are engaged in the testing of blood products in support of other registered blood establishments.

Release or shipment prior to completion of testing in § 610.40(g) may occur in appropriately documented emergency medical situations, or when approved in writing by FDA, provided that the shipping establishment notifies the consignee that test results are not yet available, that the tests for communicable disease agents are completed as soon as possible, and that the results are provided promptly to the consignee.

Under § 610.40(h), an establishment must not ship or use blood or blood components that have a reactive screening test for a communicable disease agent(s) or reactive serological test for syphilis, or that were collected from a donor with a previous record of a reactive screening test for a communicable disease agent(s) or reactive serological test for syphilis. Exceptions to this requirement are:

• For blood and blood components from autologous donors when labeled as required in § 610.40(d);

• When approval in writing is obtained from FDA and the blood or blood component is labeled as required under § 610.40(h)(2)(ii);

• Samples for use or distribution, if intended for clinical laboratory testing or research and not intended for administration in humans or for further manufacturing use;

• When a collection from a donor with a record of a reactive screening test result tests negative and the donor is shown, or previously was shown, to be suitable by an acceptable requalification method; and

• When a collection from a donor, who tests reactive for anti-HBc and otherwise is determined to be suitable, may be used for further manufacturing into plasma derivatives without prior FDA approval or the “BIOHAZARD” legend.

Under § 610.41(a), any donor of blood and blood components, including an autologous donor, who tests reactive for a communicable disease agent(s) described under § 610.40(a) or reactive with a serological test for syphilis must be deferred from future donations. Exceptions apply as follows:

• A donor who tests reactive for anti-HTLV I/II or anti-HBc only once is permitted to donate again without being deferred from further donation unless there is further testing using an approved supplemental (additional, more specific) test;

• A deferred donor who tests reactive for HIV, types 1 and 2, HBV, HCV, HTLV types I and II, or syphilis may donate blood or blood components to be shipped or used under the provisions described in § 610.40(h)(2)(ii);

• A deferred donor who showed evidence of infection due to HBsAg when previously tested may donate blood or blood components to be used in the preparation of Hepatitis B Immune Globulin (Human) provided the donor's current donation tests nonreactive for HBsAg and the donor otherwise is determined to be suitable;

• A deferred donor who tests reactive for anti-HBc or for evidence of infection due to HTLV, types I and II, may serve as a donor of Source Plasma collected for further manufacturing use;

• A deferred donor who tests reactive by a screening test for syphilis may serve as a donor of human blood and blood components, if the donation is further tested by an adequate and appropriate test demonstrating that the reactive screening test is a biological false positive; and

• A deferred donor who tests reactive for a communicable disease agent(s) described under § 610.40(a) or reactive with a serological test for syphilis may serve as an autologous donor.

Under new § 630.6 in the donor notification rule found elsewhere in this issue of the Federal Register , all deferred donors, including those deferred donors who may serve as donors under specified conditions described in § 610.41, must be notified of their deferral.

Under § 610.41(b) the regulations permit the reentry of a deferred donor into the donor pool when the donor is requalified by a process or method (algorithm) approved by FDA for such purpose.

In the proposed rule, we discussed the need for labeling of medical devices manufactured from reactive blood or blood components. In the final rule, we have changed the text of § 610.42 to require labeling for all medical devices that contain blood or a blood component as a medical device component, and not just in vitro diagnostic products. Under § 610.42(a), when a medical device contains human blood or a human blood component as a component of the final device and the human blood or blood component was found to be reactive by a screening test for a communicable disease agent(s) or reactive by a serological test for syphilis then the device labeling requires a warning statement indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified communicable disease agent(s). Other labeling requirements in subchapter H (Medical Devices) of chapter I would also apply. We also are allowing for an exemption approved by FDA to the statement of warning in circumstances where the reactivity of the human blood or blood component in the device presents no significant health risk through the use of the device.

In proposed § 610.44, manufacturers of test kits would be required to use, when available, a reference panel obtained from FDA or from a FDA designated source to verify the sensitivity and specificity of kits approved for use in testing donations of blood and blood components for communicable disease agents listed in § 610.40(a) and for an HIV test approved for use in the diagnosis and monitoring of HIV.

In the final rule, we are amending the requirements to clarify that when available and appropriate, a manufacturer must use panels that have been provided or identified by FDA to verify acceptable sensitivity and specificity of kits used to test donations of human blood and blood components, including licensed supplemental (additional, more specific) tests. The agency is making this change after reviewing 21 CFR 660.46. That regulation recognizes that official lot release may not be required after a manufacturer consistently produces a product that meets specifications. Consistent with this policy, the agency has recognized that less strict reference standard testing requirements may be appropriate in some situations. Accordingly, FDA has revised 1§ 610.44 to require use of reference panels only when such use is appropriate and panels are available. Moreover, FDA may determine that reference panel testing of each lot is not appropriate, based on a manufacturer's consistent prior production of products of acceptable sensitivity and specificity. In that situation, intermittent testing of lots may be appropriate.

FDA also is clarifying that § 610.44(a)(2) requires manufacturers of an HIV test kit approved for use in diagnosis, prognosis, or monitoring to use an FDA provided or designated reference panel, when available and appropriate to assure acceptable sensitivity and specificity of each lot of test kit. When available and appropriate, FDA expects the manufacturer to perform testing using the panel to assure that each lot meets acceptable sensitivity and specificity.

The agency also is making a conforming amendment to § 809.20(b) (21 CFR 809.20(b)), to make clear that § 610.44 applies to all HIV test kits that are biological products, and are approved for diagnosis, prognosis, or monitoring, including any such kits reviewed under the medical device authorities.

In the proposed rule, we stated that as technology and scientific knowledge advance, and the demands placed on the blood industry change, there will continue to be instances when a regulation will become outdated or where unanticipated circumstances may warrant a departure from a regulation. To allow for flexibility in such cases, we discussed the availability of approval for exemption upon written request from a manufacturer to FDA. We also noted that, under § 640.120, applicants may submit requests for exceptions or alternatives to regulations regarding blood, blood components, or blood products. Consistent with this policy, we created a similar provision in the final rule that is applicable to the labeling of medical devices in § 610.42, and distribution of lots found not to be acceptable for sensitivity and specificity in § 610.44. We would approve an exception or alternative under these sections only if we concluded that the safety, purity, potency, and effectiveness of the final product were adequately assured. Manufacturers may submit, in writing to FDA, a request for an exception or alternative to §§ 610.42(a) and 610.44(b). In limited circumstances, a request and approval may be made orally followed by a written request and written approval.

We also made technical changes to existing regulations, consistent with this rulemaking. We removed §§ 606.121(g), 607.65(g), 610.45, 640.2(d), and 660.42. We revised §§ 640.5(f) and 640.67 for consistency with § 610.40, and in §§ 606.121(h)(2) and (h)(3), 640.14, 640.23(a), 640.33(a), and 640.53(a) we deleted “§ 610.45.” We have amended §§ 606.121(e)(5)(ii) and 640.70(a)(2) to conform with the labeling requirement in § 610.40(h)(2)(ii)(E), and amended § 809.20(b) to conform with § 610.44.

In the proposed rule, we solicited comments, with supporting data, from the public in regard to the value of such a test as a marker of high risk behavior, as a surrogate test for other communicable diseases, and as a screen for syphilis in blood and blood components to prevent transfusion-related transmission. We recognized that many scientists, including some members of the blood banking community, continue to advocate the elimination of the serological test for syphilis as a testing requirement. Comments were received and are discussed in comment 28 of this document. We have concluded that there are insufficient data to justify eliminating the requirement for a serological test for syphilis. Therefore, §§ 640.5(a) and 640.65(b) remain in effect at this time. The agency remains interested in receiving scientific data to clarify the value of performing serologic tests for syphilis on donations of blood and plasma.

Over time, we have issued guidance representing the agency's current thinking on the adequate and appropriate testing of blood and blood component donations for evidence of infection due to various communicable disease agents. Because we are not specifying the test or tests to be used in this regulation, we are listing in the following table the test or tests we currently believe reduce adequately and appropriately the risk for transmission of communicable disease agents.

As technology advances, we intend to regularly issue guidance describing those tests that we believe would adequately and appropriately reduce the risk of transmission of communicable disease agents. Unless we determine that prior public participation is not feasible or appropriate, we intend to issue such guidance in draft, giving the opportunity for public comment and for manufacturers to prepare to use any appropriate new testing technologies. When prior public participation is not feasible or appropriate, for example, when immediate action is necessary to protect the public health, we may immediately implement the guidance.

We have prepared a list of guidance documents that currently are applicable to these regulations. They are listed in order by date of issuance.

• Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg); December 2, 1987

• HTLV-I Antibody Testing; November 29, 1988

• FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc); September 10, 1991

• Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing; December 12, 1991

• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Encoded Antigen (Anti-HCV); April 23, 1992

• Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products; April 23, 1992

• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) [Supplements previous guidance April 23, 1992]; August 5, 1993

• Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis; December 22, 1993

• Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen; August 8, 1995

• Additional Recommendations for Donor Screening with a Licensed Test Kit for HIV-1 Antigen [Supplements previous guidance August 8, 1995]; March 14, 1996

• Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) [Supplements previous HCV guidance—April 23, 1992 and August 5, 1993]; May 16, 1996

• Guidance for Industry: Donor Screening for Antibodies to HTLV-II; August 15, 1997

• Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing; June 11, 1998

The guidance documents referenced in this document or otherwise applicable to the testing of donors of blood and blood components may be obtained from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance documents may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by FAX by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. Persons with access to the Internet may connect to CBER at http://www.fda.gov/cber/publications.htm.

We received 24 letters of comment on the proposed rule, most of which raised multiple issues. The comments were submitted by blood centers, hospitals, transfusion services, trade associations, and professional associations. A number of comments expressly supported our revision of communicable disease testing requirements to incorporate the agency's guidance and industry practice into one comprehensive regulatory framework to help ensure the safety of the blood supply. A summary of the comments and the agency's responses follow.

In the proposed rule, each donation of autologous blood and blood component would be tested for evidence of infection due to the following communicable disease agents: HIV, types 1 and 2; HBV; HCV; and HTLV, types I and II. The testing would be performed using screening tests approved for such use by FDA. One or more such tests would be performed as necessary to reduce adequately and appropriately the risk of transmission of communicable disease. Restrictions on shipment or use would not apply to autologous blood and blood components provided the autologous blood and blood components are labeled appropriately. We requested comments on alternatives (including the rationale) to testing each autologous donation, such as procedural or labeling improvements. A majority of comments submitted to us responded to this issue.

(Comment 1) Six comments support testing autologous donations in the same manner as allogeneic donations. The comments argue that a significant error rate in the use of autologous blood for allogeneic use or use in preparing a product, makes the current risks to recipients of blood and blood components unacceptable. They further argue that testing will reduce these risks, as well as the risk to healthcare workers from inadvertent exposure. Several of these comments recommend that autologous donations testing reactive for a communicable disease agent(s) should not be exempt from the restrictions on shipment and use in the proposed rule. They argue that positive donations of autologous blood should be discarded to protect the health of healthcare workers and to prevent inadvertent use of such autologous blood for allogeneic transfusions.

Eleven comments oppose testing of autologous donations for evidence of infection due to communicable disease agents. These comments argue that testing would not significantly reduce the risk of inadvertent allogeneic transfusions with autologous blood and blood components because testing alone does not address the process errors that cause inadvertent allogeneic transfusions. Errors in labeling and handling autologous blood will occur regardless of whether donations are tested. Several comments argue that we presented no data to suggest testing will reduce inadvertent allogeneic transfusion. One comment points out that inadvertent allogeneic transfusion errors occur despite the fact that an estimated 60 to 70 percent of autologous donations currently are tested. The comments that argue against testing instead support regulation that focuses on improving quality assurance systems. These comments recommend optimizing labeling, separating processing paths and segregating storage for autologous donations, as well as requiring multiple identifications of recipients to address directly all (autologous and allogeneic) transfusion errors. Finally, comments opposed to testing autologous donations argue that the significant costs of testing are unwarranted given the lack of clinical utility. They argue that in many cases, particularly in small, rural hospitals where patients will have few alternatives, the costs of testing will be prohibitive and will result in reduced availability of autologous services. Several comments also suggest that reduced availability of autologous donations will result in an increase in allogeneic use with its attenuated risks outweighing any minor increase in safety from testing autologous donations.

A number of comments recommend an intermediate position between testing all autologous donations and testing none. Three comments support testing only one in a series of autologous donations, noting that many autologous donors donate multiple donations in a short timeframe, therefore, testing each donation would result in significant costs without any appreciable increase in safety to the blood supply. One comment calls for testing autologous donations once in 30 days if the autologous donation is to be shipped from the collection establishment before transfusion. If the donation is collected and transfused in the same facility, the comment recommends no testing be required. The same comment supports labeling all autologous donations with a unique label stating “FOR AUTOLOGOUS USE ONLY” and all reactive or untested donations with a “BIOHAZARD” legend. Further, the comment calls for prohibiting establishments from using autologous donations as allogeneic donations. The comment argues that requiring testing every 30 days for shipped autologous donations, labeling changes, and preventing the use of autologous blood and blood components for allogeneic transfusion are better, more cost-efficient methods of protecting patients and health care personnel.

Based on the comments submitted and our own evaluation, the agency has concluded that its proposal to test all autologous donations in the same manner as allogeneic donations should be amended. While communicable disease testing plays a major role in improving the safety of the allogeneic blood supply, we are not convinced that the testing of all autologous donations is necessary to improve the safety of the general blood supply. It is the inadvertent improper use of autologous donations, rather than the product itself, which poses risk to the public health. Many of the incidents involving autologous donations that compromise transfusion safety are caused by process or clerical error. As one comment points out, these errors occur regardless of whether the autologous donation is tested and its communicable disease status is known. We are persuaded that such errors involving autologous donations can be better addressed by changes in labeling and processing of autologous donations. We believe that clearly marking autologous donations as “DONOR UNTESTED,” as well as with the autologous label (§ 606.121(i) (21 CFR 606.121(i))), will alert healthcare workers that they could be handling potentially infectious products and should take appropriate precautions. We believe that not requiring testing of autologous donations will help assure continued autologous services at certain small, rural blood establishments, which do not use autologous donations for allogeneic use. We believe that these labeling changes will sufficiently increase the safety of autologous transfusions without compromising the availability of these services.

However, we have concluded that under certain circumstances there is a potential risk to blood safety from autologous donations, and under those circumstances labeling changes alone are insufficient to protect the public health. First, blood establishments that permit autologous donations to be used for allogeneic transfusions run a potentially greater risk of erroneous transfusion of an autologous donation to an unintended recipient. We are requiring that establishments that maintain a program permitting allogeneic use of autologous donations test each autologous donation collected regardless of whether the particular blood or blood component is “crossed-over” for allogeneic use. Positive and reactive donations must be labeled with a “BIOHAZARD” legend as well as with the label “FOR AUTOLOGOUS USE ONLY” as required under § 606.121(i). Autologous donations that test negative for evidence of infection due to communicable disease agents must be labeled “FOR AUTOLOGOUS USE ONLY” as further specified under § 606.121(i). The agency believes that blood establishments that use autologous donations for allogeneic uses should be subject to these additional safety measures to prevent erroneous allogeneic uses. The agency believes that for such establishments the additional margin of safety achieved by testing all donations in the establishment's inventory and labeling reactive donations with a “BIOHAZARD” legend is necessary to protect the public health.

The second area in autologous transfusion services that presents additional safety concerns is the shipment of autologous products from the collection facility to another establishment. Errors, including clerical errors in inventory management and breakage of autologous donations, may occur when the product is handled by a variety of individuals and facilities throughout collection, transport, storage, and transfusion. We are requiring that blood establishments that ship autologous products to other establishments that do not use autologous donations for allogeneic use must test the first autologous donation collected at the beginning of each 30-day period for evidence of infection due to communicable disease agents. We believe a minimum requirement of testing the autologous donor's blood at least once in 30 days is sufficient because autologous donations are usually given in a series over a short timeframe. Because these donations are not intended to be transfused into any other recipient than the donor, testing once in 30 days for evidence of infection due to communicable disease agents will give an added measure of safety to those handling the blood without the costs of testing each autologous donation. Thus, if an autologous donor donated three times over a 30-day period and the establishment ships the autologous donations to another establishment that does not allow use of autologous donations for allogeneic transfusion, the rule requires, at a minimum, that the establishment test the first collection only. If the donor donated a fourth time on the 31st day or later, the establishment must test the fourth collection.

(Comment 2) One comment raises several additional arguments against testing autologous donations including: Testing may give a false sense of increased protection resulting in decreased attention and more errors; testing may result in denial of services to patients or loss of autologous donor programs; and testing of autologous donations constitutes the practice of medicine since autologous donors are patients under a doctor's care.

We do not believe that testing of autologous donations will result in decreased attention and more errors. Communicable disease testing of allogeneic blood and blood components has been an important and effective tool to ensure the safety of the blood supply. Testing of autologous donations, which are shipped to or collected in an establishment that maintains a program that uses autologous blood and blood components for allogeneic transfusion will provide an additional margin of safety against a potentially greater risk of error. We do not believe that communicable disease testing of autologous donations will result in a denial of such services to patients or in the loss of such programs. We are not requiring testing of autologous blood and blood components except when an establishment has a program allowing the use of autologous donations for allogeneic transfusion, or ships the autologous donations from the collecting facility. We believe this approach allows services and programs for autologous collections to continue while protecting potential allogeneic recipients and healthcare workers who may be exposed to biohazardous blood or blood components.

The comment views the testing of autologous donations as practice of medicine. However, we do not consider testing of autologous donations to be practice of medicine, but to be a safeguard in protecting the public health when autologous donations are made available for allogeneic use or when others may be exposed to potentially hazardous donations during shipment of autologous donations by the collecting establishment. This policy responds to a recommendation in the February 1997 report issued by the General Accounting Office entitled “Blood Supply: FDA Oversight and Remaining Issues of Safety.”

(Comment 3) Two comments argue that testing and labeling autologous blood and blood components can seriously jeopardize the confidentiality of the donor's communicable disease status.

We do not believe the required testing and labeling of autologous donations will seriously compromise the donor's confidentiality. The final rule does not require most autologous donors to be tested, and labeling on untested autologous donations will not raise confidentiality issues. In addition, the label will not identify in any manner the donor's particular communicable disease status. The “BIOHAZARD” legend on donations from autologous donors who test positive or reactive will serve as a necessary alert for blood healthcare workers and help prevent transfusion errors. We recommend that autologous donors be informed beforehand if their donations will be tested for evidence of infection due to communicable disease agents. Thus, autologous donors may choose not to donate in a setting where testing is required.

(Comment 4) Seven comments raise the issue of what to do with autologous blood or blood components that test reactive by one or more of the communicable disease agents identified in § 610.40(a). Several of these comments point out that blood establishments are under ethical and legal constraints that would prevent them from discarding test positive autologous donations. Several comments suggest that under a recent Supreme Court decision it may be a violation of the American with Disabilities Act (“ADA”) to deny HIV-infected patients the right to use their own blood. Two comments strongly support discarding autologous donations testing reactive. These comments argue that the risks from keeping these positive donations in blood inventories are too great. The comments argue these donations should be treated similarly to blood from a positive allogeneic donor and discarded.

We are not prohibiting blood establishments from transfusing positive donors with their own blood. These donations, however, if made available for autologous use must be labeled “FOR AUTOLOGOUS USE ONLY” and also with a “BIOHAZARD” legend.

(Comment 5) Several comments call for prohibiting the use of autologous donations for allogeneic transfusion for all blood collection establishments. The comments argue that the benefit of testing would be negated if test positive autologous donations remain in the system subject to the processing errors that can occur when use of autologous donations for allogeneic transfusions is permitted.

The agency has determined that this final rulemaking is not the appropriate venue to institute a requirement prohibiting use of autologous donations for allogeneic use. However, we believe that this issue should be considered further in the more general context of medical errors. In the interim, we believe that requiring blood establishments that continue the practice of using autologous donations for allogeneic transfusions to test and appropriately label all their autologous donations will help control errors involving autologous donations testing reactive for a communicable disease agent(s).

(Comment 6) Four comments point out that the proposed rule does not address perioperative autologous blood collections. Two comments suggest that requiring testing of perioperative collections would effectively eliminate them because testing would not be completed in time for donations to be used. One comment suggests the final rule should contain an exception for intraoperatively salvaged blood.

We are not proposing testing of perioperative blood collections. These blood or blood components are collected and used within the same facility where the operation is being performed, and are not intended for allogeneic use. They also do not become part of the transfusion center's or blood collection establishment's inventories. Therefore, we do not consider perioperative blood or blood component donations subject to testing for evidence of infections under the purview of the final rule.

(Comment 7) Four comments suggest that we deal with the issue of the inappropriate use of recovered plasma for further manufacture from untested or communicable disease marker reactive autologous blood by banning the use of untested or reactive recovered plasma or by requiring testing of autologous blood to be used for salvage.

Under 21 CFR 606.100(b)(18), blood establishments are required to establish and maintain standard operating procedures (SOP's) for recovered plasma. If a blood establishment intends to use recovered plasma from an untested donation for further manufacturing use, the donation would then be considered an allogeneic donation subject to the testing requirements for allogeneic donations under the final rule. The use of untested or reactive autologous blood for further manufacturing is prohibited unless exempted under § 610.40(h)(2).

We requested comments on whether to exempt from testing for evidence of infection due to communicable disease agents each donation from a dedicated apheresis donor (defined in section I.B of this document) and instead test such donors only once in each 30-day period.

(Comment 8) Eight comments responded to this request. One comment opposes a once in each 30-day period testing exception for dedicated apheresis donors, arguing that recipients of these donations are entitled to the same protection as other recipients of blood components. The remaining seven comments support allowing testing of dedicated apheresis donors only once every 30 days. These comments cite the fact that dedicated apheresis donations are often used for patients in dire situations who are unable to wait for each donation to be tested. They argue that dedicated apheresis donations tested only once in each 30-day period would not present a safety concern because new tests have substantially increased the reliability of the first donation's test results; because subsequent donations during the 30-day period would create little additional risk to the recipient, since the first donation would expose the recipient to any undetected infection; and because new risk of exposure could be caught by taking the donor's medical history (including health and social history screening) on the day of each subsequent collection. (See 21 CFR 640.3(a).)

Based on the comments submitted and the agency's own evaluation, we have concluded that donations from dedicated apheresis donors must be tested for evidence of infection due to communicable disease agents at the first donation and at a minimum of once at the beginning of each successive 30-day period. This exception from universal testing will provide the recipient of dedicated apheresis donations with adequate protection against disease transfer since the test results would be unlikely to change within the 30-day period. We also believe this exception will limit donor exposure when the patient needs frequent transfusions and will help avoid delaying treatment of patients in need of emergency transfusions.

(Comment 9) One comment suggests that the communicable disease agent testing should be allowed near the time of the first collection to facilitate expedited release of dedicated apheresis donations to patients in need.

We have reviewed the comment and will consider permitting communicable disease agent testing prior to collection of the first dedicated donation in the context of creating specific standards for dedicated donations in future rulemaking.

(Comment 10) Two comments call for use of an abbreviated donor screening questionnaire for dedicated apheresis donors.

Since we are limiting testing for evidence of infection due to communicable disease agents to the first donation in each 30-day period, we believe that the screening process plays an even more important role in evaluating the safety of the blood or blood component being collected from the dedicated donor. The possible implications of an abbreviated screening are not in the scope of this rulemaking, and are under study for future rulemaking.

(Comment 11) Two comments suggest extending this exception from universal testing to other dedicated blood components (e.g. dedicated granulocyte donors; parent to child donations of plasma or red blood cells).

We agree with this comment. We believe that donations from dedicated donors should be treated alike in regards to communicable disease testing. Accordingly, the agency has extended the exception allowing testing for evidence of infection due to communicable disease agents to the first donation in each 30-day period for all donations of blood and blood components from dedicated donors to a single, identified recipient. Syphilis testing is required, at a minimum, for the first donation in each 30-day period in addition to the other communicable disease agents listed in § 610.40(a).

(Comment 12) One comment also calls for extending the exemption to other non-infectious tests required for donations from dedicated apheresis donors, such as ABO, Rh, red cell antibody screening.

We disagree with this comment. Tests such as ABO, Rh, and red cell antibody screening are part of matching the donation to the donor and, therefore, part of quality assurance processes.

(Comment 13) One comment suggests that subsequent donations from dedicated apheresis donors should not be labeled as untested since the test results from the first donation should apply to subsequent donations.

We agree with this comment. We are requiring that donations subsequent to the first tested donation in each 30-day period from dedicated donors, including apheresis donors, be labeled “DONOR TESTED WITHIN THE LAST 30 DAYS.”

We are aware that there may be occasions where the dedicated donations are no longer needed by the identified recipient. When an untested donation is to be used for transfusion to another recipient or for further manufacturing, the establishment must assure that all suitability criteria under § 640.3 are met and that testing required under § 610.40 is completed and that the donation tests nonreactive before use.

In proposed § 610.40(c), we would require that each donation found to be reactive by a screening test for evidence of infection due to communicable disease agents be further tested whenever a supplemental (additional, more specific) test has been approved for such use by FDA.

(Comment 14) Three comments support our proposal to further test reactive donations whenever a supplemental (additional, more specific) test has been approved for such use by FDA. These comments point out that this information is relevant to the donor and part of the usual and customary business practice for blood centers to provide. One of these comments also suggests that requiring such testing will provide test kit manufacturers with the economic incentive to develop supplemental tests for less common viruses for which donors are screened.

Four comments oppose our mandating supplemental testing. These comments argue that there is not a sufficient public health concern and that the costs are too burdensome. The comments suggest that our regulatory concerns should be limited to deferring reactive donors and labeling positive donations. Several of these comments argue that supplemental testing has no impact on blood safety and is a medical decision to be made by the donor's physician. Others suggest that blood centers do supplemental testing voluntarily if they intend to reenter donors; so supplemental testing should not be required.

Historically, we have recommended in guidance supplemental testing of reactive samples and, for HIV, we have required supplemental testing in § 610.46(b). We consider supplemental testing as part of communicable disease control, necessary in protecting public health. Screening tests are designed to be highly specific for the tested marker. Nevertheless, false positives occur due to sample contamination, cross-reactivity, or nonspecific causes. In § 610.40(e), we are requiring that reactive samples be further tested by a supplemental (additional, more specific) test, when available, that has been approved for such use by FDA. Although a donor must be deferred based on a reactive screening test, the blood and plasma establishment should use the information obtained through supplemental testing to notify and counsel the deferred donor. Providing donors with accurate information about their communicable disease status and deferral as soon as possible helps ensure a healthy donor population. Blood and plasma establishments also can use information from supplemental testing to evaluate the donor for possible reentry into the donor pool. Requalification of donors contributes to blood availability, which also is a public health concern. Therefore, FDA believes supplemental testing has a direct impact on blood safety in preventing communicable disease transmission and in optimizing blood availability.

(Comment 15) Several comments object to HCV supplemental testing in particular because there is currently no requirement for lookback or product retrieval and there is no reentry algorithm in place.

We disagree with the comments. We consider supplemental testing part of blood safety by providing deferred donors with accurate, timely information regarding their deferred status and possible transmission of communicable disease. Currently, we allow reentry of donors who test reactive by a multiantigen screening test for HCV. Reentry into the donor population must follow a method or process approved by FDA. This process includes the use of a supplemental test, e.g., recombinant immunoblot assay 3.0 (RIBA 3.0). We have issued draft guidance on our current thinking on HCV “lookback” (see section IV of this document for description on how to access the draft guidance document); we intend to finalize this guidance and to propose new regulations in a future rulemaking for “lookback” when donors test reactive for HCV.

(Comment 16) One comment objects to supplemental testing of autologous donations. The comment objected, in part, because of the costs associated with testing each donation from autologous donors.

Under the final rule, we require testing of autologous donations only where there is a public health risk, i.e., where an establishment has a program allowing the use of autologous donations for allogeneic transfusion, or where a collecting establishment ships autologous donations. For those donations of autologous blood and blood components that are required to be tested, we also are requiring blood establishments to further test such donations using supplemental tests. If an autologous donation is reactive in screening tests, blood establishments are required to defer the autologous donor from future allogeneic donations. The deferred autologous donor has the same need as the deferred allogeneic donor for accurate information regarding his or her possible infectious status, and the information from supplemental testing may prevent the donor from spreading the infection. Thus, we believe that supplemental testing of autologous donations is just as necessary to blood safety and public health as supplemental testing of allogeneic donations. For those autologous donors with a record of a positive supplemental test for a specific communicable disease agent, the establishment is not required to perform the supplemental test again.

(Comment 17) Two comments argue that the approved supplemental tests are not always the best method of confirmatory testing, pointing to nucleic-acid-based testing (NAT) for HCV and HIV. The comments also suggest allowing blood establishments to use NAT testing and leave the decision to the donor's physician whether other supplemental tests are warranted medically.

In structuring the proposed rule, we intended to allow for advancements in testing technology without further rulemaking. We built into the requirement for supplemental testing of reactive donations the ability for blood and plasma establishments to use different testing methods as long as those tests have been approved by the agency. NAT is not yet available as a supplemental testing method and cannot now be used in lieu of licensed or approved tests. However, we expect further development in NAT, both as a screening and supplemental test, and intend to issue guidance on the use of such testing in the future.

(Comment 18) Three comments suggest that to reduce costs and delays supplemental tests need be performed only on the first reactive donation in a series of donations.

Supplemental testing, when available, is required for each donation that tests reactive for evidence of infection due to a communicable disease agent(s) listed in § 610.40. We agree with the comments in part, and applied the suggestion to autologous donors. We are making two exceptions to performing supplemental testing on each reactive donation. The first exception requires, at a minimum, that supplemental testing be performed on the first reactive autologous donation in each 30-day period. The second exception is when an autologous donor has a positive supplemental test of record. In that instance, the supplemental test is not required to be performed on subsequent autologous donations.

In proposed § 610.40(e), we would allow the use or shipment prior to test results of human blood or blood components under two circumstances: Appropriately documented medical emergency situations; or when approved in writing by FDA. Use or shipment prior to test results may occur, provided the consignee is notified that test results are not available, the tests for evidence of infection due to communicable disease agents are performed as soon as possible after release or shipment, and the results are provided promptly to the consignee.

(Comment 19) Several comments support allowing use or shipment of donations prior to testing in medical emergencies and routine shipment for further manufacturing use. One comment opposes any use or shipment prior to testing.

We believe these exceptions are necessary to ensure the continued availability of blood products in emergency situations and when products require rapid preparation, e.g., Source Leukocytes. In either instance, the completion of testing prior to shipment or use may not be feasible. The regulations require the blood or plasma establishment to document the emergency release or shipment of blood or blood components prior to completion of testing. If the blood or plasma establishment ships blood or blood components for further manufacturing use prior to completion of testing, the blood establishment must obtain prior approval from FDA. In either instance, the blood or plasma establishment must complete testing as soon as possible thereafter, and must notify the consignee of test results as soon as they are available.

(Comment 20) One comment argues that a blood establishment should not be required to obtain approval from FDA before shipping untested blood or blood components for further manufacturing use. The comment contends that there is no public health concern since the blood or blood components are not released yet. The comment asserts that a request for FDA approval would delay manufacture of the biological product. The comment asks that any such requests be automatically approved 30 days after submission to FDA.

We believe it is essential as a public health safeguard that blood or plasma establishments shipping blood and blood components for further manufacturing use prior to completion of testing obtain prior approval from FDA and submit their SOP's for review. However, the blood or plasma establishment must submit its SOP's and obtain prior approval only before its first shipment—not, as some comments seem to suggest, before each shipment. This requirement of a single submission will not delay the manufacture of a biological product. We believe that this provision will expedite the manufacturing process by allowing communicable disease testing to be completed after shipment, but before further manufacturing use. Prior approval is necessary to help ensure that a blood or plasma establishment is following proper procedures in shipping potentially infectious blood and blood components for further manufacturing use.

(Comment 21) One comment asks FDA to clarify whether proposed § 610.40(e)(2) addresses the transfer of untested donations within a multifacility manufacturer for labeling purposes.

Requests to ship blood and blood components prior to testing between facilities within a multifacility manufacturer for labeling purposes should be submitted through the license application for that product. FDA will review those applications on a case-by-case basis.

In proposed § 610.41, we would require donors testing reactive for evidence of infection due to a communicable disease agent or reactive for a serological test for syphilis be deferred from future donations of blood and blood components. Proposed exceptions to this requirement are: (1) Autologous donors; (2) plasmapheresis donors with a reactive serological test for syphilis under § 640.65; (3) donors who test reactive for anti-HTLV, types I or II, or anti-Hepatitis B core (anti-HBc) on only one occasion; (4) donors who test reactive for anti-HTLV, types I or II, or anti-HBc may serve as donors of Source Plasma; (5) deferred donors testing reactive for evidence of infection due to a communicable disease agent may serve as donors for blood or blood components when used following the requirements for restriction on shipment or use; (6) deferred donors showing evidence of infection due to hepatitis B virus when previously tested, may donate blood or blood components in the preparation of Hepatitis B Immune Globulin (Human) provided their current donations test negative for HBsAg and the donor is determined otherwise to be suitable; (7) donors testing reactive with a serological test for syphilis and found negative by an approved specific treponemal test; and (8) previously deferred donors later found to be suitable as donors of blood or blood components by a method or process acceptable for such purposes by FDA.

(Comment 22) One comment supports and one comment opposes allowing donors testing reactive for anti-HTLV, type I or type II, or anti-HBc to serve as donors of Source Plasma.

In the proposed rule, we explained that the communicable disease agents HTLV, types I and II, are highly cell-associated. It is well established that HTLV, types I and II infection may be transmitted to recipients by the transfusion of cellular blood components from infected donors. Conversely, HTLV transmission has not been demonstrated by the transfusion of Plasma or Cryoprecipitate or by the use of products made from Source Plasma. Donors testing reactive for anti-HBc also do not present a risk of transmitting hepatitis B to recipients of plasma derivatives made from Source Plasma. Although blood that is reactive for anti-HBc, even when negative for hepatitis B surface antigen (HBsAg), has a low risk of infectivity for HBV and would not be suitable for transfusion, the plasma from such blood would be suitable for manufacture into plasma derivatives. In most cases, blood that is negative for HBsAg, but is reactive for anti-HBc would be from a donor who has cleared a hepatitis B infection. Such a donor would still have circulating anti-HBc and presumably would also have circulating anti-hepatitis B surface antigen (anti-HB's), which is hepatitis B neutralizing antibody. This neutralizing antibody is thought to contribute to the safety of immune globulin products. Additionally, all licensed human plasma derivatives undergo procedures that will inactivate HBV and HTLV. In the final rule, therefore, we continue to allow donors testing reactive for anti-HTLV, type I or type II, or anti-HBc to serve as donors of Source Plasma, consistent with the exemption that donors of Source Plasma need not be tested for anti-HTLV, types I and II, and anti-HBc.

(Comment 23) One comment suggests creating a temporary deferral category for donors found reactive with earlier generation EIA/screening test, but negative by more specific tests and reenter those donors if they test negative two times 6 months apart by a later more specific/sensitive test for the same marker.

We disagree with this comment on the basis that it is too specific for a regulation. The final rule contains a provision in § 610.41(b), which allows donors deferred based on reactive screening tests to be reentered into the donor pool if their blood subsequently tests negative for the same communicable disease agent and the donor is shown to be suitable to donate by a method or process approved by FDA. We have identified such donor reentry algorithms in guidance documents for some of the communicable disease agents listed in § 610.40 of the final rule. We expect, in the future, that blood and plasma establishments will submit for approval other reentry algorithms for the listed communicable disease agents.

(Comment 24) One comment requests that FDA explicitly allow the use of newly developed technologies to reenter donors under proposed § 610.40(f)(3).

We are allowing for further advancements in testing methodologies by not identifying specific tests to be performed within this rulemaking. We will continue evaluating new technologies related to reentry of deferred donors. We intend to issue guidance concerning our views on the use of those new technologies in screening and confirmatory communicable disease testing and as part of reentry algorithms for donors deferred based on results of screening tests for infection due to communicable disease agents.

(Comment 25) One comment stated that the exception to deferral in proposed § 610.41(a) should apply to donors who test reactive for anti-HTLV, types I and II, or anti-HBc on only one occasion, unless further testing under proposed § 610.40(c) is positive.

We agree in part with this comment. Once a supplemental test for anti-HTLV, types I and II, or for anti-HBc is approved, deferral will occur after a reactive screening test on one occasion regardless of the outcome of the supplemental (additional, more specific) testing. When a supplemental test is approved, we intend to issue guidance on when donor requalification is appropriate. Until such time, deferral will be based on reactive test results on two occasions.

(Comment 26) One comment requests clarification of the rule's impact on anti-HBc testing of blood and blood components for further manufacturing use.

The final rule does not require blood and plasma establishments to test blood and blood components for further manufacturing use (including Source Plasma) for anti-HBc. The rule does not prohibit establishments that choose to test such products for anti-HBc from using reactive blood or blood components in fractionation products and in in-vitro diagnostic products. A guidance issued to all registered blood establishments addresses labeling for injectable and non-injectable products using anti-HBc reactive blood components. (See the list of documents in section IV of this document (dated September 9, 1991).)

(Comment 27) For the manufacture of Hepatitis B Immune Globulin (Human) (HBIG), one comment supports the use of donors immunized to hepatitis B virus, as an alternative to using donors previously showing evidence of infection due to hepatitis B virus. The comment contends that this change would expand the possible supply. Another comment opposes the sole use of blood from donors immunized to hepatitis B virus in manufacture of HBIG for reasons related to protecting the public health.

We disagree with the first comment, and accept the second. In the final rule, we have permitted deferred donors previously showing evidence of infection due to hepatitis B virus to donate blood or blood components for use in the preparation of HBIG, provided that the current donations test nonreactive for HBsAg and that the donor is otherwise suitable. The agency has concluded that donors with antibodies to HBsAg should not be excluded. Donors having detectable antibodies to HBsAg have a spectrum of antibodies to different epitopes of the hepatitis B virus and, therefore, are acceptable or even desirable as donors for HBIG. Blood or blood components from such donors also may provide better protection against future mutations of the hepatitis B virus. We believe that HBIG prepared from the blood and blood components of donors previously showing evidence of infection would produce a more effective product.

In the proposed rule, we requested comments on continuing the requirement for testing each donation of blood and blood components for syphilis. We also requested data supporting their conclusion.

(Comment 28) The majority of comments that responded to the issue of testing for syphilis support eliminating such testing. These comments argue that there has been no reported case of transfusion transmitted syphilis in 30 years; that studies show treponemes don't survive in blood stored at 4 \1/2\ C and positive treponenemal DNA/RNA is not present in test positive donations based on studies using polymerase chain reaction (PCR ) (ARCNET study); that there are no relevant case reports of platelet transfusion transmission; and that recent studies indicate testing for syphilis has limited value as a surrogate marker for other communicable disease agents or high risk behavior. The comments also point out that syphilis testing has unnecessarily constricted the blood supply and eroded donor trust as otherwise qualified donors are deferred based on what turns out to be treated previous infection. Those comments that oppose eliminating the syphilis requirements criticize the recent ARCNET study's methodology and conclusions and argue that there is not sufficient information to eliminate testing requirements.

After reviewing the comments and submitted study in addition to other scientific data, we have determined that the comments did not provide sufficient supporting data to justify eliminating the requirements to test blood and blood components with a serological test for syphilis. Preliminary results from ongoing studies indicate that the infectivity of seroreactive donors remains the subject of scientific debate. (See the transcript of the 67th Blood Product Advisory Committee Meeting, September 15, 2000). We will continue to consider this issue including any further studies that address the issues of transfusion related syphilis infection or testing for syphilis as a surrogate marker for other communicable diseases. We remain interested in receiving data supporting the elimination of the requirement for syphilis testing. Blood and plasma establishments must continue to test donations of blood and blood components for syphilis under §§ 640.5(a), 640.14, 640.23(a), 640.33(a), 640.53(a), and 640.65(b)(2) and references to these sections are inserted into the codified language in §§ 610.40 and 610.41. The final rule requires that blood and plasma establishments defer donors who test reactive for a serologic test for syphilis unless a specific treponemal antibody test is negative or the donation is used for further manufacturing into control serum for a serological test for syphilis.

In § 610.40(h)(2)(vi) and (vii), we added language describing current requirements for the use of human blood, blood components, and Source Plasma with a reactive screening test for syphilis that is determined to be a biological false positive. Human blood and blood components may be used if the reactive screening test is further tested by an adequate and appropriate test demonstrating that the reactive screening test is a biological false positive. (See the list of documents in section IV of this document (dated December 12, 1991)). Such donations must be labeled with both test results. Source Plasma may be used from a donor with a reactive screening test for syphilis if the donor meets the requirements of § 640.65(b)(2).

This final rule becomes effective December 10, 2001. All blood and blood components collected on and after the effective date must be in compliance with the new requirements. Labeling required by §§ 610.40(c)(3)(ii) and (h)(2)(ii), and 610.42 must be submitted to FDA as part of a supplement submission requesting FDA approval prior to distribution of a product under § 601.12(f)(1) (21 601.12(f)(1)). All other labeling changes must be submitted in an annual report under § 601.12(f)(3).

FDA has examined the impacts of the rule under Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), and under the Unfunded Mandates Reform Act(2 U.S.C. 1501 et seq .). 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(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

The Office of Management and Budget (OMB) has determined that the rule is a significant regulatory action as defined by the Executive Order and so is subject to review. Because the rule does not impose any mandates on State, local, or tribal governments, or the private sector, that will result in any one year of $100 million or more, FDA is not required to perform a cost-benefit analysis according to the Unfunded Mandates Reform Act.

The Regulatory Flexibility Act requires agencies to prepare a Regulatory Flexibility Analysis for each rule unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Although the rule is not expected to have a significant economic impact on a substantial number of small business entities, a precise impact is uncertain. Therefore, the agency has prepared a Regulatory Flexibility Analysis.

The basis for this rule is to help protect the safety and ensure the quality of the Nation's blood supply, and to promote consistency in the industry. The safety of the Nation's blood supply is enhanced when donors whose test results indicate evidence of infection due to communicable disease agents are excluded from donating blood and blood components. Under the biologics licensing and quarantine provisions of sections 351-361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262-264) and the drug, device, and the general administrative provisions of sections 501-503, 505-519, and 701-704 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351-353, 355-360i, and 371-374), FDA has the authority to issue regulations designed to protect the public from unsafe or ineffective biological products and to issue regulations necessary to prevent the transmission of communicable diseases into the United States or from one State to another. Under these statutory authorities, the agency is: (1) Requiring supplemental (additional, more specific) testing of all donations that are reactive by screening tests for which there are supplementary tests; and (2) codifying as requirements those recommendations that FDA has issued that are necessary to ensure blood safety, including testing for evidence of infection due to HIV, HBV, HCV, and HTLV.

The rule requires that each donation of human blood or blood component, including those intended for use as a component of, or used to prepare, a medical device, but not including those intended for autologous use, unless shipped or used for allogeneic transfusion, be tested for evidence of infection due to HIV, types 1 and 2; HBV; HCV; and HTLV, types I and II. Each donation that is reactive when tested for evidence of infection due to any of the disease agents would be required to be further tested whenever a supplemental (additional, more specific) test has been approved for such use by FDA. FDA is requiring that the testing be done by a laboratory that is registered with FDA and CLIA-certified or meeting equivalent requirements as determined by HCFA. The rule also contains provisions for appropriate deferral of donors based on test results, and exemptions for Source Plasma from being tested for evidence of infection from HTLV, types I and II. Under the rule, allogeneic donations that test reactive shall not be shipped except in situations specifically approved by FDA. Autologous donations may be shipped as long as they are properly labeled.

This rule also requires manufacturers of tests kits, approved for use in testing donations of human blood and blood components for these disease agents, to verify an acceptable sensitivity and specificity of each lot of test kit, using a reference panel obtained from CBER or an FDA designated source, when available.

The testing of donations from allogeneic and certain autologous donors of blood and blood components will affect all blood and plasma establishments that collect blood and blood components from such donors. FDA's registration database has record of 981 registered blood establishments that collect blood and blood components and 60 licensed plasma centers with approximately 370 locations that collect Source Plasma. Whole Blood donors in the United States are volunteers. By contrast, most Source Plasma centers are commercial establishments with paid donors. Based on information published by the American Association of Blood Banks (AABB) regarding allogeneic donations (Ref. 1), and communications with experts in the blood banking industry regarding the testing of autologous donations, FDA believes that all of the 12 million blood donations (not including 643,000 autologous donations) currently collected annually by the regional and community blood centers and hospitals are already being tested for the specific disease agents as usual and customary business practice. FDA further estimates that autologous donations that are shipped are already being tested for HIV, types 1 and 2, HBV, HCV, HTLV, types I and II, and syphilis as usual and customary business practice. It is also usual and customary business practice for hospitals to solely use autologous donations for autologous use and not allow autologous donations to be used for allogeneic transfusion. Therefore, we estimate that since industry practices are currently the same as FDA requirements for testing shipped autologous donations, and are more stringent than FDA requirements for use of autologous donations for allogeneic transfusion, then additional costs to blood establishments collecting autologous blood and blood components will be minimal, if any.

In 1997, the Government Accounting Office (GAO) estimated that approximately 12 million donations of Source Plasma were collected by plasma centers (Ref. 2). Although the precise number of those donations currently tested for HIV, types 1 and 2, HBV, and HCV is not reported, FDA assumes that virtually all donations are currently being initially screened for the communicable disease agents specified for plasma donations in the rule. However, based on GAO reported variations in the plasma industry's confirmatory testing of repeat reactive donations, it is also assumed that supplemental testing for HCV is not widely practiced at present.

The requirements for lot testing of approved test kits by manufacturers will entail use of CBER regulatory reference panels to provide verification of the specificity and sensitivity of each lot of test kits approved for use in testing donations of human blood. This release criterion would be applied to lots of test kits produced by licensed manufacturers or lots produced by manufacturers pursuing licensure of such tests. FDA estimates that the number of manufacturers of kits for the four disease agents specified in the rule currently ranges from six to seven establishments per disease agent. It is also possible that some additional number of manufacturers may pursue licensure of such kits in future years, although the total number is likely to remain small because of the expected limits of demand for such tests.

FDA currently has reference panels available for all of the disease agents specified in the rule, and has made the panels available to all currently licensed manufacturers of test kits. To the agency's knowledge, all currently licensed manufacturers covered by the rule are already performing the tests to comply with their own quality assurance standards. The rule is therefore expected to introduce no substantial impact on these establishments.

The rule provisions for donation testing, appropriate handling, labeling, and distribution will involve a one-time effort by all blood and plasma establishments to review and modify current blood and plasma donor testing, handling, and recordkeeping protocols to comply with the rule. While the rule does establish test requirements, these are not expected to increase the yearly cost of donor screening testing.

The one-time effort to review and modify current SOP's is expected to take approximately 8 hours of staff time to reconcile the regulations against the facility's current standards. This process could be performed by a technical specialist who works as a regulatory reviewer or manager of quality assurance. Based on the total average hourly compensation of $25.67 for professional specialty and technical occupations in the health services industry, as reported by Bureau of Labor Statistics for March 1997, the cost would be approximately $205, for each of the blood and plasma collecting establishments. Because this final rule does not require that all blood centers test all autologous donations, it is a lesser burden that what was in the proposed rule. FDA assumes that the cost will be the same for all facilities, whether or not they currently test all autologous donations. It is also assumed that all facilities already perform careful labeling and keep records of test results for evidence of infection due to communicable disease agents. Thus, the total one-time cost for the industry is estimated to be $276,955 ((370 + 981 establishments) x $205).

(Comment 29) Ten comments asserted that testing of autologous donations is costly to facilities and patients.

We have considered these comments and we are limiting the requirement to test autologous donations to two occasions when risk of exposure is increased, i.e., when autologous donations are used for allogeneic transfusion or when they are shipped. It is assumed that there will be very little testing that was not already being done, and that the requirement to test autologous donations when used for allogeneic transfusion or shipped will not impose additional cost.

The rule also allows that multiple donations of blood and blood components from single donors dedicated to a single identified recipient be tested once at the beginning of a 30-day period. These dedicated donations, however, are relatively uncommon and are believed to generally undergo testing by all facilities that is at least as frequent as the rule requires.

(Comment 30) Two comments contend that supplemental testing should be required only for HIV and HBsAg. Four additional comments noted that supplemental testing is expensive.

The agency believes that while there are costs to supplemental testing, the costs imposed by this rule are mitigated because a substantial fraction of facilities already perform supplemental testing. In addition, the ability to obtain more precise information on donors testing reactive will improve public health by providing these donors with accurate health information.

Currently, blood and plasma establishments are required under § 610.46(b) to further test donations that test reactive by a screening test for HIV. Anti-HBc and anti-HTLV, types I and II, do not have supplemental (additional, more specific) tests approved for such use by FDA at this time. Therefore, the yearly increase in cost imposed by this final rule is based on the assumption that blood and plasma collecting establishments will need to begin supplemental (additional, more specific) testing on donations that test reactive for HCV and HBsAg. Assuming: (1) An average 0.18 percent (0.0018) rate of HCV reactive donations; (2) an average 0.05 percent (0.0005) rate of HBsAg reactive donations; and (3) an annual volume of approximately 24 million blood and plasma donations, and the cost for a supplemental (additional, more specific) test for HCV and HbsAg is approximately $144.50 and $8.00 respectively (Ref. 3), then the annual cost is estimated to be no greater than $5,946,400 ((24,000,000 x 0.0018) x $114.50 + (24,000,000 x 0.0005) x $8.00).

In summary, the rule would result in an estimated one-time cost of $276,955, and a total annual cost of $5,042,400 to the blood and plasma industries.

The rule is intended to increase the safety of all blood and blood component products by providing recipients with increased protection against communicable disease transmission. The rule addresses exposures that may occur through errors in administration of autologous as well as allogeneic blood units. For example, AABB Anonymous Survey Report included reports of erroneous transfusions (1.2 percent of respondents), untested recovered plasma salvaged (3.7 percent), units lost in transit (12.3 percent), units broken in the lab (33.6 percent), and units broken outside the lab (32.2 percent), as well as other errors (9.8 percent) (Ref. 4). The reduction in communicable disease risk already achieved among allogeneic blood transfusions as a result of infectious disease testing of donors has been quite dramatic. For example, as a result of the expansion of blood donor screening and improved laboratory tests, it is now estimated that the chances of transfusion-related HIV infection have decreased to between 1 in 450,000 to 660,000 per unit of blood (Ref. 5). HCV and HBV transfusion risks have also declined. In 1990, prior to specific testing, HCV was transmitted by 0.2 to 0.5 percent of transfusions, compared with the current rate of approximately 0.0005 percent. The risk of HBV transfusion transmission is currently estimated to be 1 in 500,000 transfused units.

The gravity of the disease risks addressed by the rule is widely recognized. Transfusion of HIV, the virus that causes AIDS, continues to cause great concern. Human T-cell leukemia/lymphoma viruses types I and II ,were identified in the early 1980's. Infection with the virus is associated with tropical spastic paraparesis, adult T-cell leukemia/lymphoma, and some inflammatory disorders (Lapane et al.). Although the virus is primarily transmitted by sexual contact and intravenous drug abuse, it can also be transmitted through blood transfusion.

HBV is a major cause of acute and chronic hepatitis, cirrhosis, and primary hepatocellular carcinoma worldwide. The Centers for Disease Control and Prevention (CDC) estimated that in 1985 approximately 300,000 persons became infected with HBV. Prior to the development of hepatitis screening tests, transfusion-related risks were significant. A retrospective testing of blood donors using first generation tests for the presence of HBsAg found that over half of recipients of HBsAg positive blood developed hepatitis (Ref. 6). Of the current pool of 1 to 1.25 million HBV carriers, approximately 25 percent will develop chronic hepatitis which will progress to cirrhosis and carriers will have a risk of liver cancer that is 12 to 300 times higher than the risk to non-carriers. An estimated 4,000 persons die each year from hepatitis B-related cirrhosis, and more than 800 die from primary hepatocellular carcinoma (PHC). The lifetime medical cost per case of PHC and cirrhosis is estimated to be $96,500 (Ref. 7).

Epidemiologic and experimental studies indicate that HCV is primarily transmitted by the parenteral route. Persons at increased risk of acquiring hepatitis C include parenteral drug users; health-care workers with occupational exposure to blood; hemodialysis patients; and recipients of Whole Blood, blood cellular components, or Plasma. Transfusion of blood or blood products, which accounted for a substantial proportion of HCV infections acquired more than 10 years ago, is now an uncommon means of transmission. CDC estimates that 150,000 to 170,000 new HCV infections occur annually in the United States (Ref. 8). Of patients with transfusion-associated chronic non-A, non-B hepatitis who undergo biopsy within 5 years after onset, at least 40 percent have histological evidence of chronic active hepatitis and 10 to 20 percent have evidence of cirrhosis (Ref. 9). An estimated 30 percent of those infected will eventually die of liver-related causes, an estimated 8,000 patients per year. Although some HCV patients have been found to respond to interferon therapy, the average cost of care per year for persons with liver disease from chronic hepatitis C is estimated to range from $24,600 for patients without interferon-alpha therapy to $26,500 per year for those receiving a 12-month course of therapy. The latter has been estimated to provide patients with an additional 0.37 quality-adjusted life years (Ref. 10). As described previously, the requirement of HIV, types 1 and 2; HBV; HCV; HTLV, types I and II; and syphilis testing for blood and blood component donations significantly reduces the U.S. population's exposure to the morbidity and mortality risks associated with these diseases, and their attendant costs.

The information available to characterize the relevant volumes of affected blood and plasma products is limited. Although the rule is not expected to have a significant impact on a substantial number of small entities, the impact on blood and plasma establishments that might qualify as small entities is uncertain. FDA has therefore prepared a Regulatory Flexibility Analysis. The blood and plasma establishments affected by the rule are included under the major Standard Industry Code (SIC) group 80 for providers of health services. According to section 601 of the Regulatory Flexibility Act of 1980, the term “small entity” encompasses the terms “small business,” “small organization,” and “small governmental jurisdiction.” “Small governmental jurisdiction” generally means governments of cities, counties, towns, townships, villages, school districts, or special districts with a population of less than 50,000.

The extent of the small business impact is uncertain. Although the details of blood collection at hospitals are not available, FDA examined other data to develop a preliminary assessment of small business impact. The size of U.S. hospitals varies substantially. The 1998 American Hospital Association (AHA) survey data (Ref. 11) indicate a total of 5,134 U.S. registered community hospitals grouped into 8 bedsize categories. The average annual revenues for facilities in these bedsize categories range from approximately $5.5 million to $513 million. However, since many hospitals are not-for-profit or are operated by State and local governments, the Small Business Association (SBA) annual receipts criteria for small businesses would not apply to these facilities. Of the 5,134 U.S. community hospitals included in the AHA report, 1,330 are under the control of State and local government, 3,045 are nonprofit institutions, and the remaining 759 are reported to be investor-owned. (Note that while there are over 5,000 community hospitals in this small entity impact analysis, not all 5,000 hospitals are collecting facilities. Therefore, this does not invalidate the estimate of 60 licensed plasma centers with 370 locations and 981 registered blood establishments affected by the rule.)

The number of hospitals that would meet at least one of the various SBA definitions for small entities is uncertain. According to the AHA statistics for 1998, the smallest reported hospital size category includes 262 hospitals with 6 to 24 beds, and total gross revenues of $1.43 billion, yielding average revenues of $5.46 million. FDA assumes that the 11 facilities reported to be investor-owned within this bedsize category could qualify as small entities. Although it is possible that all nonprofit hospitals may qualify as small entities, it appears that a number of facilities might be excluded from that definition because they are reported to be hospitals in a system. According to the AHA survey definition, “hospitals belonging to a corporate body that owns and/or manages health provider facilities or health-related subsidiaries; the system may also own non-health-related facilities.” The AHA currently has record of 1,592 hospitals that are nonFederal and nonprofit (including State and local government controlled) that are hospitals in a system. If these facilities were excluded, FDA estimates that 2,783 [1,330 State and local + 3,045 nonprofit—1,592 in-a-system] non-federal, nonprofit hospitals may qualify as small entities. Although, a total of 2,794 [2,783 + 11] hospitals might qualify as small entities, not all such hospitals collect blood and blood components, and some would be transfusion services only.

Approximately 75 of the 981 registered blood establishments that collect blood and blood components are responsible for collecting 65 percent of the blood supply (7.8 million donations). The remaining 906 registered blood establishments assumed to operate as small entities would collect 45 percent of the blood supply (5.4 million donations). If the estimated 5.4 million donations of blood and blood components were evenly distributed over the 906 registered blood collection establishments, each establishment would average 5,960 donations annually, of which approximately 11 (0.0018 x 5,960) might test reactive for HCV and approximately 3 (0.0005 x 5,960) of which might test reactive for HBsAg, and require supplemental testing. The expected cost of the additional testing would then be $1,283.50 (($114.50 x 11) + ($8.00 x 3)) per establishment per year.

The number of plasma facilities that would qualify as small entities is also uncertain. According to the General Accounting Office (Ref. 12) approximately 370 paid plasma collection locations annually collect about 12 million plasma donations, the vast majority of which is processed by 8 companies. FDA estimates that approximately 90 percent of these plasma collection locations are owned by companies that operate multiple facilities. Although the agency is uncertain about the level of revenues for these companies, it is considered likely that most would have annual receipts of $5 million or more per year. The remaining 10 percent of paid plasma collection locations (37 locations) may qualify as small business establishments. The potential impact on these facilities will be a function of the number of donors and the HCV and HBsAg reactive findings among donors at their facility. If the estimated 12 million plasma donations were evenly distributed over the collection centers, each center would average 25,000 donations. Assuming approximately 8 units per plasma donor per year (Ref. 12), each center would average 3,125 donors, approximately 6 (0.0018 x 3,125) of whom might test reactive for HCV and approximately 2 (0.0005 x 3,125) of whom might test reactive for HBsAg, and require supplemental testing. The expected cost of the additional testing would then be $703 (($114.50 x 6) + ($8.00 x 2)) per center per year.

In addition to these for-profit establishments, the remaining plasma collection centers function within blood collection centers that are operated by the American National Red Cross, or are independently operated. The independently operated, not-for-profit blood collection centers would likely qualify as small entities. The added impact of the rule on plasma collection performed at blood collection facilities is expected to be small, however, because the required testing would already be performed for Whole Blood donation.

FDA has considered alternatives for lessening the burden on small entities. The proposed rule proposed that all autologous blood be tested. By choosing this less costly alternative that does not require autologous blood testing, FDA is lessening the burden on small entities.

This final rule contains information collection requirements that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Recordkeeping and Reporting Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents.

Description: FDA is revising the test requirements in part 610 subpart E issued under the authorities of the act and the PHS Act. Section 610.40 of the final rule requires screening tests for evidence of infection due to communicable disease agents, HIV, types 1 and 2; HBV; HCV; HTLV, types I and II, be performed on each donation of human blood and blood component. Certain exceptions to performing screening tests are described elsewhere in this rule.

In § 610.40(c)(1)(ii), each dedicated donation must be labeled as required under § 606.121 and with a label entitled “INTENDED RECIPIENT INFORMATION LABEL” containing the name and identifying information of the recipient. Each donation that is untested in the 30-day period must be labeled “DONOR TESTED WITHIN THE LAST 30 DAYS.”

In § 610.40(d)(4), each autologous donation must be labeled as required under § 606.121 and with the following label, as appropriate. If the donation is: (1) Untested, label with “UNTESTED;” (2) negative, label as required under § 606.121; (3) reactive on the current collection or in the last 30 days, label with “BIOHAZARD” legend; and (4) tested negative within the last 30 days, label with “DONOR TESTED WITHIN THE LAST 30 DAYS.”

Under § 610.40(g), each donation that may be released or shipped prior to testing must be labeled as required under § 606.121(h) and the test results must be provided promptly to the consignee. Section 610.40(g)(1) permits release or shipment prior to completion of testing in documented medical emergencies, and § 610.40(g)(2) permits release or shipment prior to completion of testing when FDA provides written approval for the shipment or use.

In § 610.40(h)(2)(ii), human blood or blood components intended for further manufacturing use may be shipped or used under the following conditions.

• When FDA provides written approval for the shipment or use;

• When such human blood and blood components are labeled as required under § 606.121 or § 640.70 and with the “BIOHAZARD” legend;

• When such human blood and blood components are labeled reactive for the appropriate screening test for evidence of infection due to the identified communicable disease agent(s);

• When such human blood and blood components are intended for further manufacturing use into injectable products, and a statement indicating the exempted use specifically approved by FDA is included on the container label;

• When such human blood and blood components are intended solely as a component of, or used to prepare, a medical device and the statement “Caution: For Further Manufacturing Use As a Component of a Medical Device For Which There Are No Alternative Sources;” and

• When such human blood and blood components are intended for in vitro use and the statement “Caution: For Further Manufacturing Into In Vitro Diagnostic Reagents For Which There Are No Alternative Sources” is included.

In § 610.40(h)(2)(vi) and (h)(2)(vii), we added language describing current practice on the use of human blood and blood components, and Source Plasma, with a reactive screening test for syphilis that is determined to be a biological false positive.

In § 610.42(a), medical devices containing or used to prepare human blood or blood components that are reactive for syphilis or by a screening test for evidence of infection due to a communicable disease agent(s) must include, in addition to appropriate labeling requirements in subchapter H (Medical Devices), a statement of warning that the product was manufactured from a donation testing reactive for the identified communicable disease agent(s).

Description of Respondents: Establishments that collect blood and blood components.

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 they will make an assessment in light of public comments received on the proposed rule. No letters of comment on the information collection requirements were submitted to OMB or the docket.

Based on current information retrieved from FDA's registration data base, there are approximately 60 licensed plasma collection facilities and approximately 981 registered blood collection facilities for a total of 1,041 establishments. These facilities collect annually an estimated 24.6 million donations: 12 million donations of Source Plasma and 12.6 million donations of Whole Blood, including 643,000 autologous.

Section 610.40(c)(1)(ii) requires that each dedicated donation be labeled as required under § 606.121 (OMB No. 0910-0116) and with a label containing the name and identifying information of the recipient. FDA estimates that approximately 5 percent (10,250) of the 205,000 donations that are donated specifically for the use of an identified recipient would be tested under the dedicated donors testing provisions in § 610.40(c). FDA estimates that the remaining 95 percent would be tested as allogeneic donations in accordance with § 610.40(a), (b), and (e) because most such donors do not donate more often than once in a 30-day period, and because most establishments choose to test every donation. We estimate that each establishment expends approximately 5 minutes to insert the name of the recipient and identifying information on each label.

In § 610.40(g)(2) and (h)(2)(ii)(A), a manufacturer must obtain written approval from FDA when a manufacturer seeks to: (1) Ship human blood or blood components for further manufacturing use prior to completion of testing; or (2) ship human blood or blood components found to be reactive by a screening test for evidence of a communicable disease agent(s) or collect from a donor with a record of a reactive screening test, respectively. The only product currently shipped prior to completion of testing is a licensed product, Source Leukocytes, used in the manufacture of interferon, which requires rapid preparation from blood. Shipment of Source Leukocytes are preapproved under a product license application and each shipment does not have to be reported to the agency. To obtain approval from FDA as described in § 610.40(g)(2), we expect the manufacturer(s) to submit specific procedures for collection, shipment, and quarantine of a product before testing is completed, and the completion of testing as soon as possible after shipping. In addition, the manufacturer must promptly communicate the test results to the consignee. FDA has received two applications from the manufacturers of Source Leukocytes during fiscal year (FY) 95, FY 96, and FY 97. Therefore, we estimate receiving an average of two annually.

According to information from industry, a license application of this type would contain safety and effectiveness information and would take approximately 1,600 hours to prepare. The information that a manufacturer would need to put together for the request is typically part of an Biologics License Application (BLA) submission. Therefore, we estimate that approximately 1 hour of the estimated 1,600 hours would be used in preparing the request for FDA's approval to ship a product prior to completion of testing.

Under § 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), industry estimates that each manufacturer would ship an estimated 10 blood or blood components per month that would require 2 labels; one as reactive for the appropriate screening test under paragraph (C), and the other stating the exempted use specifically approved by FDA under paragraph (D). According to FDA's database, there are approximately 300 licensed manufacturers that ship known reactive blood or blood components. Industry also estimates that it would take approximately 10 minutes per blood or blood component to affix the labels.

In § 610.40(h)(2)(vi), each donation of human blood or blood component that tests reactive by a screening test for syphilis and is determined to be a biological false positive, must be labeled with both test results. After reviewing information from industry, we estimate that approximately 15,120 donations annually test reactive by a screening test for syphilis, and are determined to be biological false positives by additional testing. We also estimate that the establishment would expend approximately 5 minutes to label the blood or blood component with the results of both tests.

Section 610.42(a) requires a warning statement, including the identity of the communicable disease agent, on medical devices containing human blood or blood components found to be reactive by a screening test for evidence of infection due to a communicable disease agent(s) or syphilis. Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device, e.g., a positive control for an in vitro diagnostic testing kit. It is usual and customary business practice for manufacturers to include on the container label a warning statement that identifies the communicable disease agent. In addition, on the rare occasion when a human blood or blood component with a reactive screening test is the only component available for a medical device that does not require a reactive component, then a statement of warning is required to be affixed to the medical device. To account for this rare occasion we estimate that the warning statement would be necessary no more than once a year and we estimate the manufacturer would need to expend 1 hour to complete the labeling requirement.

Under § 610.40(g)(1), we are permitting in rare emergency circumstances, the release or shipment of human blood or blood components prior to the completion of testing for evidence of infection due to communicable disease agents. Such emergencies include, e.g., where a patient's need for blood is so acute as to preclude any communicable disease testing of the blood. We have concluded that the use of untested or incompletely tested blood in such medical emergencies should not be prohibited. Release of blood or blood components due to a medical emergency prior to completion of required testing must be appropriately documented. We estimate the recordkeeping to be minimal with one or less occurrence per year. Documentation of the medical emergency should take a half-hour or less. The reporting of test results to the consignee in § 610.40(g) does not create a new burden for respondents because it is the usual and customary business practice or procedure to finish the testing and provide the results to the manufacturer responsible for labeling the blood products.

Under section 1320.3(c)(2) of the PRA, the labeling requirements in § 610.40(c)(3)(ii), (d)(4), and (h)(2)(ii)(B) and (h)(2)(ii)(E) do not constitute collection of information because information required to be on the labeling is originally supplied by the Federal Government to the manufacturers for the purpose of disclosure to the public in order to keep the blood supply safe and protect public health.

The information collection provisions of this final rule have been submitted to OMB for review.

Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this 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 number.

The agency has determined under 21 CFR 25.30(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.

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.

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.

1. American Association of Blood Banks, Facts About Blood and Blood Banking, “http://www.aabb.org”.

2. General Accounting Office, “Blood Safety: Enhancing Safeguards Would Strengthen the Nation's Blood Supply,” GAO-HEHS-97-143, June 1997.

3. Lapane, K. L., A. F. Jakiche, D. Sugano, C. S. Wayne Weng, and W. D. Carey, “Hepatitis C Infection Risk Analysis: Who Should Be Screened? Comparison of Multiple Screening Strategies Based on the National Hepatitis Surveillance Program,” The American Journal of Gastroenterology , vol. 93, no. 4, pp. 591-596, 1998.

4. American Association of Blood Banks (AABB) Association Bulletin No. 95-4: AABB Position on Testing of Autologous Units. Attachment 1: AABB Anonymous Autologous Survey Request , May 9, 1999.

5. Podnos, Y. D. and R. A. Williams, Current Risks for Blood Borne Viral Illness in Blood Transfusion, Western Journal of Medicine , vol. 168, no. 1, pp. 36-37, January 1998.

6. Public Health Service Inter-Agency Guidelines for Screening Donors of Blood, Plasma, Organs, Tissues, and Semen for Evidence of Hepatitis B and Hepatitis C, Morbidity and Mortality Weekly Report 40 (RR-4) April 19, 1991.

7. Margolis, H. S., P. J. Coleman, R. E. Brown, E. E. Mast, S. H. Sheingold, and J. A. Arevalo, “Prevention of Hepatitis B Virus Transmission by Immunization: an Economic Analysis of Current Recommendations,” Journal of the American Medical Association , vol. 274, no. 15, October 1995.

8. U.S. Centers for Disease Control and Prevention, 1997, “www.cdc.gov/ncidod/diseases/hepatitis”.

9. Morbidity and Mortality Weekly Report , 40 (RR-4) April 19, 1991.

10. Kim, W. R., J. J. Peterucha, J. E. Hermans, T. M. Therneau, E. R. Dickson, R. W. Evans, and J. B. Gross, “Cost-Effectiveness of 6 and 12 Months of Interferon Therapy for Chronic Hepatitis C,” Annals of Internal Medicine , vol. 127, no. 10, November 1997.

11. Healthcare InfoSource, Inc., a subsidiary of the American Hospital Association, Hospital Statistics , 1998 ed., Chicago, IL.

12. General Accounting Office, “Blood Plasma Safety: Plasma Product Risks Are Low if Good Manufacturing Practices Are Followed.” GAO-HEHS-98-205, September 1998.

Blood.

Biologics, Labeling, Reporting and recordkeeping requirements.

Blood, Labeling, Reporting and recordkeeping requirements.

Labeling, Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 606, 607, 610, 640, 660, and 809 are amended as follows:

In the Federal Register of August 19, 1999 (64 FR 45355), we (FDA) proposed to require that blood and plasma establishments notify donors of their deferral due to results of tests for communicable disease agents or based on failure to satisfy donor suitability criteria. We issued the proposed rule with the intent of reducing the risk of transmission of communicable disease from the use of blood, blood components, and blood derivatives. Under the proposed rule, blood and plasma establishments would: (1) Notify the donors that they are deferred based on results of tests for evidence of infection due to a communicable disease agent or based on suitability criteria, and the reason for the deferral; (2) where applicable, provide the results of tests for evidence of infection due to a communicable disease agent(s) that was the basis for deferral, including the results of supplemental (additional, more specific) tests; (3) provide information concerning appropriate medical followup and counseling; (4) describe the types of donations the donors should not donate in the future; and (5) discuss the possibility that the donor may be found suitable in the future, where appropriate. We proposed that the notification process should include a minimum of three attempts to notify the donor and be completed within 8 weeks after the donor was determined to be deferred or at the first return visit of the donor, whichever is earlier. FDA provided 90 days for comments on the proposed rule.

In the same issue of the Federal Register of August 19, 1999 (64 FR 45340), we proposed to revise the general biological product standards by updating the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) testing requirements by adding testing requirements for hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by adding requirements for supplemental (i.e., additional, more specific) testing when a donation is found to be reactive for any of the required screening tests for evidence of infection due to communicable disease agents. (No change was proposed to the requirements for serological tests for syphilis). We also proposed regulations for the deferral of donors based on the results of the screening test. FDA provided 90 days for comment.

In the Federal Register of November 9, 1999 (64 FR 61045), we announced a public workshop to be held on November 22, 1999, and also extended to December 22, 1999, the comment period on both proposed rules, i.e., “Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents,” and “General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors.” The purpose of the public meeting was to provide a public forum for gathering information and views regarding the proposed rules.

We have written the final rule using plain language consistent with the Presidential memorandum on plain language in Government writing, dated June 1, 1998. We have adopted the plain language approach making the rule more accessible and understandable to the public. As a result, we have used pronouns in describing who must comply, e.g., “you” is used to refer to an establishment that collects blood or blood components. We also have used “must” instead of “shall.”

With this final rule, we created a new part 630 entitled “General Requirements for Blood, Blood Components, and Blood Derivatives” containing requirements for notification of deferred and unsuitable donors. Under § 630.6, establishments that collect blood or blood components must make reasonable attempts to notify all donors, including autologous donors, that they are deferred from further donations based on results of tests for evidence of infection due to communicable disease agents under part 610 or part 640 (21 CFR part 610 or part 640) in new § 610.41 or determined not to be suitable for donation based on failure to satisfy suitability criteria under § 640.3 or § 640.63. The establishment must provide the following information to the donor: (1) That the donor is deferred or determined not to be suitable for donation and the reason for that decision; (2) where appropriate, the types of donations of blood and blood components that the donor should not donate in the future; (3) where applicable, the results of tests for evidence of infection due to communicable disease agent(s) that were a basis for deferral, including results of supplemental (i.e., additional, more specific) tests; and (4) where appropriate, information concerning medical followup and counseling. The establishment must make reasonable attempts to notify the donor within 8 weeks of determining that the donor is deferred or determined not to be suitable for donation. The establishment must document that the donor has been successfully notified, or if unsuccessful, that the establishment made reasonable attempts to notify the donor. In addition to notifying an autologous donor, the establishment must notify the autologous donor's referring physician agents, with the same information and within the same time period, when the donor is deferred based on results of tests for evidence of infection due to communicable disease. Each establishment must prepare a SOP for donor notification and autologous donor referring physician notification, including the appropriate followup if the initial attempt at notification fails. Recordkeeping also is required.

This final rule on notification of donors is a companion rule to the final rule entitled “Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents” (testing final rule) found elsewhere in this issue of the Federal Register . The testing final rule revises the general biological product standards by updating the HBV and HIV testing requirements, by adding testing requirements for HCV and HTLV, and by adding requirements for supplemental (additional, more specific) testing when a donation is found to be reactive for any of the required screening tests for evidence of infection due to communicable disease agents. The testing final rule also requires the deferral of donors based on the results of screening tests for communicable disease agents, including syphilis. The requirements in the testing final rule are referenced throughout this document. Therefore, in order to understand fully the requirements of both rulemakings, they should be read together.

We received 14 letters of comment on the proposed rule, submitted by blood centers, hospitals, transfusion services, consumer advocacy groups, and professional associations. The comments predominantly supported the concept of promptly notifying donors that they are deferred based on results of tests for communicable disease agents or that they are determined not to be suitable for donation based on failure to satisfy suitability criteria. Some comments objected to FDA mandating how and when notification occurs. Others objected to specific requirements in the proposed rule. A summary of the comments and the agency's responses follow.

Proposed § 630.6(a) required an establishment that collects blood or blood components to notify donors who have been deferred based on results of tests for evidence of infection due to communicable disease agents or determined not to be suitable for donation based on failure to satisfy suitability criteria. In proposed § 630.6(b), the rule required the establishment to inform a donor that the donor is deferred or determined not to be suitable for donation and the reason for that decision. The establishment would also provide the following information: The types of donations of blood or blood components that the donor should not donate in the future; where applicable, the results of tests including supplemental (i.e., additional, more specific) tests; information concerning appropriate medical followup and counseling; and, where applicable, the possibility that the donor may be found suitable for future donations.

(Comment 1) Two comments suggested requiring notification of donors based on other criteria in addition to those deferred for results of tests for evidence of infection due to communicable disease agents and determined not to be suitable as a donor based on suitability criteria. One of the two comments suggested we require notification of donors deferred voluntarily by blood banks. The other comment argued that notification should apply to any preliminary test results carried out prior to blood or blood component collection.

Under the final rule, we are requiring notification of donors deferred based on results of required tests for evidence of infection due to communicable disease agents, or determined not to be suitable for donation due to failure to satisfy suitability requirements in §§ 640.3 and 640.63. The notification requirement is imposed in conjunction with requirements for testing for infection due to markers of certain communicable disease agents listed in new § 610.40 or for syphilis in §§ 640.5(a), 640.14, 640.23(a), 640.33(a), 640.53(a) and 640.65(b)(2), and for deferral of donors who test reactive for those markers in new § 610.41. The notification must include screening test results and the results of any approved supplemental (i.e., additional, more specific) tests. As we stated in the proposed rule, we are not requiring blood and plasma establishments to notify donors that are deferred voluntarily by blood and plasma establishments for a variety of medical reasons beyond what is required in the regulation. We believe notification of donors voluntarily deferred by a blood and plasma establishment should be left to the medical judgment of the blood or plasma establishment's medical director.

(Comment 2) Six comments argued that the proposed rule is too detailed on the method and content of notification. These comments argued that blood and plasma establishments need flexibility in how and what they tell donors about their deferred status. Further, the sensitivity of the information, the setting, and the donor's attitude may not lend themselves to the detailed notification included in the proposed rule. Several of the comments pointed out that most blood and plasma establishments follow the American Association of Blood Banks (AABB) standards and voluntarily notify donors, so FDA does not need to codify the details of notification.

The final rule provides blood and plasma establishments with the framework for notification of deferred donors and donors determined not to be suitable for donation. Donors who are deferred based on test results or determined not to be suitable for donation based on failure to satisfy donor suitability criteria must be informed that they are deferred or determined not to be suitable for donation and the reason for that decision. The donor must be given, where appropriate, a description of the types of donations the donor should not make in the future and information concerning medical followup and counseling. Where applicable, the donor must be provided the results of screening and supplemental tests for evidence of infection due to a communicable disease agent(s). In the final rule, our intent is not to remove from blood and plasma establishments the medical judgment necessary to inform donors fully of their potential infectious disease status. Rather, the final rule sets out the information the agency considers necessary to be provided to the donor. We recognize that some donors may need to be informed of the need for medical followup or counseling, others may not. A variety of factors may influence a blood and plasma establishment's decision to inform the donor in person, by phone, or by mail. The final rule is intended to help ensure consistency in the blood industry's notification practices. We believe uniform notification practices by blood and plasma establishments will improve blood safety by preventing donations by individuals at risk for transmitting communicable diseases.

(Comment 3) Five comments argued that the requirements of the proposed rule fall outside FDA's jurisdiction. These comments argued that donor notification and education don't affect the safety, purity, or potency of the blood supply because the donor is already deferred from future donations. The comments also argued that the manner of notification constitutes the practice of medicine best left to the discretion of the medical staff (or in the case of an autologous donor, the donor's referring physician) at the blood and plasma establishment, and should not be imposed on the collection site staff.

As we explained in the preamble of the proposed rule, notification of a donor is directly related to preventing the introduction and spread of communicable diseases. Through notification, a donor learns of the deferral and the need to refrain from future donations, as well as the medical significance of the deferral. Where appropriate, the donor is made aware of the need for further medical treatment or counseling. We do not agree that donor notification constitutes the practice of medicine. We believe that this information is pertinent to the donor's health status and that the donor must be made aware of such information in order to seek medical care as appropriate. Notification of donors is currently part of the AABB standards, which recommend that establishments notify donors of “any medically significant abnormality detected during the predonation evaluation or as a result of laboratory testing” (see section B3.500 of “AABB Standards for Blood Banks and Transfusion Services,” 19th edition, 1999). As many of the comments pointed out, this activity is currently performed as usual and customary business practice. The final rule also requires the establishment to develop SOP's for notifying donors and the referring physicians of autologous donors. A blood or plasma establishment that fails to comply with donor notification procedures is in violation of current good manufacturing practice (CGMP) and, therefore, is subject to the enforcement provisions of the Federal Food, Drug, and Cosmetic Act (the act).

(Comment 4) Two comments pointed out that several States have laws governing notification of donors and FDA's proposed requirements may conflict with State provisions and cause confusion for blood collection establishments.

We are aware of varying State requirements concerning notification of the State health authorities of a donor's positive test results, not of a donor's deferral. Such State laws require that the collecting establishment notify the State of certain communicable disease test results. The State may then notify the donor, but not always. Our requirements prescribe that the donor be notified directly of all test results that were the basis for deferral and be given information concerning medical followup and counseling. Our requirements are in addition to, and do not conflict with, State requirements.

(Comment 5) One comment supported providing donors with information about the possibility of requalification for donating and suggested expanding the requirement to include information regarding future donations even where there is no requalification process or method (algorithm) approved by FDA for such purpose. Two comments argued against notifying the donor of possible requalification. These comments argued that such information would make the notification too long and confusing and that blood and plasma establishments would be required to change their notification procedures every time requalification protocols change.

We have removed the requirement that blood and plasma establishments notify donors of the possibility that the donor may be found suitable for future donations. We removed this requirement because requalification of donors is not required and to explain the possibility of requalification to a donor would be an unnecessary burden for an establishment that does not have a requalification program. Under the related donor testing and deferral rule, blood and plasma establishments may use blood or blood components from a donor who was previously deferred as a result of testing reactive on a screening test(s) for specified communicable disease agent(s) if the blood or blood components currently test negative for those same disease agent(s) and the donor has been shown to be suitable to donate blood by an algorithm approved for that purpose by FDA. Blood and plasma establishments that requalify donors should consult FDA guidance on what to tell a donor about the possibility for future donation. Guidance documents may be obtained from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance documents may also be obtained by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by FAX by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. Persons with access to the Internet may connect to CBER at “http://www.fda.gov/cber/publications.htm.”

We proposed several exceptions to donor deferral in related rulemaking that would affect donor notification. Autologous donors testing reactive for communicable disease agents would not be deferred. Collecting establishments would not be required to notify autologous donors who test reactive for a communicable disease agent(s). Nevertheless, we recommended that collecting establishments notify autologous donors, when applicable, for the purpose of medical followup and counseling. We also requested comments on whether to require notification of autologous donors of reactive and supplemental test results even though such donors would not be deferred.

(Comment 6) Three comments supported permanently deferring autologous donors from future allogeneic donations and notifying the autologous donors of their deferral using the same criteria as for allogeneic donors. These comments argued that autologous donors and allogeneic donors present the same risks for future allogeneic donations. The comments also argued that notification of autologous donors will help reduce the spread of communicable disease, and help prevent potentially infectious autologous donors from attempting to become allogeneic donors in the future. One comment pointed out that notification of autologous donors of the results of infectious disease testing is widely practiced already and therefore would not be a burden on blood and plasma establishments.

Under new § 610.40 found elsewhere in this issue of the Federal Register , autologous donations must be tested for evidence of infection due to communicable disease agents only if the blood or plasma establishment ships autologous donations or maintains a program that allows autologous donations to be used for allogeneic transfusion. In such case, if an autologous donor tests reactive, he or she must be deferred from allogeneic donations under new § 610.41. In order to prevent donation in the future, deferral under new § 610.41 triggers the notification requirements of the final notification rule. Notification of autologous donors also must include the test results that are the basis for deferral, if applicable; types of donations they should not make in the future; and where applicable, information concerning medical followup and counseling. Recognizing that autologous donation is also a medically ordered procedure, blood and plasma establishments also must notify the deferred autologous donor's referring physician that the donor has been deferred based on test results and the reasons for that decision, including test results that are the basis for deferral and the types of donations the autologous donor should not donate in the future for allogeneic use.

An allogeneic donor completes a preliminary screening and physical assessment prior to donation. If the allogeneic donor is determined not to be suitable for donation during this process, it is usual and customary business practice that the donor be notified on site that they are determined not to be suitable for donation and given the reason for that decision. We anticipate that any additional required information will be provided at that time. However, usually when an autologous donor donates, it is by a physician's prescription and the autologous donor may not always meet, and is not required to meet, all the preliminary screening and physical assessment criteria. Even when the autologous donor is determined not to be suitable for allogeneic use, the donation is collected and labeled under § 606.121 and the autologous donor must be provided the information required in § 630.6(b), i.e., the reason for the determination; if applicable, types of donations they should not make in the future; and where applicable, information concerning medical followup and counseling.

(Comment 7) Six comments suggested that abnormal test results should be sent only to an autologous donor's referring physician, not the donor. The comments argued that an autologous donor is a patient under physician care undergoing a medical procedure ordered by that physician. Under these circumstances, the comments argued it would be appropriate to give the test results to the referring physician, similar to any other laboratory results, and let that physician determine the need to notify the donor for medical followup. These comments argued that notifying the autologous donor directly could interfere with the doctor-patient relationship and result in conflicting advice. Several comments state that notifying the donor's physician of test results is current industry practice. Two of the comments argued that there was no safety issue to justify notification of the autologous donor because reactive units would not enter the blood supply and few autologous donors return to donate allogeneic units.

Under the final rule, we are requiring blood and plasma establishments to notify both the autologous donor and the autologous donor's referring physician of the donor's deferral whenever the donor is deferred as required under new § 610.41. We believe that the referring physician needs to be informed of the reasons for the autologous donor's deferral due to test results. Such notification should include the results of any screening or supplemental tests so that the physician can make informed medical judgments about the donor as a patient. We also believe that the donor has a need to be informed of his or her deferral or determination not to be suitable, and the reasons for the decision, as well as any appropriate medical counseling or treatment. We believe notifying the deferred autologous donor is necessary both for the health of the donor and to help prevent deferred or unsuitable autologous donors from attempting future allogeneic donations if indicated. Autologous donors may wish to discuss the underlying reasons for the determination with their physicians.

In the proposed rule, blood and plasma establishments would be required to notify donors that they have been deferred from donations of Whole Blood, and transfusable components (including Plasma) only after they had tested reactive on a second occasion for anti-HTLV, types I and II, or anti-hepatitis B core (anti-HBc). The agency requested comments on whether to notify donors who test reactive for anti-HTLV, types I and II, or anti-HBc on only one occasion or to wait to notify donors upon testing reactive on the second occasion. Upon the availability of an approved supplemental (additional, more specific) test, a reactive donor would be deferred after a single reactive donation. At such time, blood establishments would notify donors of the test results of both the approved screening and supplemental tests.

(Comment 8) Four comments were submitted on the notification of donors testing reactive for anti-HTLV, types I and II, or anti-HBc. Two comments favored notifying the donor when the donor is deferred, i.e., after the reactive screening test on a second occasion. Another comment suggested notifying the donor after the reactive screening test on the first occasion, but not to defer until the reactive screening test occurs on a second occasion. One comment stated that the reliability of the tests for anti-HTLV, types I and II or anti-HBc is low enough that donor notification should not be required.

After reviewing the comments and further evaluation, we have decided to require blood establishments to notify donors who test reactive for anti-HTLV, types I and II, or anti-HBc on two occasions and, consequently, are deferred. Because an approved supplemental test for HTLV, types I and II, or anti-HBc is not currently available to aid in the notification, we believe it is appropriate that blood and plasma establishments not be required to notify donors after a reactive screening test on the first occasion due to the high rate of false reactivity in low risk blood bank settings. However, under new § 610.40(h)(1), the donation that tests reactive must not be shipped or used, and the donor remains in the donor pool until the donor tests reactive on a second occasion. It is our intent that if licensed supplemental tests for HTLV, types I and II, or anti-HBc are approved, blood establishments would be required to defer donors after a reactive donation on the first occasion regardless of the results of the supplemental (additional, more specific) tests and notify the donor of both the screening and supplemental test results as prescribed in § 630.6(b).

The proposed rule would require blood and plasma establishments to notify donors who are determined not to be suitable based on failure to satisfy donor suitability criteria.

(Comment 9) Five comments called for clarification of what suitability requirements would trigger notification of a donor determined not to be suitable for donation.

Currently, the regulations defining donor suitability in §§ 640.3 and 640.63 apply to all donations, including autologous donations. See comment 6 of this document for further discussion of notification of an autologous donor when determined not to be suitable for donation.

(Comment 10) Several comments argued that blood and plasma establishments already voluntarily notify donors based on failure to satisfy suitability criteria on site so the proposed rule is not necessary and too burdensome.

We believe that notification of donors based on failure to satisfy suitability requirements is necessary to help ensure consistency in industry practice and further improve the safety of the blood supply. We do not believe the final rule is too burdensome as it codifies what many blood and plasma establishments already are performing as usual and customary business practice. As the final rule discusses in section III.E of this document, notification of donors based on determination not to be suitable still may occur on site at the time of deferral.

(Comment 11) Two comments stated that criteria used in determining the donor not to be suitable for donation and notification of the donor are decided by medical professionals at blood and plasma establishments and constitute the practice of medicine. Consequently, the comments believed the proposed rule goes beyond FDA's jurisdiction.

We disagree with the comments. We believe that donor testing, deferral, and notification are within our jurisdiction because they relate to the safety of blood products and the control of communicable disease. We believe the deferral and notification requirements will help ensure that the Nation's blood supply is safe by excluding donors who may present significant risks from donation in the future. These requirements also will enhance the public health by helping to ensure that those donors who have been deferred or determined not to be suitable for donation are advised to seek treatment and counseling, where appropriate.

(Comment 12) One comment argued that requiring blood and plasma establishments to notify donors based on their failure to satisfy suitability criteria under the proposed rule may create a patient-physician relationship between the donor and the blood and plasma establishment, therefore violating statutes that prohibit the corporate practice of medicine.

We disagree with the comment. Our intention is not to encourage the practice of medicine by the blood and plasma establishments, but to help ensure that blood and plasma establishments help prevent the potential spread of communicable disease and provide valuable information that may affect the donor's health so that the donor can seek medical care as appropriate. We have revised the language in § 630.6(b) of the final rule to support these intentions.

(Comment 13) Two comments argued that notification of a donor based on failure to meet suitability criteria is done on site at the time of donation, so blood and plasma establishments should not be required to make three attempts at notification at some later date.

The final rule is not prescribing the method of notification to be used. This will allow the blood and plasma establishments to determine the best method of notification for a particular donor. This flexibility allows a collecting establishment to notify the donor on site either at the time of the donor's screening and physical assessment or at the time of the donor's return visit, by phone, or by mail.

The final rule requires that the blood or plasma establishment make reasonable attempts to notify donors. For example, an establishment may send a notification letter by regular mail to a donor in compliance with § 630.6. A week later, the letter is returned to the establishment by the post office marked “address unknown.” The establishment could then proceed with the additional steps until successful notification occurs, or until it is clear that further attempts will not be successful. Such steps could include: Checking the record of the donor's address for transcription error; or searching a local phone book for a correct address and then, in either case, resending the letter. Additionally, the establishment could phone the donor and either notify the donor at that time or ask for a correct address in order to resend the letter.

The final rule also clarifies that a blood or plasma establishment must make reasonable attempts to notify the donor within 8 weeks after determining the donor is deferred or not suitable until the establishment actually succeeds in notification or until the blood and plasma establishment makes sufficient reasonable attempts at notification and it is clear that further attempts will not be successful. A blood and plasma establishment that successfully notifies on site at the time of donation would not have to notify further a donor determined not to be suitable for donation based on failure to satisfy suitability criteria under §§ 630.6 and 640.63.

(Comment 14) One comment argued that blood and plasma establishments should be allowed to notify donors determined not to be suitable for donation based on failure to satisfy suitability criteria by providing the donors with generic letters on site.

The final rule does not prohibit this method of notification as long as a blood or plasma establishment can fully meet the requirements of §§ 630.6 and 630.63 by including the necessary information in a standardized letter. However, blood and plasma establishments may need to supplement such a letter on a case-by-case basis with information specific to the donor.

(Comment 15) Two comments pointed out that many donors determined not to be suitable for donation based on failure to satisfy suitability criteria do not need further treatment or counseling.

We agree with the comment. In the final rule, we clarify the intent to require blood and plasma establishments to provide donors, deferred or determined not to be suitable for donation, with information concerning medical followup, treatment or counseling only when applicable to a particular donor. We recognize that for some donors referral to medical followup or counseling would be unnecessary.

(Comment 16) One comment argued that the proposed rule should not treat donors deferred based on test results in the same manner as donors determined not to be suitable for donation based on failure to satisfy suitability criteria because the former have known health problems while the latter probably do not.

We disagree with the comment. Both reactive test results for communicable disease agents and failure to satisfy suitability criteria raise health concerns for the donor of which the donor should be aware. However, the information provided in the notification may vary, depending on the reason for the deferral or determination not to be suitable for donation based on failure to satisfy suitability criteria.

The preamble of the proposed rule discussed the possibility that blood and plasma establishments would be able to fulfill the notification requirements on site. It explained that some blood and plasma establishments may notify donors by registered mail, return receipt; or may choose to request that the donor return for direct donor notification. In the preamble of the proposed rule, FDA requested comments on the methods of notification that would help ensure adequate donor confidentiality and the current application and sufficiency of Federal, State, and local laws that protect the privacy of the individual being notified.

(Comment 17) Four comments argued that blood and plasma establishments should have flexibility in the manner they meet their notification obligations under § 630.6(b) and in the way they protect donor confidentiality. No comments were received on the current application and sufficiency of the Federal, State, and local laws that protect the privacy of the individual being notified.

Under the final rule, blood and plasma establishments have the flexibility to choose the manner in which they notify donors. Provided that their notification obligations are fulfilled within 8 weeks, blood and plasma establishments may choose to notify a donor: (1) In person at the time of actual deferral, (2) in person at the donor's first return visit, (3) by phone, or (4) by mail.

Personnel performing this activity must be adequately trained as required under § 606.20. One method of notification that helps ensure donor confidentiality is person-to-person contact.

(Comment 18) Seven comments objected to FDA requiring that notification be sent by registered mail. These comments argued that some donors will not open registered mail and others will be unnecessarily alarmed by receipt of such a letter. The comments stated that sending notification by certified mail will not guarantee that the donor receives it and will add significant expense unnecessarily. The comments suggested that a letter sent by regular mail, documented by the blood or plasma establishment, should be sufficient.

The preamble of the proposed rule only discussed the possibility of notification by certified mail. Blood and plasma establishments may fulfill their notification obligations by regular mail provided they do so within 8 weeks after determining that the donor is deferred or is not suitable to donate and they document their notification attempts.

(Comment 19) Two comments asked for FDA to allow notification of a donor by telephone or by letter providing a telephone number that the donor can call for information regarding the deferral.

The final rule does not preclude notification by telephone provided a blood or plasma establishment meets all of its notification obligations under § 630.6 and documents notification of the donor.

(Comment 20) Five comments objected to FDA requiring blood and plasma establishments to make three attempts to notify donors deferred based on results of tests for communicable disease agents or determined not to be suitable for donation based on failure to satisfy suitability criteria. These comments argued that the first attempt should be sufficient because it is made shortly after the donation and subsequent attempts are unlikely to succeed.

We clarify in the final rule that a blood or plasma establishment must make reasonable attempts to notify the donor. We eliminate the requirement for three attempts to emphasize that a blood or plasma establishment should continue attempting to notify a donor until it is clear that further attempts would not be successful. If the initial attempt or attempts are unsuccessful, a blood or plasma establishment may need to try other methods to contact the donor. If a blood or plasma establishment is successful in notifying a donor then, obviously, no other attempts are necessary. Blood and plasma establishments must document their attempts to notify donors and maintain a record of these attempts, whether successful or not.

(Comment 21) One comment suggested 8 weeks is not enough time for blood and plasma establishments to complete notification because some confirmatory test results take longer to be completed. Another comment argued that 8 weeks is too long a timeframe for notification.

We believe blood and plasma establishments will be able to complete notification or reasonable attempts to notify the donor within the prescribed 8-week timeframe. Blood and plasma establishments must attempt to obtain the results of supplemental tests prior to notifying donors of their deferral. However, if the results were unavailable prior to notification, blood and plasma establishments would be required to renotify the donor with the results of the supplemental testing. We believe that the results of tests for communicable disease agents, including approved supplemental tests, should generally be available within the 8-week notification timeframe.

In proposed § 606.160(b)(1)(x), FDA proposed to require the blood or plasma establishment to record the donor's permanent address to facilitate the notification of the donor.

(Comment 22) Five comments objected to FDA requiring proof of a permanent fixed address. These comments question what proof of a permanent, fixed address would be acceptable and point out that certain donors may not be able to provide such proof. The comments argued it is not logical that voluntary donors would misrepresent their address. Several of these comments point out that donors may have privacy concerns for not giving a permanent address.

We clarify in the final rule that blood and plasma establishments need to obtain and keep a record of an address where the donor represents he or she can be reached within 8 weeks after donation. A donor does not need to prove that the provided current address is fixed or permanent.

FDA has examined the impacts of the rule under Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), and under the Unfunded Mandates Reform Act (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(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

The Office of Management and Budget (OMB) has determined that this rule is a significant regulatory action as defined by the Executive Order and so is subject to review. Because the rule does not impose any mandates on State, local, or tribal governments, or the private sector, that will result in an expenditure in any one year of $100 million or more, FDA is not required to perform a cost-benefit analysis according to the Unfunded Mandates Reform Act.

The Regulatory Flexibility Act requires agencies to prepare a Regulatory Flexibility Analysis for each rule unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. As explained in the following sections of this document, the rule is not expected to have a significant economic impact on a substantial number of small business entities because donor notification is considered usual and customary business practice for the affected entities.

As discussed previously, FDA is implementing this action to help protect the public health and promote consistency in the industry. The safety of the Nation's blood supply is enhanced when donors whose test results indicate evidence of infection due to communicable disease agents or who fail to satisfy suitability criteria are excluded from donating blood and blood components. Once donors are deferred from donation or determined not to be suitable for donation, they would be informed of the deferral or determination and the reason for that decision; the types of donations they should not donate in the future; the screening and supplemental test results, if applicable; and information concerning medical counseling or treatment, as appropriate. Public health would be protected not only by deferring the donor from future donations and preventing the transmission of communicable disease agents through transfusion, but also by counseling the donor to minimize the risk of transmitting the disease agent.

This action is taken under the authority of sections 351 and 361 of the Public Health Service Act (42 U.S.C. 262 and 264 et seq .) and the provisions of the act that apply to drugs, specifically section 501 of the act (21 U.S.C. 351), in order to prevent the introduction, transmission, and spread of communicable disease, and to ensure that methods used in manufacturing conform with CGMP's. Failure to comply with donor notification procedures would violate CGMP's and, therefore, the blood or plasma establishment would be subject to the act's enforcement provisions. FDA has reviewed related Federal rules and has not identified any rules that duplicate, overlap, or conflict with the rule.

The rule requires that blood and plasma establishments notify donors, including autologous donors, of their deferral because of the results of testing for evidence of infection due to communicable disease agents including HIV, HTLV, hepatitis B, hepatitis C, or syphilis or that they are determined not to be suitable for donation based on failure to satisfy suitability criteria. Blood establishments also are required to notify referring physicians of autologous donors of reactive test results for evidence of infection due to communicable disease agents. Under the rule, the donor must be notified of the types of blood or blood components that the donor should not donate in the future, where appropriate. The notification must include the results of tests for evidence of infection due to communicable disease agents including the results of supplemental tests, if applicable, and where appropriate, the types of donation of blood or blood components that the donor should not donate in the future, and information concerning medical followup and counseling. The establishments must make reasonable attempts to notify the donor within 8 weeks of the donor deferral or determination not to be suitable for donation. In order to implement this notification process, the rule also requires that blood and plasma establishments obtain and record an address for each prospective donor. Establishments must also maintain records of attempts to notify a deferred or unsuitable donor within the prescribed timeframe. An establishment also must prepare SOP's describing all steps required in the notification process.

The donor notification requirements will affect all blood and plasma establishments that collect blood and blood components. FDA's registration data base for blood and plasma establishments has record of approximately 1,041 establishments: 60 licensed plasma establishments with multiple locations and 981 registered blood establishments. The AABB estimates that approximately 12.6 million blood donations are collected annually. Allogeneic blood donations have recently accounted for an estimated 87.2 percent of that total with autologous donations comprising an additional 8.1 percent and directed donations averaging 3.2 percent (Ref. 1). In 1997, the General Accounting Office (GAO) estimated that approximately 12 million donations of Source Plasma were collected by plasma centers.

The rule is expected to have a minor net impact on blood and plasma establishments because it is already usual and customary business practice in the blood industry to notify donors that are deferred or determined not to be suitable for donation; virtually all establishments include this process within current operational guidelines. FDA expects that the primary impact of the rule will include a one-time review effort at each facility and a more extensive notification process at those facilities that currently perform donor notification over a longer timeframe or with fewer notification attempts. The agency received one letter of comment on the estimated one-time burden on the blood and plasma establishments in complying with the requirements of the rule.

(Comment 23) One comment asserted that the review of the regulation alone would require at least 4 hours of staff time to comprehensively understand the directives. Another comment in the letter asserted that revisions to procedures could not be accomplished in only 4 hours, noting that notification letters and computer software would have to be revised, staff would have to be trained, and there may be a need to purchase new equipment such as printers.

FDA agrees that the estimated time of 4 hours did not adequately account for time spent for revising the establishment's SOP's in addition to reviewing the regulations. Therefore, we are revising the estimated time for review of the regulation and revision of an establishment's SOP's to 8 hours for those establishments that currently maintain donor records and have notification procedures in place similar to those required by this rule. FDA agrees that establishments that make substantial changes to their notification processes (such as the information contained in their notification letters) will require more time. The agency assumes such facilities will require 24 hours of staff time and FDA uses this assumption in its cost models. FDA does not believe this donor notification rule requires a capital investment in new equipment.

The one-time effort to review and modify current SOP's is expected to vary among the 1,041 establishments, depending on the extensiveness of a facility's current protocols for donor notification. For establishments that already keep required donor information and perform the level of notification effort specified by the rule, FDA estimates that it would take approximately 8 hours of staff time to reconcile the regulations against the facility's current standards. A technical specialist who acts as a regulatory reviewer or manager of quality assurance could perform this process. Based on the total average hourly compensation of $25.67 for professional specialty and technical occupations in the health services industry, as reported by the Bureau of Labor Statistics for March 1997, the cost would be approximately $205 per establishment. For establishments that already perform donor notification but provide different information to donors or have established a different notification process than specified in the rule, FDA assumes that approximately 24 hours of staff time would be required to align current SOP's and recordkeeping with the provisions of the rule. The cost in this case would be approximately $616 per establishment. FDA does not have the data to estimate the percentage of facilities that will require a minimal effort versus a more involved review of SOP's; however, it is expected that many facilities have SOP's and recordkeeping standards that are consistent with the rule. Assuming a minimal review is needed at two-thirds of the 1,041 currently operating establishments, and a more extensive review is conducted by the other one-third, the total one-time cost for the blood and plasma industries is estimated to be $356,022 ((2/3 x 1,041 x $205)) + (1/3 x 1,041 x $616)).

The yearly increase in cost is based on the ongoing notification of donors. FDA assumes that all donors determined not to be suitable for donation based on the screening interview can be notified onsite at the time of the determination, and provided with the appropriate information. FDA assumes that this will introduce no new costs for the blood and plasma establishments. The cost of notifying donors deferred on the basis of blood test findings is based on the following numbers: (1) A proportional extrapolation of the number of donors who would test repeatedly reactive for evidence of infection in tests for HIV, HTLV, HBV, or HCV (a prevalence rate of 121.9 per 100,000 for viral markers among prospective donors) (Ref. 2); (2) that approximately 80 percent of donations are made by repeat donors 1 (12.6 million x .80 = 10.08 million blood donations and 12 million x .80 = 9.6 million plasma donations); (3) that repeat donors average two donated units per year 2 (10.08 million/2 = 5.04 million blood donors and 9.6 million/2 = 4.8 million plasma donors); and (4) that the first time donors contribute one unit per year (12.6 million—10.08 million = 2.52 million blood donors and 12 million—9.6 million = 2.4 million plasma donors). As a result, an estimated 9,264 deferred blood donors and 8,777 deferred plasma donors (including first time and repeat donors) would be notified each year, or a total of 18,041 annual notifications.

FDA assumes that all facilities currently make at least one notification attempt for all donors deferred based on test results. However, the percentage of facilities that would attempt notification more than once within an 8-week period is not known. FDA has therefore estimated the economic impact for a scenario in which the cost of compliance is based on the assumption that in one-fourth of the 18,041 notifications or 4,510, two additional notification attempts are needed, a phone call and a letter once the address has been corrected for a transcription error. This estimate is conservative and likely overstates the true frequency. The cost for these two notifications are estimated to be the cost of 0.5 hours of staff time for the phone call or $12.84, and 0.25 hours per staff time and 33 cents for the mailing or $6.75, for a total cost of approximately $19.59. The cost of compliance would be $181,482 [9,264 x $19.59] for the blood industry, and an estimated $171,941 [8,777 x $19.59] for the plasma industry. Because autologous donations constitute approximately 8 percent of all donations and these donations are referred by physicians, the rule requires establishments to send notifications to both the autologous donor and the referring physician. FDA estimates that the blood industry would incur an additional cost of $14,519 [$181,482 x .08], for a total of $196,001.

As described in the preamble to this rule, notification of donors that they have been deferred or determined not to be suitable and consequently should not attempt subsequent donations will help prevent unsafe units of blood or blood components from entering the blood supply. Notified donors can then self-defer in the future and help protect the Nation's blood supply. In & FDA's proposed rule on donor testing (64 FR 45340, August 19, 1999), the agency provides an extensive discussion of the benefits of reducing public exposure to the risks of these infectious diseases. FDA refers the reader to this discussion of the significant public health benefits of minimizing patients' risk of being unwittingly exposed to infection with HIV, HTLV, hepatitis B, and hepatitis C.

The rule is not expected to have a significant impact on a substantial number of small entities, however, the impact on blood and plasma establishments that qualify as small entities is uncertain. FDA has therefore prepared a regulatory flexibility analysis. The blood and plasma establishments affected by the rule are included under the major standard industrial classification (SIC) code major group 80 for providers of health services. 3 According to section 601 of the Regulatory Flexibility Act of 1980, the term “small entity” encompasses the terms “small business,” “small organization,” and “small governmental jurisdiction.” According to the Small Business Administration (SBA), a “small business” within the blood industry is an enterprise with less than $5 million in annual receipts. A “small organization” is a not-for-profit enterprise which is independently owned and operated and is not dominant in the field. A “small government jurisdiction” generally means government of cities, counties, town, townships, villages, school districts, or special districts, with a population of less than 50,000. 4

As noted in the foregoing analysis, the rule is expected to have some cost impact on both plasma and blood collection centers. FDA has record of a total of 60 licensed plasma centers with multiple locations. FDA estimates that the vast majority of the plasma is processed by eight companies and that these companies own 90 percent of the plasma centers. FDA assumes that the other 52 plasma centers not associated with the eight companies may qualify as small business establishments. FDA has estimated that only 10 percent of plasma locations are owned by the 52 small entities. The potential impact on plasma collection facilities will be a function of the number of donors and the viral marker rates at their facility. The net impact on these facilities, however, is expected to be minor. If the estimated additional yearly cost of $171,941 was spread evenly over all locations, then the yearly cost to all 52 small entities would be $17,194 [$171,941 x 0.10], or approximately $331 [$17,941 / 52] per small entity per year.

The impact on blood collection facilities that qualify as small entities is also uncertain, although it is not expected to be significant. The blood collection facilities that are independent and not-for-profit organization may qualify as small entities regardless of the size of their operations. The analysis that follows, however, considers the smaller blood collection facilities, because they are expected to experience the greater cost impact.

According to the 1996 directory of the AABB, 34 regional and community blood centers have annual revenues of less than $5 million; and each collect no more than 30,000 donations per year. Because of the pre-existing practice of donor notification at these facilities, and the relatively small number of donors that FDA estimates will be notified based on blood test findings, the impact on these small facilities is expected to be minor. Based on FDA's calculations, the 34 facilities with 30,000 donations or fewer per year, would identify an estimated 37 deferred donors per year through blood testing (30,000/100,000 x 121.9 = 37). If these facilities currently need to make two additional notification attempts under this rule, there would be an average small facility notification cost of $724 (37 x $19.59) per year. Because the estimated one-time cost for the review and revision of current deferral notification SOP's averages $342 (2/3 x $205 + 1/3 x $616) per establishment, the average annualized cost impact for the smaller collection establishments would be about $1,066 ($724 + $342), or roughly $0.04 per donation, assuming approximately 30,000 donations per year.

The types of professional staff and skills required to perform the required tasks are described in section III.E of this document. FDA is confident that the tasks specified in the rule can be readily performed by the type of staff already employed at affected blood and plasma establishments.

To minimize the impact on small entities while continuing to protect public health, the agency does not require donor notification until after the results of the approved supplemental testing are available.

As an alternative to this rule, FDA considered not requiring donor notification of deferral from future donation due to communicable disease testing or failure to satisfy suitability criteria because it is viewed by many as medical practice. However, the agency has rejected this alternative for the following reason. After a lengthy period of time during which the agency issued recommendations to establishments on notifying donors of deferral, the establishments have provided the deferred donor with inconsistent information and counseling. Notification of donor deferral has become a public health issue because donors who are not fully informed of their deferral status due to communicable disease testing or failure to meet suitability criteria may not take precautions to minimize the transmission of communicable disease to others and may not recognize the importance of not attempting to donate blood or blood components in the future.

In the proposed version of this rule, the agency considered making the notification of reactive autologous donors recommended, but not mandatory, and that these donors not be deferred. In the final rule, the agency is requiring that reactive autologous donors, and their referring physicians, be notified and that these donors be deferred. The agency believes that that notification of autologous donors and their referring physicians will generate many of the same benefits as notification of allogeneic donors.

This final rule contains information collection requirements that are subject to review by the OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification.

Description: This final rule amends §§ 606.100(b)(20) (Standard Operating Procedures), and 606.160(b)(1)(ix to xi) (Records), and adds new part 630 (Donor Notification), all of which contain new information collection.

Section 606.100(b)(20), requires blood and plasma establishments to write, maintain, and follow SOP's for donor deferral, donor notification, including autologous donors, and notification of referring physicians of autologous donors. This provision also requires SOP's for appropriate followup if the initial attempt at notification fails.

Under § 606.160(b)(1)(ix) and (b)(1)(xi) establishments must maintain records of each notification and notification attempts of allogeneic donors, autologous donors, and the referring physicians of autologous donors. Section 606.160(b)(1)(x) requires establishments to record where the donor may be contacted within 8 weeks of donation.

Section 630.6(a) requires establishments collecting blood or blood components to make reasonable attempts to notify donors, including autologous donors, who are deferred based on the results of tests for evidence of infection due to a communicable disease agent(s) including syphilis; or determined not to be suitable for donation based on failure to satisfy suitability criteria. Section 630.6(b) requires that notification contain the following information: (1) The donor is deferred or determined not to be suitable for donation, and the reason for that decision; (2) the types of blood or blood components the donor should not donate in the future, where appropriate; (3) the establishment must provide the results of the test for evidence of infection due to the communicable disease agent(s) including syphilis that was the basis for the deferral and results of supplemental (additional, more specific) tests, when applicable; and (4) where appropriate, the establishment must provide information concerning medical followup and counseling.

Under § 630.6(d)(1), the establishment must notify the referring physician of an autologous donor when the autologous donor is deferred under new § 610.41. This notification must provide the same information as required for the notification of a donor.

Description of Respondents: Blood and plasma establishments that collect blood, and blood components, including Source Plasma.

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 45355). In accordance with the PRA, OMB reserved approval of the information collection burden in the proposed rule stating that they will make an assessment in light of public comments received on the proposed rule. Two letters of comment on the information collection burden were submitted to the docket.

(Comment 24) One comment, in response to our notification estimate of a half hour, stated that notification and providing the required information would more likely take at least 1 hour, especially for individuals apparently infected with HIV, HBV, or HCV. The comment also stated that providing followup testing (supplemental) is more likely to take at least half an hour.

FDA agrees with the comment and is revising the estimated hours per response in table 1 of this document to 1.5 hours for notifying a donor with reactive screening test results.

(Comment 25) One comment suggested that the burden of the recordkeeping requirements for documenting the attempts to contact the donor is significantly underestimated.

The comment did not provide information supporting the statement that the burden is underestimated. Therefore, we continue to estimate the time for recording the notification of each donor as an average of 3 minutes. (Comment 26) One comment opined that the estimate of 1.2 percent for donors who are deferred from donating due to failure to satisfy suitability criteria is far below actuality and that the number of donors deferred as a result of health history questions average 13 percent.

We have revised our estimate to reflect that an average of 13 percent of donors annually are determined not to be suitable for donation based on failure to satisfy suitability criteria.

According to FDA's registration data base, there are currently about 1,041 establishments affected by this rule: Approximately 60 licensed plasma establishments with multiple locations that collect Source Plasma, and approximately 981 registered blood and plasma establishments that collect blood and blood components. The number differs from the number of respondents estimated in the proposed rule (2,800) because we incorrectly included in the estimated number all registered establishments, including those that do no collect blood and plasma. Based on estimates provided by AABB and GAO, these establishments collect annually approximately 12.6 million donations of blood and blood components from approximately 8 million donors and approximately 12 million donations of Source Plasma from 1.5 million donors. As part of the 12.6 million donations of blood and blood components, AABB also estimates that approximately 643,000 autologous donations are collected annually. Assuming each autologous donor makes an average of 2 donations, we estimate that there are approximately 321,500 autologous donors.

Industry estimates that approximately 13 percent of 9.5 million donors (1.2 million donors) who come to donate annually are determined not to be suitable for donation prior to collection because of failure to satisfy suitability criteria. It is the usual and customary business practice of virtually all 1,041 collecting establishments to notify on site and to explain the reason why the donor is determined not to be suitable for donating. Based on such information as is available to FDA, we estimate that two-thirds of collecting establishments (697) provide on site additional information and counseling to a donor determined not to be suitable for donation as usual and customary business practice. Consequently, we estimate that only one-third or 344 collection establishments would need to provide additional information and counseling on site to 400,000 total donors. Industry representatives estimated that it takes on average approximately 5 minutes to provide appropriate health information to a donor determined not to be suitable for donation.

GAO estimates that another 4.5 percent of 9.5 million donors (427,500 donors) are deferred annually based on test results. We estimate that currently 95 percent of the establishments that collect 98 percent of the blood and blood components notify donors who have reactive test results for HIV, HBV, HCV, HTLV, and syphilis as usual and customary business practice. Consequently, 5 percent (52) of the industry collecting 2 percent (8,550) of the deferred donors would experience new burden related to this requirement. We have adjusted our original estimate of 15 minutes to complete the notification process to 1 hour based on comment from industry. Based on the same comment, we have also adjusted the time estimated for additional counseling of the donor once notification is received from 15 minutes to 30 minutes. The total for notification of each donor is 1.5 hours. As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process. However, we estimate that 5 percent of the 981 blood collection establishments (52) do not notify the referring physicians of the estimated 2 percent of 321,500 autologous donors with reactive test results (6,430). The time for these establishments to notify the referring physician is estimated at 1 hour.

We estimate that 1,041 establishments will each expend, as a one-time burden, an average of 8 hours to reconcile their SOP's with the requirements (one-time burden of 7 hours to revise and an on-going burden of 1 hour to maintain). All plasma and blood establishments record each donor's address as part of their usual and customary business practice and, therefore, the requirement under § 606.160(b)(1)(x) does not create new or additional burden. Section 606.160(b)(1)(ix) requires that establishments record the notification efforts. We estimate that it will take 3 minutes on average to record the notification status of each of the 1.2 million donors determined not to be suitable to donate and each of the 427,500 donors deferred based on reactive test results for evidence of infection due to communicable disease agents. Section 606.160(b)(1)(xi) requires that records be kept regarding an establishment's efforts to notify the referring physician of a deferred autologous donor. Only the 981 registered blood establishments collect autologous donations and therefore are required to notify referring physicians. We estimate that 4.5 percent of the 321,500 autologous donors (14,468) will be deferred under new § 610.41, and thus result in the notification of their referring physicians.

Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this 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 number.

The agency has determined under 21 CFR 25.30(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.

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.

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.

1. Wallace, E. L., W. H. Churchill, D. M. Surgenor, J. An, G. Cho, S. McGurk, and L. Murphy, “Collection and Transfusion of Blood and Blood Components in the United States, 1992,” Transfusion , 1995; vol. 35, No. 10, pp. 802 to 812.

2. Glynn, S. A., G. B. Schreiber, M. P. Busch, S. H. Kleinman, A. E. Williams, C. C. Nass, H. E. Ownby, and J. W. Smith, for the Retrovirus Epidemiology Donor Study entitled “Demographic Characteristics, Unreported Risk Behaviors, and the Prevalence and Incidence of Viral Infections: A Comparison of Aphersis and Whole-Blood Donors,” Transfusion , April 1998, vol. 38, pp. 350 to 358.

Blood, Labeling, Laboratories, Reporting and recordkeeping requirements.

Biologics, Blood, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, parts 606 and 630 are amended as follows:

In 32 CFR part 989, FR Doc. 01-7671 published on March 28, 2001 (66 FR 16868) make the following correction. On page 16869, correcting amendment 45, Appendix C, paragraph A3.1.3, last sentence, correct “USAF/ILEVP” to read “HQ USAF/ILEVP.”

Because EPA received relevant adverse comment, we are withdrawing two of the provisions included in the direct final rule for compliance and monitoring requirements for duct burners used in combined cycle systems. We published the direct final rule (66 FR 18546) and a notice of proposed rulemaking (66 FR 18579) intended to amend the emissions monitoring and compliance provisions for duct burners contained in subparts Da and Db on April 10, 2001.

We stated in that Federal Register that if we received relevant adverse comment by May 10, 2001 on one or more distinct provisions of the direct final rule, we would publish a timely withdrawal of those distinct provisions in the Federal Register . We subsequently received relevant adverse comment on two of the provisions: the revised definition of “boiler operating day” in 40 CFR 60.41a and the data substitution requirement contained in 40 CFR 60.46a(j)(2).

The adverse comments stated that the revised definition of “boiler operating day” and the inclusion of the 40 CFR part 75 data substitution requirement are independent of the amendments addressing the compliance procedures for duct burners. The commenters stated that these provisions are inconsistent with existing subpart Da procedures and their potential impacts were not analyzed or discussed in the proposal. On reviewing the relevant adverse comments, we agreed with their conclusion that these provisions are inconsistent with existing provisions in subpart Da and independent of the provisions addressing the compliance procedures for duct burners. Section 60.47a(c)(2) states that, although 40 CFR part 75 monitors can be used for subpart Da compliance, 40 CFR part 75 missing data and bias adjustment procedures shall not be used. As for the revised definition of “boiler operating day,” § 60.47a(f) requires data to be collected for at least 18 hours in a “boiler operating day.” The proposed revised definition of a “boiler operating day” is inconsistent with this requirement. Therefore, we are withdrawing the revised definition of “boiler operating day” and § 60.46a(j)(2) which contained the requirement for substituting data under 40 CFR part 75.

Based on the adverse comment received, we are amending subpart Da to add a revised § 60.46a(j)(2) which will become effective on June 11, 2001 as provided in the April 10, 2001 direct final rule (66 FR 18546), as appears at the end of this document. This revised § 60.46a(j)(2) differs from the § 60.46a(j)(2) that is being withdrawn from the direct final rule by the deletion of the following statement:

Based on our review of the comments received, we will, therefore, not address the comments on the withdrawn provisions in a subsequent final action on the parallel proposal published at 66 FR 18579.

The provisions for which we did not receive relevant adverse comment, as well as the revised § 60.46a(j)(2), will become effective on June 11, 2001 as provided in the April 10, 2001 direct final rule (66 FR 18546).

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the National Flood Insurance Program, 42 U.S.C. 4001 et seq., unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59 et seq. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in the identified special flood hazard area of communities not participating in the NFIP and identified for more than a year, on the Federal Emergency Management Agency's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Associate Director finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives a 6-month, 90-day, and 30-day notification addressed to the Chief Executive Officer that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications have been made, this final rule may take effect within less than 30 days.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

The Associate Director has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless they take remedial action.

This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp., p. 252.

This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp., p. 309.

The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR Part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

The changes in BFEs are in accordance with 44 CFR 65.4. National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Acting Executive Associate Director for Mitigation certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified BFEs are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This interim rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778.

FEMA makes the final determinations listed below of the final determinations of modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Acting Executive Associate Director for Mitigation, has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modifications are made pursuant to Section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR Part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in BFEs are in accordance with 44 CFR 65.4.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Acting Executive Associate Director for Mitigation certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

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 2 (April through June) 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 2001 calendar year was 3,024,742 lb (1,372,000 kg) (66 FR 12902, March 1, 2001). The quarter 2 period quota, which is equal to 29.26 percent of the annual commercial quota, was 885,040 lb (401,447 kg). The quota allocation was adjusted downward to compensate for 2000 quarter 2 landings in excess of the 2000 quarter 2 quota, consistent with the procedures in § 648.140. The final adjusted quarter 2 quota was 679,519 lb (308,225 kg).

The Regional Administrator, Northeast Region, NMFS (Regional Administrator) monitors 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 2 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 2001 quarter 2 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 2 period for black sea bass no longer has commercial quota available. Therefore, effective 0001 hrs local time, June 10, 2001, 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 June 30, 2001. The 2001 quarter 3 period for commercial black sea bass harvest will open on July 1, 2001. Effective June 10, 2001, 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 2 period (through June 30, 2001).

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.