Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45665

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

[FR Doc. 97–22861 Filed 8–27–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0496]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by September

29, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Judith V. Bigelow, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1479.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Reporting and Recordkeeping

Requirements for Manufacturers and

Distributors of Electronic Products—21

CFR Parts 1002–1010, FDA Forms 2877,

3147, and 766 (OMB Control Number

0910–0025—Reinstatement)

Sections 532 through 542 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360ii through 360ss)

direct the Secretary of the Department of

Health and Human Services (the

Secretary) to establish and carry out an

electronic product radiation control

program to protect the public from

unnecessary radiation from electronic

products. Such program shall include

the development, issuance, and

administration of performance

standards to control the emission of

electronic product radiation from

electronic products. Section 534(g) of

the act (21 U.S.C. 360kk(g)) directs the

Secretary to review and evaluate

industry testing programs on a

continuing basis, and section 535(e) and

(f) of the act (21 U.S.C. 360ll(e) and (f))

directs the Secretary to immediately

notify manufacturers of, and assure

correction of, radiation defects or

noncompliances with performance

standards. The authority for records and

reports is contained in section 537(b)

and (c) of the act (21 U.S.C. 360nn(b)

and (c)).

The regulations implementing these

statutory provisions are found in parts

1002 through 1010 (21 CFR parts 1002

through 1010). Section 1002.3 requires

manufacturers, when directed by FDA,

to provide technical and safety

information to users. Section 1002.10(a)

through (k) requires manufacturers to

submit to FDA product reports

containing identification, design,

operation and testing, quality control

procedures, test results, and product

labeling prior to the entry of the product

into commerce. Section 1002.11(a) and

(b) requires manufacturers to submit

supplemental reports to FDA if

modifications in product safety or

testing of electronic products affect

actual or potential radiation emission.

Section 1002.12(a) through (e) requires

manufacturers to submit abbreviated

information on product safety and

testing. Section 1002.13(a) through (c)

requires manufacturers to report

annually to FDA a summary of

manufacturer records maintained in

accordance with § 1002.30, and provide

quarterly updates of models instead of

§ 1002.10 or § 1002.11 reports. Section

1002.20(a) through (c) requires

manufacturers to report to FDA the

circumstances, amount of exposure, and

remedial actions taken concerning any

accidental radiation occurrence

involving their electronic products. If a

firm is also required to report the

incident under 21 CFR part 803, those

regulations take precedence. Section

1002.30(a) and (b) requires

manufacturers to keep records on test

data and procedures, correspondence

regarding radiation safety, and

distribution records. Section 1002.31(a)

requires manufacturers to maintain

records required to be kept under part

1002 for 5 years. Section 1002.31(c)

requires manufacturers, when requested

by FDA, to provide copies of the

distribution records required to be

maintained by § 1002.30(b). Section

1002.40(a) through (c) requires dealers

and distributors to retain first purchaser

information, to be used by

manufacturers when a product recall is

instituted to ensure the radiation safety

of a product. Section 1002.41(a) and (b)

specifies that the dealer/distributor

records in § 1002.40 may be retained by

the dealer or forwarded to the

manufacturer for retention and that the

manufacturer or dealer shall retain

distribution records for 5 years. Section

1002.50(a) specifies criteria by which

manufacturers may request exemption

from reporting and recordkeeping

requirements when there is a low risk of

injury, and § 1002.51 specifies criteria

by which manufacturers may request

exemption from reporting and

recordkeeping requirements under

certain circumstances if the product is

intended for U.S. Government use. The

burden is combined with § 1002.50(a),

because the processes and procedures

are identical.

Section 1003.10(a) and (c) requires

manufacturers to notify FDA when their

product has a defect or fails to comply

with applicable performance standards.

Also, under § 1003.10(b) manufacturers

must notify purchasers, dealers, and

distributors of product defects or

noncompliance. Section 1003.11(a)(3)

specifies criteria by which

manufacturers may refute FDA’s notice

of defective or noncompliant product,

and § 1003.11(b) states that

manufacturers, when notified by FDA,

must provide information on the

number of defective products

introduced into commerce. Section

1003.20(a) through (h) specifies

information to be provided by

manufacturers to FDA when the

manufacturer discovers a defect or

failure to comply. Section 1003.21(a)

through (d) specifies the content and

format of the notification by

manufacturers to affected persons

required by § 1003.10(a). Under

§ 1003.22(a) and (b), manufacturers

must provide to FDA copies of the

§ 1003.10 disclosure sent to purchasers

and to dealers or distributors. Section

1003.30(a) and (b) specifies criteria by

which manufacturers may request an

exemption from the § 1003.10 disclosure

and possible product recall and

§ 1003.31(a) and (b) specifies the

content of the § 1003.30 report and the

procedure that the agency will follow in

reviewing exemption requests. Sections

1004.2(a) through (i), 1004.3(a) through

(i), and 1004.4(a) through (h) require

manufacturers to report to FDA every

plan to remedy a product defect or

noncompliance through repair or

replacement or refund.
45666 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

Section 1005.21(a) through (c)

specifies criteria for manufacturers or

importers to request correction of

noncompliant products for importation

into the United States, including

specific corrections, timeframe, and

location for completion. Such requests

are made on Form FDA 766,

Application for Authorization to Relabel

or to perform other action of the act and

other related acts. Section 1005.25(a)

and (b) requires importers to report

identification information and

compliance status of products to FDA.

Initial designations are provided in the

§§ 1002.10, 1002.11, and 1002.12

reports, so that burden is included in

those sections. For each shipment,

identification is made on Form FDA

2877. Form FDA 2877, Declaration for

Products Subject to Radiation Control

Standards, is used to collect this

information.

Part 1010 prescribes performance

standards for electronic products, under

section 534 of the act, to which

manufacturers must certify. Section

1010.2(d) specifies criteria for

manufacturers to request alternate

means of certification to a performance

standard. Section 1010.3(a) through (c)

requires manufacturers to provide to

FDA the coding systems if information

on labels is coded and to identify each

brand name, and the name and address

of the individual or company for whom

each product so branded is

manufactured. Because firms provide

such information in the §§ 1002.10,

1002.11, and 1002.12 reports, the

burden is included in those sections.

Section 1010.4(b) specifies criteria for

manufacturers to petition FDA for a

variance from a performance standard.

Form FDA 3147, Application for a

Variance from 21 CFR 1040.11(c) for

laser light shows, is used only by

manufacturers of laser products to

submit the information. Since the vast

majority of variances are submitted by

this industry, this form was developed

to reduce the burden and timeframe for

approvals. Section 1010.5(c) and (d)

specifies criteria by which

manufacturers or U.S. Government

agencies may request an exemption (or

amendment or extension) from

performance standards when a product

is to be used exclusively by a part of the

U.S. Government and has adequate

radiation emission specifications.

Section 1010.13 provides that

manufacturers may request alternate test

procedures from those specified in a

performance standard. The burden is

combined with § 1010.5(c) and (d)

because the processes and procedures

are identical.

The information collections are

placed upon manufacturers, importers,

assemblers, distributors, and dealers of

electronic products. Not all of the

requirements are placed on all of these

groups. The data reported to FDA and

the records that are maintained are used

by FDA and the industry to make

decisions and take actions that protect

the public from radiation hazards

presented by electronic products. The

reports are reviewed by FDA staff to

determine product safety and adequacy

of quality control testing. Potential and

actual problems are resolved with the

individual firm. Each firm’s quality

control staff reviews the test records to

maintain production of safe and

compliant products. The data provided

to users and others are intended to

encourage actions to reduce or eliminate

radiation exposures.

If FDA did not collect this

information, FDA may not have

sufficient information to take

appropriate actions to protect the public

from unnecessary radiation hazards

presented by electronic products.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours Total Operating andMaintenance Costs

1002.3 10 1 10 12 120 $2,940

1002.10, 1010.3 540 1.6 850 24 20,400 $499,800

1002.11 1,000 1.5 1,500 0.5 750 $18,375

1002.12 150 1 150 5 750 $18,375

1002.13 Annual 900 1 900 26 23,400 $573,300

1002.13 Quarterly 250 2.4 600 0.5 300 $7,350

1002.20 40 1 40 2 80 $1,960

1002.50(a), 1002.51 10 1.5 15 1 15 $367.50

Form FDA 2877 600 32 19,200 0.2 3,840 $94,080

1010.2 1 1 1 5 5 $122.50

1010.4 and Form FDA 3147 53 2.1 115 0.5 58 $1,421

1010.4—Other 1 1 1 120 120 $2,940

1010.5, 1010.13 3 1 3 22 66 $1,617

Totals 1,760 23,385 49,904 $1,222,648

There are no capital costs associated with this collection.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours Total Operating andMaintenance Costs

1002.30, 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505 $5,598,373

1002.40, 1002.41 2,950 49.2 145,140 2.4 7,080 $173,460

Totals 4,100 235,585

There are no capital costs associated with this collection.

These burden estimates are based on

comments from industry and interviews

with industry personnel.

Several requirements are not included

in the burden chart because they are

exempt under 5 CFR 1320.4. These

exempt requirements are: Sections

1002.31(c), 1003.10(a) through (c),

1003.11(a)(3), 1003.11(b), 1003.20(a)
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45667

through (h), 1003.21(a) through (d),

1003.22(a) and (b), 1003.30(a) and (b),

1003.31(a) and (b), 1004.2(a) through (i),

1004.3(a) through (i), 1004.4(a) through

(h) and 1005.21(a) through (c). Other

requirements are not included because

they constitute a disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public

(5 CFR 1320.3(c)(2)).

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22857 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0221]

Benzodiazepines and Related

Substances; Criteria for Scheduling

Recommendations Under the

Controlled Substance Act; Notice of

Public Hearing Modification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) in conjunction

with other Federal agencies is

announcing that the part 15 public

hearing on benzodiazepines and related

substances originally scheduled for

September 11 and 12, 1997, will be held

only on September 11, 1997. The public

hearing will not continue to September

12, 1997. The decision to forego the

second day is based on the limited

number of respondents submitting

notices of participation in the hearing.

DATES: The hearing will be held on

Thursday September 11, 1997, from 9

a.m. to 4 p.m. The closing date for

comments will be October 17, 1997.

ADDRESSES: The public hearing will be

held at the Renaissance Hotel, 999

Ninth St. NW., Washington, DC.

Comments are to be sent to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Transcripts of the public hearing

may be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the hearing, at a cost of 10

cents per page. The transcript of the

public hearing, copies of data and

information submitted during the

hearing, and any written comments will

be available for review at the Dockets

Management Branch (address above)

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Nicholas P. Reuter, Office of Health

Affairs (HFY–20), Food and Drug

Administration, 5600 Fishers Lane, rm.

15–22, Rockville, MD 20857, 301–827–

1696, FAX 301–443– 0232, e-mail

‘‘nreuter@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal

Register of June 19, 1997 (62 FR 33418),

FDA in conjunction with other Federal

agencies announced that it would

convene a part 15 public hearing on

benzodiazepines and related substances.

The public hearing was scheduled for

Thursday, September 11, 1997 and part

of Friday, September 12, 1997.

Persons who wished to participate in

the hearing were asked to file a notice

of participation with the Dockets

Management Branch (address above) on

or before August 14, 1997. In response

to that notice, eight individuals

representing various organizations

indicated their interest in participating

in the hearing. FDA, along with the

other participating agencies, have

determined that the number of

individuals indicating an interest in

participating in the hearing can be

accommodated in one full day and that

there is no need to continue the hearing

to the second day. Therefore, the public

hearing will be held at the address

above from approximately 9 a.m. until

4 p.m. on September 11, 1997.

Interested parties may still sign up to

participate in the hearing. The June 19,

1997, notice included a provision

whereby persons may give oral notice of

participation by calling Nicholas Reuter

(telephone number above) no later than

August 29, 1997. This notice extends

until September 3, 1997, the

opportunity to give oral notice of

participation. Those persons who give

oral notice of participation should also

submit written notice containing the

information described above to the

Dockets Management Branch by the

close of business September 8, 1997.

Dated: August 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22935 Filed 8–25–97; 11:56 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0256]

Norma D. Banks; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Norma D. Banks, 3688 West

Minarets Ave., Fresno, CA 91331, from

providing services in any capacity to a

person that has an approved or pending

drug product application. FDA bases

this order on a finding that Ms. Banks

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Ms. Banks has failed to request a

hearing and, therefore, has waived her

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: August 28, 1997.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Ms. Banks was employed by H. R.

Cenci Laboratories, Inc. (Cenci), as

Director of Quality Assurance and

Regulatory Affairs. In that capacity, on

November 17, 1993, she knowingly and

willfully made false, fictitious, and

fraudulent representations in a matter

within the jurisdiction of FDA.

Specifically, she misrepresented to

FDA’s Office of Generic Drugs

information contained in an annual

report that stability tests for three drug

products manufactured by H. R. Cenci

Laboratories, Inc. (i.e., promethazine

syrup with phenylephrine,

promethazine syrup with codeine, and

promethazine syrup with phenylephrine

and codeine), were uniformly passing,

when, in fact, several stability test

results were failing.

On January 25, 1996, the United

States District Court for the District of

Maryland entered judgment against Ms.