67270 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Center for Devices and

Radiological Health

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

relating to functions performed by the

Center for Devices and Radiological

Health (CDRH). This amendment

updates the titles of CDRH delegates and

organizational components to reflect the

organizational restructuring and also

publishes delegations of authority to

additional positions within CDRH. This

action is intended to ensure the

accuracy and consistency of the

regulations.

EFFECTIVE DATE: December 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Debra A. Baclawski, Center for

Devices and Radiological Health

(HFZ–026), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301– 443–

1060, or

Donna G. Page, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

4816.

SUPPLEMENTARY INFORMATION: CDRH has

undergone an organizational

restructuring (58 FR 35959, July 2,

1993), which was approved by the

Commissioner of Food and Drugs. The

authorities delegated to the CDRH

officials are amended in this document

to reflect new titles and organization

placement under the restructuring and

also it publishes delegations of authority

to additional positions within the

center.

The most significant changes are: (1)

The establishment of a second Deputy

Director in the Office of the Director,

CDRH, and in the Office of Device

Evaluation; (2) the reorganization and

retitling of the Office of Compliance and

Surveillance to the Office of

Compliance; and (3) the redelegation of

authority to each of the Division

Directors in the Office of Compliance.

Further redelegation of the authorities

delegated is not authorized at this time.

Authority delegated to a position may

be exercised by a person officially

designated to serve in such position in

an acting capacity or on a temporary

basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; 15 U.S.C. 1451–1461; 21 U.S.C.

41–50, 61–63, 141–149, 321–394, 467f,

679(b), 801–886, 1031–1309; 35 U.S.C. 156;

42 U.S.C. 241, 242, 242a, 242l, 242n, 243,

262, 263, 264, 265, 300u–300u–5, 300aa–1;

1395y, 3246b, 4332, 4831(a), 10007–10008;

E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp.,

p. 124–131; E.O. 12591, 52 FR 13414, 3 CFR,

1988 Comp., p. 220–223

2. Section 5.22 is amended by revising

paragraphs (a)(10)(i), (a)(10)(ii),

(a)(10)(iv), and (a)(10)(v) to read as

follows:

§ 5.22 Certification of true copies and use

of Department seal.

(a) * * *

(10)(i) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH).

(ii) The Associate Director and Deputy

Associate Director for Management and

Systems, CDRH.

* * * * *

(iv) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

(v) Freedom of Information Officers,

CDRH.

* * * * *

3. Section 5.23 is amended by revising

paragraphs (c)(1) through (c)(4) to read

as follows:

§ 5.23 Disclosure of official records.

* * * * *

(c) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) The Director and Deputy, Division

of Program Operations, Office of

Compliance, CDRH.

(4) The Chief, Information Processing

and Automation Branch, Division of

Program Operations, Office of

Compliance, CDRH.

* * * * *

4. Section 5.25 is amended by revising

paragraphs (a)(2) and (b) to read as

follows:

§ 5.25 Research, investigation, and testing

programs and health information and health

promotion programs.

(a) * * *

(2) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

* * * * *

(b) The Director and Deputy Directors,

CDRH, are authorized to establish an

electronic product radiation control

program and to approve grants for

conducting the program under section

356 of the act.

* * * * *

5. Section 5.26 is amended by revising

paragraph (c) to read as follows:

§ 5.26 Service fellowships.

* * * * *

(c) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH), and the

Director, Office of Systems and

Management, CDRH.

* * * * *

6. Section 5.28 is revised to read as

follows:

§ 5.28 Cardiac pacemaker devices and

pacemaker leads.

The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), are authorized to

perform all the functions of the

Commissioner of Food and Drugs with

regard to a registry of all cardiac

pacemaker devices and pacemaker leads

for which payment was made under the

Social Security Act (42 U.S.C.

1395y(h)(l),(2)(A), and (3)), as amended.

7. Section 5.30 is amended by revising

paragraphs (b) and (c)(4) to read as

follows:

§ 5.30 Hearings.

* * * * *

(b) The Director and Deputy Directors,

CDRH, are authorized to hold hearings,

and to designate other officials to hold

informal hearings, under section 360(a)

of the Public Health Service Act.

(c) * * *

(4) The Director and Deputy Directors,

CDRH.

* * * * *

8. Section 5.31 is amended by revising

paragraphs (c)(3) and (e)(5) to read as

follows:
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations 67271

§ 5.31 Petitions under part 10.

* * * * *

(c) * * *

(3) The Director and Deputy Directors,

Center for Devices and Radiological

Health.

* * * * *

(e) * * *

(5) The Director and Deputy Directors,

CDRH, are authorized to issue 180-day

tentative responses to citizen petitions

on medical device matters under

§ 10.30(e)(2)(iii) of this chapter that

relate to the assigned functions of that

Center.

* * * * *

9. Section 5.33 is amended by revising

paragraph (b) to read as follows:

§ 5.33 Premarket approval of a product

that is or contains a biologic, a device, or

a drug.

* * * * *

(b) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH), and the

Director, Office of Device Evaluation,

CDRH.

* * * * *

10. Section 5.37 is amended by

revising paragraphs (a)(2)(i) through

(a)(2)(iii) and (b)(1) through (b)(3), and

by removing paragraph (a)(2)(iv) and

removing and reserving (b)(4) to read as

follows:

§ 5.37 Issuance of reports of minor

violations.

(a) * * *

(2)(i) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH).

(ii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iii) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

* * * * *

(b) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

* * * * *

11. Section 5.45 is amended by

revising paragraphs (b) introductory

text, (c)(1) and (c)(2), and (e)(1)(i)

through (e)(1)(iii) to read as follows:

§ 5.45 Imports and exports.

* * * * *

(b) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH); the Director and Deputy

Director, Office of Compliance, CDRH;

Regional Food and Drug Directors;

District Directors; and the Director, St.

Louis Branch, are authorized, under

section 360 of the Public Health Service

Act (PHSA), to perform the following

functions or to designate officials to:

* * * * *

(c) * * *

(1) The Director and Deputy Directors,

CDRH.

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

* * * * *

(e) * * *

(1) * * *

(i) The Director and Deputy Directors,

CDRH.

(ii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iii) The Director and Deputy Director,

Division of Program Operations, Office

of Compliance, CDRH.

* * * * *

12. Section 5.46 is revised to read as

follows:

§ 5.46 Manufacturer’s resident import

agents.

The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH) and the Director and

Deputy Director, Office of Compliance,

CDRH, are authorized to reject

manufacturer’s designation of import

agents under § 1005.25(b) of this

chapter.

13. Section 5.47 is amended by

revising paragraphs (a)(1) and (a)(2) to

read as follows:

§ 5.47 Detention of adulterated or

misbranded medical devices.

* * * * *

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

* * * * *

14. Section 5.49 is amended by

revising paragraph (a) to read as follows:

§ 5.49 Authorization to use alternative

evidence for determination of the

effectiveness of medical devices.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Directors, Office of Device

Evaluation, CDRH.

* * * * *

15. Section 5.50 is amended by

revising paragraph (a) to read as follows:

§ 5.50 Notification to petitioners of

determinations made on petitions for

reclassification of medical devices.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH) and the Director and

Deputy Directors, Office of Device

Evaluation.

* * * * *

16. Section 5.51 is amended by

revising paragraphs (a)(1) and (b)(1) to

read as follows:

§ 5.51 Determination of classification of

devices.

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH) and the Director and

Deputy Directors, Office of Device

Evaluation, CDRH.

* * * * *

(b) * * *

(1) The Director and Deputy Directors,

CDRH, and the Director, Deputy

Directors, Chief of the Premarket

Notification Section, Division and

Deputy Division Directors, Associate

Division Directors, and Branch Chiefs,

Office of Device Evaluation, CDRH.

* * * * *

17. Section 5.52 is amended by

revising paragraph (a) to read as follows:

§ 5.52 Notification to sponsors of

deficiencies in petitions for reclassification

of medical devices.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH) and the Director and

Deputy Directors, Office of Device

Evaluation, CDRH.

* * * * *

18. Section 5.53 is amended by

revising paragraphs (a)(1), (b)(1)(i), and

(c) to read as follows:

§ 5.53 Approval, disapproval, or

withdrawal of approval of product

development protocols and applications for

premarket approval for medical devices.

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Directors, Office of Device

Evaluation, CDRH.

* * * * *

(b)(1) * * *

(i) The Director and Deputy Directors,

CDRH, and the Director and Deputy

Directors, Office of Device Evaluation,

CDRH.

* * * * *

(c) The Director and Deputy Directors,

CDRH, for medical devices assigned to
67272 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations

their organization, are authorized to

issue notices to announce the approval,

disapproval, or withdrawal of approval

of a device, and to make publicly

available a detailed summary of the

information on which the decision was

based, under sections 515(d), (e), and (g)

and 520(h)(1) of the act.

19. Section 5.54 is amended by

revising paragraph (a) to read as follows:

§ 5.54 Determinations that medical devices

present unreasonable risk of substantial

harm.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Compliance,

CDRH.

* * * * *

20. Section 5.55 is amended by

revising paragraph (a) to read as follows:

§ 5.55 Orders to repair or replace, or make

refunds for, medical devices.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Compliance,

CDRH.

* * * * *

21. Section 5.56 is amended by

revising paragraphs (a) and (b) to read

as follows:

§ 5.56 Recall authority.

* * * * *

(a) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH).

(b) The Director and Deputy Director,

Office of Compliance, CDRH.

* * * * *

22. Section 5.57 is amended by

revising paragraphs (a) through (c) to

read as follows:

§ 5.57 Temporary suspension of a medical

device application.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(b) The Director and Deputy Director,

Office of Compliance, CDRH.

(c) The Director and Deputy Directors,

Office of Device Evaluation, CDRH.

* * * * *

23. Section 5.59 is amended by

revising paragraph (a)(1) to read as

follows:

§ 5.59 Approval, disapproval, or

withdrawal of approval of applications for

investigational device exemptions.

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), the Director and Deputy

Directors, Office of Device Evaluation,

CDRH, and the Director and Deputy

Director, Office of Compliance, CDRH.

* * * * *

24. Section 5.60 is amended by

revising paragraphs (a)(1) through (a)(4),

(a)(6), and (b)(1) through (b)(5) to read

as follows:

§ 5.60 Required and discretionary

postmarket surveillance.

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(2) The Director and Deputy Director,

Office of Surveillance and Biometrics,

CDRH.

(3) The Director and Deputy Director,

Division of Postmarket Surveillance,

Office of Surveillance and Biometrics,

CDRH.

(4) The Director and Deputy Directors,

Division Directors and Associate

Division Directors, Office of Device

Evaluation, CDRH.

* * * * *

(6) The Director and Deputy Director,

Office of Compliance, CDRH.

* * * * *

(b) * * *

(1) The Director and Deputy Directors,

CDRH.

(2) The Director and Deputy Director,

Office of Surveillance and Biometrics,

CDRH.

(3) The Director and Deputy Director,

Division of Postmarket Surveillance,

Office of Surveillance and Biometrics,

CDRH.

(4) The Director and Deputy Directors,

Office of Device Evaluation, CDRH.

(5) The Director and Deputy Director,

Office of Compliance, CDRH.

* * * * *

25. Section 5.78 is amended by

revising paragraph (b) to read as follows:

§ 5.78 Issuance, amendment, or repeal of

regulations pertaining to antibiotic drugs.

* * * * *

(b) The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to perform all the

functions of the Commissioner of Food

and Drugs under section 507 of the act

regarding the issuance, amendment, or

repeal of regulations pertaining to

antibiotic drugs for human use

contained in medical devices.

26. Section 5.86 is amended by

revising paragraphs (a) and (b), and by

removing paragraph (c) to read as

follows:

§ 5.86 Variances from performance

standards for electronic products.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(b) The Director and Deputy Director,

Office of Compliance, CDRH.

27. Section 5.87 is amended by

revising paragraphs (a) and (b), and by

removing paragraph (c) to read as

follows:

§ 5.87 Exemption of electronic products

from performance standards and prohibited

acts.

* * * * *

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(b) The Director and Deputy Director,

Office of Compliance, CDRH.

28. Section 5.88 is revised to read as

follows:

§ 5.88 Testing programs and methods of

certification and identification for electronic

products.

The Director and Deputy Directors,

Center for Devices and Radiological

Health, (CDRH), and the Director and

Deputy Director, Office of Compliance,

CDRH, are authorized to review and

evaluate industry testing programs

under section 358(g) of the Public

Health Service Act (the act), and to

approve or disapprove alternate

methods of certification and

identification and to disapprove testing

programs upon which certification is

based under section 358(h) of the act.

29. Section 5.89 is amended by

revising paragraphs (a) introductory text

and (b) introductory text to read as

follows:

§ 5.89 Notification of defects in, and repair

or replacement of, electronic products.

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Compliance,

CDRH, are authorized to perform all

functions of the Commissioner of Food

and Drugs, relating to notification of

defects in, noncompliance of, and repair

or replacement of or refund for,

electronic products under section 359 of

the Public Health Service Act (the act)

and under §§ 1003.11, 1003.22, 1003.31,

1004.2, 1004.3, 1004.4, and 1004.6 of

this chapter; and Regional Food and

Drug Directors, District Directors, and

the Director, St. Louis Branch, are

authorized to perform all such functions

relating to:

* * * * *

(b) The Director and Deputy Director,

Office of Compliance, CDRH, and the
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Rules and Regulations 67273

Division Directors, Office of

Compliance, CDRH, are authorized to

notify manufacturers of defects in, and

noncompliance of, electronic products

under section 359(e) of the act and

under § 1003.11(a) of this chapter; and

the chiefs of District Compliance

Branches are authorized to perform all

such functions relating to:

* * * * *

30. Section 5.90 is revised to read as

follows:

§ 5.90 Manufacturers requirement to

provide data to ultimate purchasers of

electronic products.

The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to require

manufacturers to provide performance

and technical data to the ultimate

purchaser of electronic products under

section 360A(c) of the Public Health

Service Act.

31. Section 5.91 is revised to read as

follows:

§ 5.91 Dealer and distributor direction to

provide data to manufacturers of electronic

products.

The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), the Director and Deputy

Director, Office of Compliance, CDRH,

and the Division Directors, Office of

Compliance, CDRH, are authorized to

direct dealers and distributors of

electronic products to furnish

information on first purchasers of such

products to the manufacturer of the

product under section 360A(f) of the

Public Health Service Act.

32. Section 5.92 is revised to read as

follows:

§ 5.92 Acceptance of assistance from

State and local authorities for enforcement

of radiation control legislation and

regulations.

The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to accept

assistance from State and local

authorities engaged in activities related

to health or safety or consumer

protection on a reimbursable basis or

otherwise, under section 360E of the

Public Health Service Act.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33482 Filed 12–23–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Decoquinate and Bacitracin

Zinc With Roxarsone

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of an abbreviated new animal

drug application (ANADA) filed by

ALPHARMA INC. The ANADA

provides for using approved

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated broiler chicken

feeds used for prevention of coccidiosis,

increased rate of weight gain, and

improved feed efficiency.

EFFECTIVE DATE: December 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION:

ALPHARMA INC., One Executive Dr.,

P.O. Box 1399, Fort Lee, NJ 07024, is

sponsor of ANADA 200–206 that

provides for combining approved

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds for

broilers containing decoquinate 27.2

grams per ton (g/t) and bacitracin zinc

12 to 50 g/t with roxarsone 11 to 45 g/

t. The Type C medicated feed is used for

the prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. mivati, E. maxima, and E.

brunetti, and for increased rate of weight

gain and improved feed efficiency.

ALPHARMA INC.’s, ANADA 200–206

is approved as a generic copy of Rhone

Poulenc Inc.’s NADA 91–326. The

ANADA is approved as of December 24,

1997 and the regulations are amended

in 21 CFR 558.195(d) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

This approval is for use of three single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

roxarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). As

provided in 21 CFR 558.4(b), an

approved form FDA 1900 is required to

make a Type C medicated feed from a

Category II drug. Under section 512(m)

of the act (21 U.S.C. 360b(m)), as

amended by the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

decoquinate, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds as

provided in NADA 200–206 is limited

to manufacture in a licensed feed mill.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33 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.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.195 [Amended]

2. Section 558.195 Decoquinate is

amended in the table in paragraph (d) in

the entry for ‘‘27.2 (0.003 pct),

Roxarsone 11 to 45 (0.0012–0.005 pct.)

plus Bacitracin 12 to 50’’ under

‘‘Limitations’’ by removing ‘‘No.

011716’’ and adding in its place ‘‘Nos.

011716 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinar Medicine.

[FR Doc. 97–33638 Filed 12–23–97; 8:45 am]

BILLING CODE 4160–01–F