Agency Information Collection Activities: Proposed Collection; Comment Request

SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed reinstatement of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on adverse drug experience

reporting and recordkeeping requirements.

DATES: Submit written comments on the collection of information by

March 2, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should

be identified with the docket number found in brackets in the heading

of this document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information

Resources Management (HFA-250), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed reinstatement of an existing collection of information,

before submitting the collection to OMB

[[Page 67875]]

for approval. To comply with this requirement, FDA is publishing notice

of the proposed collection of information listed below.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Postmarketing Reporting of Adverse Drug Experiences--21 CFR 310.305

and 314.80--(OMB Control Number 0910-0230--Reinstatement)

Sections 201, 502, 505, and 701 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that

marketed drugs be safe and effective. In order to know whether drugs

that are not safe and effective are on the market, FDA must be promptly

informed of adverse experiences occasioned by the use of marketed

drugs. In order to help ensure this, FDA issued regulations in

Secs. 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose

reporting and recordkeeping requirements on the drug industry that

would enable FDA to take actions necessary for protection of the public

health from adverse drug experiences.

All applicants who have received marketing approval of drug

products are required to report to FDA serious, unexpected adverse drug

experiences, as well as followup reports when needed

(Sec. 314.80(c)(1)). This includes reports of all foreign or domestic

adverse experiences as well as those obtained in scientific literature

and from postmarketing epidemiological/surveillance studies. Under

Sec. 314.80(c)(2) applicants must provide periodic reports of adverse

drug experiences. Under Sec. 314.80(i) applicants must keep for 10

years records of all adverse drug experience reports known to the

applicant.

For marketed prescription drug products without approved new drug

applications or abbreviated new drug applications, manufacturers,

packers, and distributors are required to report to FDA serious,

unexpected adverse drug experiences as well as followup reports when

needed (Sec. 310.305(c)(1) and (c)(3)). Under Sec. 310.305(f) each

manufacturer, packer, and distributor shall maintain for 10 years

records of all adverse drug experiences required to be reported.

The primary purpose of FDA's adverse drug experience reporting

system is to provide a signal for potentially serious safety problems

with marketed drugs. Although premarket testing discloses a general

safety profile of a new drug's comparatively common adverse effects,

the larger and more diverse patient populations exposed to the marketed

drug provides, for the first time, the opportunity to collect

information on rare, latent, and long-term effects. Signals are

obtained from a variety of sources, including reports from patients,

treating physicians, foreign regulatory agencies, and clinical

investigators. Information derived from the adverse drug experience

reporting system contributes directly to increased public health

protection because the information enables FDA to make important

changes to the product's labeling (such as adding a new warning) and,

when necessary, to initiate removal of a drug from the market.

Respondents to this collection of information are manufacturers,

packers, distributors and applicants. FDA estimates the burden of this

collection of information as follows:

Table 1.--Estimated Annual Reporting Burden1

----------------------------------------------------------------------------------------------------------------

Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

310.305(c)(5) 1 1 1 1 1

314.80(c)(1)(iii) 5 1 5 1 5

314.80(c)(2) 683 1.5 1,025 5 5,125

Total 5,131

----------------------------------------------------------------------------------------------------------------

\1\ The reporting burden for Secs. 310.305(c)(1)(i), 310.305(c)(3), and 314.80(c)(1)(i) was reported in 0910-

0291. There are no capital costs or operating and maintenance costs associated with this collection of

information.

Table 2.--Estimated Annual Recordkeeping Burden1

----------------------------------------------------------------------------------------------------------------

Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

----------------------------------------------------------------------------------------------------------------

310.305(f) 25 1 25 1 25

314.80(i) 683 1 683 1 683

Total 6,547

----------------------------------------------------------------------------------------------------------------

\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

[[Page 67876]]

These estimates are based on FDA's knowledge of adverse drug

experience reporting, including knowledge about the time needed to

prepare the reports and the number of reports submitted to the agency.

Dated: December 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-33797 Filed 12-29-97; 8:45 am]

BILLING CODE 4160-01-F