68 FR 45 pgs. 11119-11120 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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Type: NOTICEVolume: 68Number: 45Pages: 11119 - 11120

Docket number: [Docket No. 02N-0452]

FR document: [FR Doc. 03-5357 Filed 3-6-03; 8:45 am]

Agency: Health and Human Services Department

Sub Agency: Food and Drug Administration

Official PDF Version: PDF Version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0452]

Agency Information Collection Activities; Submission for OMB Review; Comment Request; New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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.

DATES:

Submit written comments on the collection of information by April 7, 2003.

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, Attn: Stuart Shapiro, Desk Officer for FDA.

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:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

FDA has amended its new drug and biological product regulations to allow appropriate studies in animals in certain cases to provide substantial evidence of effectiveness of new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers and field trials are not feasible prior to approval. In these circumstances, when it may be impossible to demonstrate effectiveness through adequate and well-controlled studies in humans, FDA is providing that certain new drug and biological products intended to treat or prevent serious or life-threatening conditions could be approved for marketing based on studies in animals, without the traditional efficacy studies in humans. FDA is taking this action because it recognizes the importance of improving medical responses capabilities to the use of lethal or permanently disabling chemical, biological, radiological, and nuclear substances in order to protect individuals exposed to these substances.

Respondents to this information collection are business and other for-profit organizations, and nonprofit institutions.

FDA estimates the burden of this collection of information as follows:

21 CFR Section	No. of -Respondents	Annual Frequency per Response	Total Annual -Responses	Hours per -Response	Total Hours
314.610(b)(2), 314.630, 601.91(b)(2), and 601.93	1	1	1	5	5
314.610(b), 314.640, 601.91(b), and 601.94	1	1	1	240	240
Total					245
¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

21 CFR Section	No. of -Recordkeepers	Annual Frequency of Recordkeeping	Total Annual Records	Hours per -Recordkeeper	Total Hours
314.610(b)(2), 314.630, 601.91(b)(2), and 601.93	1	1	1	1	1
314.610(b), and 601.91(b)	1	1	1	1	1
Total					2
¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that only one application of this nature may be submitted every 3 years, however, for calculation purposes. FDA is estimating the submission of one application annually. FDA estimates 240 hours for a manufacturer of a new drugs or biological product to develop patient labeling and to submit the appropriate information and promotional labeling to FDA. At this time, FDA cannot estimate the number of postmarketing reports for information collection. These reports are required under 21 CFR parts 310, 314, and 600. Any requirements will be reported under the adverse experience reporting (AER) information collection requirements. The estimated hours for postmarketing reports range from 1 to 5 hours based on previous estimates for AER; however, FDA is estimating 5 hours for the purpose of this information collection.

The majority of the burden for developing the patient labeling is included under the reporting requirements; therefore, minimal burden is calculated for providing the guide to patients. As discussed previously, no burden can be calculated at this time for the number of AER reports that may be submitted after approval of a new drug or biologic. Therefore, the number of records that may be maintained also cannot be determined. Any burdens associated with these requirements will be reported under the AER information collection requirements. The estimated recordkeeping burden of 1 hour is based on previous estimates for the recordkeeping requirements associated with the AER system.

FDA, in the Federal Register of November 13, 2002 (67 FR 68874), the agency requested comments on the proposed collection of information. No comments were received.

Dated: February 28, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.

[FR Doc. 03-5357 Filed 3-6-03; 8:45 am]

BILLING CODE 4160-01-S