50952 Federal Register / Vol. 62, No. 188 / Monday, September 29, 1997 / Notices

Field name Comments

Record Identifier .................................................. Enter ‘T4’ for W4 data.

Enter ‘TQ’ for Quarterly Wage data.

Enter ‘TU’ for Unemployment Insurance data.

Data Record Count ............................................. Enter the total number of records transmitted in this data set, including the header and trailer

records. This will be used to verify that all records are received and processed.

Filler .................................................................... Spaces. To be used for future versions of the system.

Data Record

Each of the data records for W4, Quarterly Wage, and UI is different in several ways. Following is further explanation

of some of the data elements in those record layouts. See the Record Layout specifications for detailed information

on all data elements.

Field name Comments

Record Identifier .................................................. Enter ‘W4’ for the W4 record.

Enter ‘QW’ for the Quarterly Wage record.

Enter ‘UI’ for the Unemployment Insurance record.

Foreign Address Data Elements ......................... If an address supplied for the employee or employer is outside the United States, include the

Foreign Country Code for the address, the Foreign Country Name, and the Foreign Zip

Code.

Employee Wage Amount (QW) .......................... For Quarterly Wage data, provide the gross amount paid to the employee during the quarter,

regardless of when the amount was earned.

Reporting Period ................................................. Use the quarters that correspond to the calendar year rather than quarters that correspond to

fiscal accounting periods. Use the format QYYYY where:

Q = 1 for January–March.

Q = 2 for April–June.

Q = 3 for July–September.

Q = 4 for October–December.

Benefit Amount (UI) ............................................ The UI Benefit Amount is the gross amount paid within the reporting quarter before any withholding offsets are applied. This amount should be the sum of benefits received from all

programs tracked electronically by the State. However, only include those benefits that are

housed in the same hardware environment. Do not include benefits from sources that must

be translated or imported to the mainframe environment.

Output Records

FPLS will return records to the data

transmitters when errors were detected.

The states can elect to have these

records returned for error resolution or

not as they choose. Federal agencies,

however, will receive all error records

from each transmittal.

The record formats for the error

records are identical to the input record

provided by the submitter except that

error codes will be appended that

explain the nature of the error. Errors

can occur at the transmission level and

at the individual record level.

Transmission Control Records: This is

the output equivalent of the input

TRANSMITTER RECORD and includes

counts of records received, records

rejected, error records returned, records

posted to the National Director of New

Hires, records posted to the Suspense

File, and up to five Error Codes

pertaining to the transmission level

error conditions encountered.

Data Records: Each output version of

the input DATA RECORD had appended

to it up to five record level error codes

that indicate the nature of the error

encountered during editing. It also

contains a Social Security Number

Verification Indicator that indicates

whether multiple valid SSNs were

encountered during the SSN verification

process. In addition, a corrected SSN is

returned if during the SSN verification

process the supplied SSN was

determined to be incorrect and the

verification procedure was able to

provide the correct SSN.

Total Records: No transmission total

records will be returned to the

submitting State or federal agency.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

In addition, comments may also be

forwarded to ACF at the following

address: The Administration for

Children and Families, Office of

Information Services, Division of

Information Resources, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Attn: Reports Clearance Officer,

Internet address:

rjdriscoll@acf.dhhs.gov.

Dated: September 23, 1997.

Robert Driscoll,

Reports Clearance Officer.

[FR Doc. 97–25769 Filed 9–26–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0389]

FDA Approval of Animal Drugs for

Minor Uses and Minor Species; Draft

Guidance Document; Availability;

Request for Comments

AGENCY: Food and Drug Administration,

HHS.
Federal Register / Vol. 62, No. 188 / Monday, September 29, 1997 / Notices 50953

ACTION: Notice of availability; request

for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment on a draft

Level 1 guidance document entitled

‘‘FDA Approval of Animal Drugs for

Minor Uses and for Minor Species.’’ The

guidance document defines minor

species and minor uses and sets forth

suggestions for generating safety and

effectiveness data to support the

approval of minor use and minor

species drugs. The draft Level 1

guidance document sets forth

substantive changes in policy that

warrant input from affected parties.

DATES: Submit written comments on the

draft guidance document by December

29, 1997.

ADDRESSES: Submit written comments

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 full title

of the draft guidance document and the

docket number found in brackets in the

heading of this document.

Submit written requests for single

copies of the draft guidance document

to the Communications and Education

Team (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Oeller, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1650. Email: moeller@bangate.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA’s draft guidance document

entitled ‘‘FDA Approval of Animal

Drugs for Minor Uses and for Minor

Species,’’ is a Level 1 guidance

document by definition in the Good

Guidance Practices (62 FR 8961,

February 27, 1997). This notice of

availability for comment should not be

confused with the Federal Register

document of June 23, l997 (62 FR

33781), entitled ‘‘Request for Comments

on Development of Options to

Encourage Animal Drug Approvals for

Minor Species and for Minor Uses,’’

which dealt with the same subject

matter but was issued to seek comment

and suggestions on legislative and

regulatory options which could be

utilized if adopted in the future to

facilitate approval of new animal drugs

for minor uses and minor species.

This draft, when finalized, will

replace the previous guidance entitled

‘‘Guidelines for the Preparation of Data

to Satisfy the Requirements of Section

512 of the Act Regarding Minor Use of

Animal Drugs,’’ (guidelines) dated April

1986. In the Federal Register of May 30,

l986 (51 FR 19612), FDA issued a notice

of availability of the guidelines. No

comments were received on the

guidelines. A previous version of the

draft guidance document was made

available in November 1996 to

interested parties who requested a copy.

The draft guidance document suggests

procedures that could be used to

demonstrate the safety and efficacy of a

minor use animal drug. Minor use

animal drugs are defined as: (1) New

animal drugs used in minor animal

species or (2) new animal drugs used in

any animal species for the control of a

disease that occurs infrequently or in

limited geographic areas. ‘‘Minor

species’’ are defined by regulation as

animals other than cattle, horses, swine,

chickens, turkeys, dogs, and cats.

According to current regulations, sheep

are a minor species except with respect

to human food safety data collection

requirements, for which sheep are

considered a major species. FDA

intends to issue a proposed regulation

in which sheep would be considered a

minor species for all requirements of the

drug approval process.

The procedures set forth in the draft

guidance document for demonstrating

the safety and efficacy of a minor use

animal drug apply to production drugs

as well as therapeutic drugs.

The draft guidance document has

been organized in two parts. Part 1

includes general information on the

document, an overview of the approval

process, data extrapolation, advice on

working with the Center for Veterinary

Medicine (CVM), and definitions. Part 2

presents specific options for satisfying

data requirements for minor uses in

major species, minor avian species

(gamebirds, semi-domestic waterfowl,

and ratites), minor ruminants (goats,

bison, semi-domestic deer), rabbits, and

aquatic species (finfish, aquatic

invertebrates, alligators, etc.). Each

section in part 2 contains information

on efficacy, target animal safety, human

food safety, and environmental data

requirements. The major data

components, excluding manufacturing

chemistry, of the animal drug approval

process are represented in part 2.

When finalized, the draft guidance

document will represent the agency’s

current thinking on the means of

generating efficacy and safety data to

support approval of new animal drug

applications for minor use of new

animal drugs. This draft guidance

document will not create or confer any

rights for or on any person and will not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Request for Comments

Interested persons may, on or before

December 29, 1997, submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance document. 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, and with the

full title of the guidance document. The

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. After

review of these comments, FDA will

implement the guidance document with

any appropriate changes. Thereafter,

interested persons may submit written

comment on the guidance document

directly to the CVM Communications

and Education Team (address above).

III. Electronic Access

A copy of the draft guidance

document may be obtained from the

CVM Home Page (http://

www.cvm.fda.gov) on the Internet.

Dated: September 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25667 Filed 9–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0282]

General Principles of Software

Validation; Draft Guidance; Extension

of the Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

December 30, 1997, the comment period

for the notice announcing the

availability of a draft guidance entitled

‘‘General Principles of Software

Validation’’ that published in the

Federal Register of July 25, 1997 (62 FR