Federal Register / Vol. 63, No. 81 /Tuesday, April 28, 1998 / Notices 23291

26. How should individuals/parents have

access to registry information on themselves/

their children?

27. Should data maintained in a state and

community-based immunization registry be

considered public information?

28. Would national privacy and

confidentiality standards help ensure that

data maintained in an immunization registry

is protected?

Ensuring Provider Participation Questions

To Be Considered

1. What type of resources (e.g., hardware,

staff, etc.) are needed for you (provider/

organization) to participate in a

computerized registry?

2. What are the cost-related barriers that

keep you (provider/organization) from

participating in an immunization registry?

3. What cost should providers be

responsible for, pertaining to participation in

immunization registry systems?

4. What are the cost savings you would

anticipate as a result of participating in a

computerized registry (e.g., increased return

visit form reminders, less personnel

paperwork for preschool exams, etc.)?

5. How much time would you be willing

to invest per patient visit (e.g., additional 1,

5, 7, 10 minutes) in the overall success of an

immunization registry?

6. What type of user support would be

needed in order for you (provider/

organization) to participate in an

immunization registry?

7. How would you (provider/organization)

encourage providers and consumers in your

community to participate in an

immunization registry?

8. What community support would be

necessary for you to participate in the

immunization registry?

9. What benefits/value (e.g., immunization

reminders, quick access to immunization

histories, etc.) would a registry provide that

would encourage your (provider/

organization) participation?

10. What incentives should be offered to

providers/organizations to participate in an

immunization registry?

11. What barriers have you (provider/

organization) encountered that have

prevented you from participating in an

immunization registry?

12. Is provider liability (e.g, disclosure of

sensitive patient information) a barrier to

participating in an immunization registry?

Why?

13. How would an immunization registry

impact your practice/organization?

14. Do you currently share immunization

data with other providers electronically? For

what purpose (e.g., billing, share group data,

etc.)?

15. How (e.g., electronic record, paper

record) is medical information maintained in

your practice/organization?

16. Who should retain ownership of

immunization records as they are distributed

throughout an immunization registry?

17. How would you (provider/

organization) use the data maintained in an

immunization registry?

18. What type of quality control process

would you (provider/organization) perform

to ensure the accuracy and completeness of

the immunization data entered into an

immunization registry?

19. What type of security policies and

procedures need to be in place for you to be

confident that data are secure?

20. What functions should a registry

perform in your office in order for you

(provider/organization) to participate?

21. Do you have any advice or

recommendations for NVAC/CDC/HHS

related to the implementation of the network

of state and community-based registries and

do you have any concerns?

22. Do you feel that there is a need for the

Federal Government to provide leadership in

developing state and community-based

immunization registries? What should the

role of the Federal Government be in this

effort?

23. Have you received training on the use

and maintenance of computerized medical

information? Do you feel this training is

needed to fully support the development and

maintenance of immunization registries?

Contact Person for More Information: Robb

Linkins, M.P.H., Ph.D., Chief, Systems

Development Branch, Data Management

Division, NIP, CDC, 1600 Clifton Road, NE,

M/S E–62, Atlanta, GA 30333, telephone

(404) 639–8728, e-mail rxl3@cdc.gov.

Dated: April 22, 1998.

Joseph E. Salter,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–11185 Filed 4–27–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95D–0349]

Draft Guidance for Industry on

SUPAC–IR/MR: Immediate Release and

Modified Release Solid Oral Dosage

Forms, Manufacturing Equipment

Addendum; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘SUPAC–IR/MR:

Immediate Release and Modified

Release Solid Oral Dosage Forms,

Manufacturing Equipment Addendum.’’

This draft guidance is intended to

provide insight and recommendations to

pharmaceutical sponsors of new drug

applications (NDA’s) and abbreviated

new drug applications (ANDA’s) who

wish to change equipment during the

postapproval period.

DATES: Written comments may be

submitted on the draft guidance

document by June 29, 1998. General

comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm.’’ Written requests for single

copies of the draft guidance for industry

should be submitted to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Submit

written comments on the draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

L. Smith, Center for Drug Evaluation

and Research (HFD–590), Food and

Drug Administration, 9201 Corporate

Blvd., Rockville, MD 20850, 301–827–

2175.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘SUPAC–

IR/MR: Immediate Release and Modified

Release Solid Oral Dosage Forms,

Manufacturing Equipment Addendum.’’

This draft guidance is intended to

provide recommendations to

pharmaceutical manufacturers using

CDER’S Guidance for Industry on

‘‘Immediate Release Solid Oral Dosage

Forms, Scale-Up and Post-Approval

Changes: Chemistry, Manufacturing and

Controls, In Vitro Dissolution Testing,

and In Vivo Bioequivalence

Documentation’’ (SUPAC–IR), which

published in November 1995, and

CDER’s Guidance for Industry ‘‘SUPAC–

MR: Modified Release Solid Oral Dosage

Forms Scale-Up and Post-Approval

Changes: Chemistry, Manufacturing and

Controls; In Vitro Dissolution Testing

and In Vivo Bioequivalence

Documentation,’’ which published in

September 1997.

This draft guidance is a revision of the

guidance entitled ‘‘SUPAC–IR:

Immediate Release Solid Oral Dosage

Forms, Manufacturing Equipment

Addendum’’ that published in October

1997, and the draft guidance is intended

to supersede the previously published

guidance. The draft guidance includes

information on equipment used to

manufacture modified release solid oral

dosage form products as well as

immediate release solid oral dosage

form products and may be used to

determine what documentation should

be submitted to FDA regarding

equipment changes made in accordance

with the recommendations in sections V

and VI.A of the SUPAC–IR guidance
23292 Federal Register / Vol. 63, No. 81 /Tuesday, April 28, 1998 / Notices

and in sections VI and VII of the

SUPAC–MR guidance.

This draft guidance represents the

agency’s current thinking on scale-up

and postapproval equipment changes

for immediate release and modified

release solid oral dosage forms regulated

by CDER. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the requirement

of the applicable statute, regulations, or

both.

Interested persons may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: April 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–11197 Filed 4–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0238]

Guidance Document for Industry and

CDRH Staff for the Preparation of

Investigational Device Exemptions and

Premarket Approval Applications for

Bone Growth Stimulator Devices;

Draft; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance Document for

Industry and CDRH Staff for the

Preparation of Investigational Device

Exemptions and Premarket Approval

Applications for Bone Growth

Stimulator Devices.’’ This guidance is

not final or in effect at this time. The

purpose of this document is to suggest

to the device manufacturer or

investigation sponsor important

information which should be presented

in investigational device exemption

(IDE) and premarket approval (PMA)

applications in order to provide

reasonable assurance of the safety and

effectiveness of these devices for their

intended uses.

DATES: Written comments concerning

this guidance must be submitted by July

27, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

draft guidance document entitled

‘‘Guidance Document for Industry and

CDRH Staff for the Preparation of

Investigational Device Exemptions and

Premarket Approval Applications for

Bone Growth Stimulator Devices’’ to the

Division of Small Manufacturers

Assistance, Center for Devices and

Radiological (HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Written

comments concerning this guidance

document must be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments should

be identified with the docket number

found in brackets in the heading of this

document. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John

S. Goode, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION:

I. Background

The preparation of a guidance

document for Bone Growth Stimulator

applications was first initiated by the

Division of Surgical and Rehabilitation

Devices (DSRD) of the Office of Device

Evaluation (ODE) in conjunction with

the Division of Physical Sciences (DPS)

and Life Sciences (DLS) of the Office of

Science and Technology in 1985. The

purpose of the document was to suggest

to the device manufacturer or

investigation sponsor important

information which should be presented

in IDE and PMA applications in order

to provide reasonable assurance of the

safety and effectiveness of these devices

for their intended uses. The document

went through extensive review by

representatives of DSRD, DPS, DLS, the

Orthopedic and Rehabilitation Devices

(ORD) Advisory Panel, and industry

representatives. Comments and

recommendations generated by these

reviews resulted in a revised draft

document, which was presented for

discussion during an open public

session of the ORD Advisory Panel

meeting held on October 31, 1986.

Subsequent to the panel meeting, the

Health Industry Manufacturers

Association organized a task force

which again reviewed the document

and suggested changes to the Center for

Devices and Radiological Health (CDRH)

on February 15, 1988. As a result, a final

guidance document was issued on

August 12, 1988. This revised draft of

the guidance document was initiated in

response to discussions and

correspondences with sponsors of bone

growth stimulator devices and other

interested parties, and it provides

additional guidance detailing the ODE’s

present perspective on issues relating to

these devices. The revised draft

guidance will be considered by the ORD

Advisory Panel in a meeting to be held

on April 28, 1998, at 9200 Corporate

Blvd., Rockville, MD.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on IDE

and PMA applications for Bone Growth

Stimulators. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the applicable

statute, regulations, or both.

The agency has adopted Good

Guidance Practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This draft guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive copies of the draft

guidance document entitled ‘‘Guidance

Document for Industry and CDRH Staff

for the Preparation of Investigational

Device Exemptions and Premarket

Approval Applications for Bone Growth

Stimulator Devices’’ via your fax

machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (487) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance document may also do

so using the World Wide Web (WWW).

CDRH maintains an entry on the WWW

for easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the Web. Updated on a