Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31165

infection due to communicable disease

agents listed in § 610.40(a); and

(2) Human immunodeficiency virus

(HIV) test kit approved for use in the

diagnosis, prognosis, or monitoring of

this communicable disease agent.

(b) You must not distribute a lot that

is found to be not acceptable for

sensitivity and specificity under

§ 610.44(a). FDA may approve an

exception or alternative to this

requirement. Applicants must submit

such requests in writing. However, in

limited circumstances, such requests

may be made orally and permission may

be given orally by FDA. Oral requests

and approvals must be promptly

followed by written requests and

written approvals.

§ 610.45 [Removed]

12. Section 610.45 Human

Immunodeficiency Virus (HIV)

requirements is removed.

PART 640—ADDITIONAL STANDARDS

FOR HUMAN BLOOD AND BLOOD

PRODUCTS

13. The authority citation for 21 CFR

part 640 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,

264.

§ 640.2 [Amended]

14. Section 640.2 General

requirements is amended by removing

paragraph (d).

15. Section 640.5 is amended by

revising paragraph (f).

§ 640.5 Testing the blood.

* * * * *

(f) Test for communicable disease

agents. Whole Blood shall be tested for

evidence of infection due to

communicable disease agents as

required under § 610.40 of this chapter.

§ 640.14 [Amended]

16. Section 640.14 Testing the blood

is amended by removing ‘‘§§ 610.40 and

610.45’’ and by adding in its place ‘‘

§ 610.40’’.

§ 640.23 [Amended]

17. Section 640.23 Testing the blood

is amended in paragraph (a) by

removing ‘‘§§ 610.40 and 610.45’’ and

by adding in its place ‘‘§ 610.40’’.

§ 640.33 [Amended]

18. Section 640.33 Testing the blood

is amended in paragraph (a) by

removing ‘‘§§ 610.40 and 610.45’’ and

by adding in its place ‘‘§ 610.40’’.

§ 640.53 [Amended]

19. Section 640.53 Testing the blood

is amended in paragraph (a) by

removing ‘‘§§ 610.40 and 610.45’’ and

by adding in its place ‘‘§ 610.40’’.

20. Section 640.67 is revised to read

as follows:

§ 640.67 Laboratory tests.

Each unit of Source Plasma shall be

tested for evidence of infection due to

communicable disease agents as

required under § 610.40 of this chapter.

21. Section 640.70 is amended by

revising paragraph (a)(2).

§ 640.70 Labeling.

(a) * * *

(2) The statement ‘‘Caution: For

Manufacturing Use Only’’ for products

intended for further manufacturing into

injectable products, or the statement,

‘‘Caution: For Use In Manufacturing

Noninjectable Products Only’’, for

products intended for further

manufacturing into noninjectable

products. The statement shall follow the

proper name in the same size and type

of print as the proper name. If the

Source Plasma has a reactive screening

test for evidence of infection due to a

communicable disease agent(s) under

§ 610.40 of this chapter, or is collected

from a donor with a previous record of

a reactive screening test for evidence of

infection due to a communicable

disease agent(s) under § 610.40 of this

chapter, the Source Plasma must be

labeled under § 610.40(h)(2)(ii)(E) of this

chapter.

* * * * *

PART 660—ADDITIONAL STANDARDS

FOR DIAGNOSTIC SUBSTANCES FOR

LABORATORY TESTS

22. The authority citation for 21 CFR

part 660 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 360, 360c, 360d, 360h, 360i, 371,

372; 42 U.S.C. 216, 262, 263, 263a, 264.

§ 660.42 [Removed]

23. Section 660.42 Reference panel is

removed.

PART 809—IN VITRO DIAGNOSTIC

PRODUCTS FOR HUMAN USE

24. The authority citation for 21 CFR

part 809 continues to read as follows:

Authority: 21 U.S.C. 331, 351, 352, 355,

360b, 360c, 360d, 360h, 360i, 360j, 371, 372,

374, 381.

25. Section 809.20 is amended by

revising paragraph (b).

§ 809.20 General requirements for

manufacturers and producers of in vitro

diagnostic products.

* * * * *

(b) Compliance with good

manufacturing practices. In vitro

diagnostic products shall be

manufactured in accordance with the

good manufacturing practices

requirements found in part 820 of this

chapter and, if applicable, with § 610.44

of this chapter.

Dated: June 1, 2001.

Bernard A. Schwetz,

Acting Principal Deputy Commissioner.

[FR Doc. 01–14408 Filed 6–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 606 and 630

[Docket No. 98N–0607]

General Requirements for Blood,

Blood Components, and Blood

Derivatives; Donor Notification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

biologics regulations to require blood

and plasma establishments to notify

donors, including autologous donors,

whenever the donor is deferred or

determined not to be suitable for current

or future donations of blood and blood

components. A donor is 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. Blood and

plasma establishments also are required

to notify the referring physician of an

autologous donor when the autologous

donor is deferred based on tests for

evidence of infection with a

communicable disease agent(s). A

standard operating procedure (SOP) and

recordkeeping also are required. This

final rule is intended to help protect

public health and to promote

consistency in the industry. Elsewhere

in this issue of the Federal Register,

FDA is publishing a final rule on the

requirements for testing human blood

donors for evidence of infection due to

communicable disease agents.

DATES: This rule is effective December

10, 2001.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

31166 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

I. Background

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.

II. Highlights and Summary of the Final

Rule

A. Plain Language

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.’’

B. Final Rule

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.

III. Comments on the Proposed Rule

and FDA Responses

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.

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31167

A . Scope of the Notification Rule

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.

31168 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

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.’’

B. Notification of Deferred Autologous

Donors

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

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31169

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.

C. Notification Based on Results of Tests

for HTLV, Types I and II, and Anti-HBc

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 antihepatitis B core (anti-HBc). The agency

requested comments on whether to

notify donors who test reactive for antiHTLV, 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).

D. Notification of Donors Determined

Not to Be Suitable for Donation Based

on Failure to Satisfy Suitability Criteria

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

31170 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

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 longas 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-bycase 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.

E. Method of Notification—How to

Notify the Donor

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

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31171

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.

F. Permanent Address

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.

IV. Analysis of Impacts

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.

A. Objectives and Basis of the Action

As discussed previously, FDA is

implementing this action to helpprotect

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.

B. Nature of the Impact

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

31172 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

1This percentage is based on American National

Red Cross estimates based on donations between

January 1996 and June 1997.

2The estimate of an average of two donations per

year for repeat blood donors is based on the Centers

for Disease Control’s analysis of blood donations

prepared for HCV lookback.

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.

C. Type and Number of Entities Affected

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.

D. Estimated Impact of Requirements for

Donor Notification

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 onethird, 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 donors1

(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 year2 (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

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31173

3A description of SIC major group 80 can be

found at: http://www.osha.gov/cgi-bin/sic/

sicser4?80.

4The SBA criteria for small business, listed by

SIC code can be found at: http://www.sba.gov/

regulations/siccodes/siccodes.pdf.

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.

E. Expected Benefits of the Rule

As described in the preamble to this

rule, notification of donors thatthey

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 selfdefer 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.

F. Small Entity Impact

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 onetime 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

donornotification 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.

31174 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

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.

V. The Paperwork Reduction Act of

1995

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.

A. Standard Operating Procedures

(§ 606.100(b)(20))

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.

B. Records (§ 606.160(b)(1)(ix) to

(b)(1)(xi))

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.

C. Donor Notification (New Part 630)

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 screeningtest 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.

D. Annual Reporting Burden (Table 1)

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

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31175

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.

E. Recordkeeping Burden (Table 2)

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 ongoing 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.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. ofRespondents AnnualFrequency

perResponse

Total Annual Responses Hours perResponse Total Hours

630.6(a)2 344 1,163 400,000 0.08 32,000

630.6(a)3 52 164 8,550 1.5 12,825

630.6(d)(1) 52 124 6,430 1 6,430

Total 51,255

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2 Notification of donors determined not to be suitable for donation based on failure to satisfy suitability criteria.

3 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

606.100(b)(20) (maintenance of SOP’s) 1,041 1 1,041 1 1,041

606.160(b)(1)(ix) 1,041 1,563 1,627,500 0.05 81,375

606.160(b)(1)(xi) 981 15 14,468 0.05 723

Total 83,139

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3.—ESTIMATED ONE-TIME RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records Hours per Record Total Hours

606.100(b)(20) 1,041 1 1,041 7 7,287

1There are no capital costs or operating and maintenance costs associated with this collection of information.

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.

31176 Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations

VI. Environmental Impact

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.

VII. Federalism

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.

VIII. References

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 WholeBlood Donors,’’ Transfusion, April

1998, vol. 38, pp. 350 to 358.

Lists of Subjects

21 CFR Part 606

Blood, Labeling, Laboratories,

Reporting and recordkeeping

requirements.

21 CFR Part 630

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:

PART 606—CURRENT GOOD

MANUFACTURING PRACTICE FOR

BLOOD AND BLOOD COMPONENTS

1. The authority citation for 21 CFR

part 606 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

355, 360, 360j, 371, 374; 42 U.S.C. 216, 262,

263a, 264.

2. Section 606.100 is amended by

adding paragraph (b)(20) to read as

follows:

§ 606.100 Standard operating procedures.

* * * * *

(b) * * *

(20) Procedures for donor deferral as

prescribed in § 610.41 of this chapter;

and procedures for donor notification

and autologous donor referring

physician notification, including

procedures for the appropriate followup

if the initial attempt at notification fails,

as prescribed in § 630.6 of this chapter.

* * * * *

3. Section 606.160 is amended by

adding paragraphs (b)(1)(ix) to (b)(1)(xi)

to read as follows:

§ 606.160 Records.

* * * * *

(b) * * *

(1) * * *

(ix) Records of notification of donors

deferred or determined not to be

suitable for donation, including

appropriate followup if the initial

attempt at notification fails, performed

under § 630.6 of this chapter.

(x) The donor’s address provided at

the time of donation where the donor

may be contacted within 8 weeks after

donation.

(xi) Records of notification of the

referring physician of a deferred

autologous donor, including appropriate

followup if the initial notification

attempt fails, performed under § 630.6

of this chapter.

* * * * *

4. Part 630 is added to read as follows:

PART 630—GENERAL

REQUIREMENTS FOR BLOOD, BLOOD

COMPONENTS, AND BLOOD

DERIVATIVES

Sec.

630.6 Donor notification.

Authority: 21 U.S.C. 321, 331, 351, 352,

355, 360, 371; 42 U.S.C. 216, 262, 264.

§ 630.6 Donor notification.

(a) Notification of donors. You, an

establishment that collects blood or

blood components, must make

reasonable attempts to notify any donor,

including an autologous donor, who has

been deferred based on the results of

tests for evidence of infection with a

communicable disease agent(s) as

required by § 610.41 of this chapter; or

who has been determined not to be

suitable as a donor based on suitability

criteria under § 640.3 or § 640.63 of this

chapter. You must attempt to obtain the

results of supplemental testing required

under § 610.40(e) of this chapter prior to

notifying a donor of the deferral. If

notification occurs prior to receipt of

such results, you must also notify a

deferred donor of the results of the

supplemental testing. You must notify a

donor as described in paragraph (b) of

this section.

(b) Content of notification. You must

provide the following information to a

donor deferred or determined not to be

suitable as a donor as described in

paragraph (a) of this section:

(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

donation of blood or 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 under § 610.41

of this chapter, including results of

supplemental (i.e., additional, more

specific) tests as required in § 610.40(e)

of this chapter; and,

(4) Where appropriate, information

concerning medical followup and

counseling.

(c) Time period for notification. You

must make reasonable attempts to notify

the donor within 8 weeks after

determining that the donor is deferred

or determined not to be suitable for

donation as described in paragraph (a)

of this section. You must document that

you have successfully notified the donor

or when you are unsuccessful that you

have made reasonable attempts to notify

the donor.

(d) Autologous donors. (1) You also

must provide the following information

to the referring physician of an

autologous donor who is deferred based

on the results of tests for evidence of

infection with a communicable disease

agent(s) as described in paragraph (a) of

this section:

(i) Information that the autologous

donor is deferred based on the results of

tests for evidence of infection due to

communicable disease agent(s), as

required under § 610.41 of this chapter,

and the reason for that decision;

(ii) Where appropriate, the types of

donation of blood or blood components

Federal Register / Vol. 66, No. 112 / Monday, June 11, 2001 / Rules and Regulations 31177

that the autologous donor should not

donate in the future; and

(iii) The results of tests for evidence

of infection due to communicable

disease agent(s), that were a basis for

deferral under § 610.41 of this chapter,

including results of supplemental (i.e.,

additional, more specific) tests as

required in § 610.40(e) of this chapter.

(2) You must make reasonable

attempts to notify the autologous

donor’s referring physician within 8

weeks after determining that the

autologous donor is deferred as

described in paragraph (a) of this

section. You must document that you

have successfully notified the

autologous donor’s referring physician

or when you are unsuccessful that you

have made reasonable attempts to notify

the physician.

Dated: June 1, 2001.

Bernard A. Schwetz,

Acting Principal Deputy Commissioner.

[FR Doc. 01–14409 Filed 6–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Air Force

32 CFR Part 989

RIN 0701–AA56

Environmental Impact Analysis

Process (EIAP); Correction

AGENCY: Department of the Air Force,

DoD.

ACTION: Final rule; correction.

SUMMARY: The Department of the Air

Force published in the Federal Register

of March 28, 2001, a document

concerning correcting amendments.

This document corrects the inadvertent

change to correcting amendment 45.

DATES: Effective on July 11, 2001.

FOR FURTHER INFORMATION CONTACT: Mr.

Jack Bush (HQ USAF/ILEB), 1260 Air

Force Pentagon, Washington, DC 20330–

1260, (703) 604–0553.

SUPPLEMENTARY INFORMATION: 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.’’

Dated: May 31, 2001.

Janet A. Long,

Air Force Federal Register Liaison Officer.

[FR Doc. 01–14681 Filed 6–8–01; 8:45 am]

BILLING CODE 5001–05–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 60

[FRL–6995–2]

RIN 2060–AE56

Standards of Performance for Electric

Utility Steam Generating Units for

Which Construction is Commenced

After September 18, 1978; Standards of

Performance for IndustrialCommercial-Institutional Steam

Generating Units

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Partial withdrawal of direct

final rule.

SUMMARY: Due to relevant adverse

comment, the EPA is withdrawing two

provisions from the direct final rule

published on April 10, 2001 for Subpart

Da—Standards of Performance for

Electric Utility Steam Generating Units

for Which Construction is Commenced

After September 18, 1978, and Subpart

Db—Standards of Performance for

Industrial-Commercial-Institutional

Steam Generating Units (66 FR 18546).

These provisions deal with the revised

definition of ‘‘boiler operating day’’ and

the data substitution requirement for

missing data.

DATES: This rule is effective June 11,

2001. As of June 11, 2001, the EPA

withdraws the revised definition of

‘‘boiler operating day’’ in 40 CFR

§ 60.41a and 60.46a(j)(2) published on

April 10, 2001 (66 FR 18546). The

remaining provisions published on

April 10, 2001 will be effective June 11,

2001 as stated in the April 10, 2001

direct final rule. The addition of 40 CFR

60.46a(j)(2), which deletes the data

substitution requirement for missing

data, is effective June 11, 2001.

ADDRESSES: Docket number A–92–71,

containing supporting information used

in the development of this notice is

available for public inspection and

copying between 8:00 a.m. and 5:30

p.m., Monday through Friday (except

for Federal holidays) at the following

address: U.S. Environmental Protection

Agency, Air and Radiation Docket and

Information Center (6102), 401 M Street,

SW, Washington, DC 20460, or by

calling (202) 260–7548. A reasonable fee

may be charged for copying docket

materials.

FOR FURTHER INFORMATION CONTACT: Mr.

James Eddinger, Combustion Group,

Emission Standards Division (MD–13),

Office of Air Quality Planning and

Standards, U.S. EPA, Research Triangle

Park, NC 27711, telephone number (919)

541–5426, electronic mail address:

eddinger.jim@epa.gov.

SUPPLEMENTARY INFORMATION: 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