40024 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 /Rules and Regulations

application is deemed by the Bank to be

complete, and shall maintain a copy of

such letter in the applicant’s

membership file. The Bank shall notify

an applicant if the 60-day clock is

stopped, and when the clock is

resumed, and shall maintain a written

record of such notifications in the

applicant’s membership file. * * *

* * * * *

8. Section 933.4 is amended by

adding paragraph (d) to read as follows:

§ 933.4 Automatic membership.

* * * * *

(d) Automatic membership, in the

Bank’s discretion, for certain

consolidations. (1) If a member

institution (or institutions) and a

nonmember institution are consolidated

and the consolidated institution has its

principal place of business in a state in

the same Bank district as the

disappearing institution (or

institutions), and the consolidated

institution will operate under the

charter of the nonmember institution,

on the effective date of the

consolidation, the consolidated

institution may, in the discretion of the

Bank of which the disappearing

institution (or institutions) was a

member immediately prior to the

effective date of the consolidation,

automatically become a member of such

Bank upon the purchase of stock in that

Bank pursuant to § 933.20, provided

that:

(i) 90 percent or more of the total

assets of the consolidated institution are

derived from the total assets of the

disappearing member institution (or

institutions); and

(ii) The consolidated institution

provides written notice to such Bank,

within 60 calendar days after the

effective date of the consolidation, that

it desires to be a member of the Bank.

(2) The provisions of § 933.25(d)(1)(i)

shall apply, and upon approval of

automatic membership by the Bank, the

provisions of §§ 933.25(d)(2)(i), (e) and

(f) shall apply.

9. Section 933.11 is amended by

revising paragraphs (b)(3)(i)(B) and

(b)(3)(i)(C) to read as follows:

§ 933.11 Financial condition requirement

for applicants other than insurance

companies.

* * * * *

(b) * * *

(3) * * *

(i) * * *

(B) Nonperforming assets. The

applicant’s nonperforming loans and

leases plus other real estate owned, did

not exceed 10 percent of its total loans

and leases plus other real estate owned,

in the most recent calendar quarter; and

(C) Allowance for loan and lease

losses. The applicant’s ratio of its

allowance for loan and lease losses plus

the allocated transfer risk reserve to

nonperforming loans and leases was 60

percent or greater during 4 of the 6 most

recent calendar quarters.

* * * * *

10. Section 933.14 is amended by

removing the heading for paragraph (a),

revising paragraph (a)(1), and removing

and reserving paragraph (b), as follows:

§ 933.14 De novo insured depository

institution applicants.

(a)(1) Duly organized, subject to

inspection and regulation, financial

condition and character of management

requirements. An insured depository

institution applicant whose date of

charter approval is within three years

prior to the date the Bank receives the

applicant’s application for membership

in the Bank, is deemed to meet the

requirements of §§ 933.7, 933.8, 933.11

and 933.12.

* * * * *

11. Section 933.15 is amended by

adding new paragraph (c) to read as

follows:

§ 933.15 Recent merger or acquisition

applicants.

* * * * *

(c) Makes long-term home mortgage

loans requirement; 10 percent

requirement. For purposes of

determining compliance with §§ 933.9

and 933.10, a Bank may, in its

discretion, permit an applicant that, as

a result of a merger or acquisition

preceding the date the Bank receives its

application for membership, has not yet

filed a consolidated regulatory financial

report as a combined entity with its

appropriate regulator, to provide the

combined pro forma financial statement

for the combined entity filed with the

regulator that approved the merger or

acquisition.

* * * * *

§ 933.20 [Amended]

12. Section 933.20 is amended by

removing the citation ‘‘§ 933.4(a)’’ in

paragraphs (b)(1) and (b)(2) and adding

the citation ‘‘§ 933.4(a) or (d)’’ in its

place.

Dated: June 24, 1998.

By the Board of Directors of the Federal

Housing Finance Board.

Bruce A. Morrison,

Chairman.

[FR Doc. 98–19912 Filed 7–24–98; 8:45 am]

BILLING CODE 6725–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0274]

Food Labeling; Petitions for Nutrient

Content and Health Claims, General

Provisions; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

document that appeared in the Federal

Register of May 14, 1998 (63 FR 26717).

The document amended FDA’s

regulations to define the conditions

under which certain petitions for

nutrient content and health claims shall

be deemed to be denied and to codify

the statutory timeframe within which

the agency will complete rulemakings

on such petitions. The document was

published with some errors. This

document corrects those errors.

DATES: Effective July 27, 1998.

FOR FURTHER INFORMATION CONTACT:

Hilario R. Duncan, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202–

205–8281.

In FR Doc. 98–12832, appearing on

page 26717 in the Federal Register of

Thursday, May 14, 1998, the following

corrections are made:

1. On page 26718, in the first column,

in the first paragraph under

Supplementary Information, beginning

in the thirtieth line, the phrase ‘‘to

include the statutory language, i.e.,

‘Secretary’ is replaced with ‘FDA’’’ is

corrected to read ‘‘by inserting the

statutory language (with ‘Secretary’

replaced by ‘FDA’)’’.

§ 101.69 [Corrected]

3. On page 26719, in the first column,

in paragraph (m)(3), in the fifteenth line,

the phrase ‘‘denied without filing,’’ is

corrected to read ‘‘denied, without

filing’’.

4. On page 26719, in the first column,

in paragraph (m)(4)(iii), in the second

line, the phrase ‘‘of the filing date’’ is

corrected to read ‘‘of the date of filing’’.

§ 101.70 [Corrected]

5. On page 26719, in the second

column, in paragraph (j)(3)(iii), in the

second line, the phrase ‘‘of the filing

date’’ is corrected to read ‘‘of the date

of filing’’.
Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 /Rules and Regulations 40025

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19895 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 95N–0176]

RIN 0910–ZA12

Orthopedic Devices: Classification and

Reclassification of Pedicle Screw

Spinal Systems

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying

certain previously unclassified

preamendments pedicle screw spinal

systems into class II (special controls)

and reclassifying certain

postamendments pedicle screw spinal

systems from class III (premarket

approval) to class II. FDA is taking this

action because it believes that special

controls would provide reasonable

assurance of safety and effectiveness.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (FDAMA).

EFFECTIVE DATE: August 26, 1998.

FOR FURTHER INFORMATION CONTACT: Aric

D. Kaiser, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Regulatory History of the Device

III. Summary of the Final Rule

IV. Proposed Rule Clarifications

V. Analysis of Comments and FDA’s

Response

A. Issues Relating to the Recommendations

of the Panel, FDA’s Tentative Findings, and

Summary of the Data Upon Which FDA’s

Findings Were Based

B. Issues Relating to Information Published

in the 1994 Supplementary Issue of the

Journal Spine (vol. 20S, 1994)

C. Issues Relating to the January 1995,

510(k) Substantial Equivalence

Determination for a Pedicle Screw Spinal

System Intended for Severe

Spondylolisthesis

D. Issues Relating to Misstatements or

False Statements Appearing in the Proposed

Rule

E. Issues Relating to the FDA’s Issuance of

Regulations

F. Responses to Comments Which

Contained Clinical Data

G. Requests for Additional Pedicle Screw

Clinical Trials and Data Analyses

H. Issues Relating to Indications for Use

I. Issues Relating to Special Controls

J. Other Issues

K. Labeling of Bone Screws

L. Review of New Pedicle Screw Spinal

System 510(k)’s

M. Review of New Information Published

and Submitted After Publication of the

Proposed Rule: Pedicle Screw and Related

Literature and MedWatch and MDR System

Reports

VI. References

VII. Environmental Impact

VIII. Analysis of Impacts

I. Background

The act (21 U.S.C. 331 et seq.), as

amended by the 1976 amendments (Pub.

L. 94–295), the SMDA (Pub. L. 101–

629), and FDAMA (Pub. L. 105–115),

established a comprehensive system for

the regulation of medical devices

intended for human use. Section 513 of

the act (21 U.S.C. 360c) established

three categories (classes) of devices,

depending on the regulatory controls

needed to provide reasonable assurance

of their safety and effectiveness. The

three categories of devices are: Class I

(general controls), class II (special

controls), and class III (premarket

approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with new

section 513(f)(2) of the act, as amended

by FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and part 807 of the

regulations (21 CFR part 807).

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA

promulgates a final regulation under

section 515(b) of the act (21 U.S.C.

360e(b)) requiring premarket approval.

Reclassification of classified

preamendments devices is governed by

section 513(e) of the act. This section

provides that FDA may, by rulemaking,

reclassify a device (in a proceeding that

parallels the initial classification

proceeding) based upon ‘‘new

information.’’ The reclassification can

be initiated by FDA or by the petition

of an interested person. The term ‘‘new

information,’’ as used in section 513(e)

of the act, includes information

developed as a result of a reevaluation

of the data before the agency when the

device was originally classified, as well

as information not presented, not

available, or not developed at that time.

(See, e.g., Holland Rantos v. United

States Department of Health, Education,

and Welfare, 587 F.2d 1173, 1174 n.1

(D.C. Cir. 1978); Upjohn v. Finch, 422

F.2d 944 (6th Cir. 1970); Bell v.

Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously

before the agency is an appropriate basis

for subsequent regulatory action where

the reevaluation is made in light of

newly available regulatory authority

(see Bell v. Goddard, supra, 366 F.2d at

181; Ethicon, Inc. v. FDA, 762 F. Supp.

382, 389–91 (D.D.C. 1991)), in light of

changes in ‘‘medical science.’’ (See

Upjohn v. Finch, supra, 422 F.2d at

951.) Regardless of whether data before

the agency are past or new data, the

‘‘new information’’ on which any

reclassification is based is required to

consist ‘‘valid scientific evidence,’’ as

defined in section 513(a)(3) of the act

and § 860.7(c)(2) (21 CFR 860.7(c)(2)).

(See, e.g., General Medical Co. v. FDA,

770 F.2d 214 (D.C. Cir. 1985); Contact

Lens Assoc. v. FDA, 766 F.2d 592 (D.C.

Cir.), cert. denied, 474 U.S. 1062

(1985).) FDA relies upon ‘‘valid

scientific evidence’’ in the classification

process to determine the level of