00-16398. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Environmental Impact Considerations

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 July 31, 2000.

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: Wendy Taylor, 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.

Environmental Impact Considerations—Part 25 (21 CFR Part 25)—(OMB Control Number 0910-0322)—Extension

FDA is requesting OMB approval for the reporting requirements contained in FDA's regulation “Environmental Impact Considerations” (part 25).

The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.

FDA's NEPA regulations are at part 25. All applications or petitions requesting agency action require the submission of an Environmental Assessment (EA) or a claim of categorical exclusion. Section 25.15(a) and (d) specify the procedures for submitting to FDA a claim for a categorical exclusion (certain classes of FDA-regulated actions have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS). Section 25.40(a) and (c) specify the content requirements for EA's for nonexcluded actions.

This collection of information is used by FDA to assess the environmental impact of agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications (when not eligible for categorical exclusion) for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register notice also filed for comment at the Environmental Protection Agency. The final EIS including the comments received is reviewed by the agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact. When the agency finds that no significant environmental effects are expected, the agency prepares a finding of no significant impact (FONSI).

I. Estimated Annual Reporting Burden for Human Drugs

Under 21 CFR 312.23(a)(7)(iv)(e), 21 CFR 314.50(d)(1)(iii), and 21 CFR 314.94(a)(9)(i), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 1998, FDA received 2,427 IND's from 1,874 sponsors, 129 NDA's from 80 applicants, 2,500 supplements to NDA's from 238 applicants, 345 ANDA's from 101 applicants, and 3,713 supplements to ANDA's from 165 applicants. FDA estimates that it receives approximately 9,094 claims for categorical exclusions as required under § 25.15(a) and (d), and 20 EA's as required under § 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA.

Table 1.—Estimated Annual Reporting Burden for Human Drugs ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	2,039	4.46	9,094	8	72,752
25.40(a) and (c)	20	1	20	3,400	68,000
Total					140,752
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

II. Estimated Annual Reporting Burden for Human Foods

Under 21 CFR 71.1, 170.39, and 171.1, food additive petitions, color additive petitions, and requests for exemption from regulation as a food additive must contain a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. In 1998, FDA received 57 food additive petitions, 9 color additive petitions, and 26 threshold of regulation exemption requests. FDA estimates that it received approximately 80 claims of categorical exclusions as required under § 25.15(a) and (d), and 12 EA's as required under § 25.40(a) and (c). FDA estimates that it takes petitioners or requesters approximately 8 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.

Table 2.—Estimated Annual Reporting Burden for Human Foods ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	44	1.8	8.0	8	640
25.40(a) and (c)	11	1.1	12	210	2,520
Total					3,160
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish a premarket notification process as the primary method for authorizing a new use of a food additive that is a food contact substance. Section 409(h)(6) of the act defines a food contact substance as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in food. Under the notification process, FDA must be notified at least 120 days prior to the marketing of a food contact substance. If FDA does not object within 120 days to the use of a food contact substance that is the subject of a notification, the substance may be legally marketed for the notified use. FDA expects that the majority of new uses of food contact substances that will be the subject of premarket notifications would previously have been regulated under the food additive petition process or exempted from the requirement of a regulation under the threshold of regulation process. FDA has provided in a separate Federal Register notice an opportunity for public comment on the collection of information associated with the premarket notification program, including environmental information requirements (64 FR 61648, November 12, 1999).

III. Estimated Annual Reporting Burden for Medical Devices

Under 21 CFR part 814, premarket approvals (original PMA's and supplementals) must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 1998, FDA received 568 claims (original PMA's and supplementals) for categorical exclusions as required under § 25.15(a) and (d), and 0 (zero) EA's as required under § 25.40(a) and (c). Based on information provided by less than 10 sponsors, FDA estimates that it takes approximately less than 1 hour to prepare a claim for a categorical exclusion and an unknown number of hours to prepare an EA.

Table 3.—Estimated Annual Reporting Burden for Medical Devices ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	94	6	568	1	568
25.40(a) and (c)	0	0	0	0	0
Total					568
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. Estimated Annual Reporting Burden for Biological Products

Under 21 CFR 312(a)(7)(iv)(c) and 601.2(a), IND and biologics license applications must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 1998, FDA received 492 IND's from 278 sponsors, 78 license applications from 20 applicants, and 903 supplements to license applications from 190 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.

FDA estimates that it receives approximately 660 claims for categorical exclusion as required under § 25.15(a) and (d), and 2 EA's as required under § 25.40(a) and (c). Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim for categorical exclusion and approximately 3,400 hours to prepare an EA.

Table 4.—Estimated Annual Reporting Burden for Biological Products ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	317	2	660	8	5,280
25.40(a) and (c)	2	1	2	3,400	6,800
Total					12,080
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

V. Estimated Annual Reporting Burden for Animal Drugs

Under 21 CFR 514.1(b)(14) new animal drug applications (NADA's) and abbreviated new animal drug application (ANADA), 514.8(a)(1) supplemental NADA's and ANADA's, 511.1(b)(10) investigational new animal drug applications, 570.35(c)(1)(viii) generally recognized as safe, affirmation petitions, and 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. Since the last OMB approval of the subject collections of information, the Center for Veterinary Medicine has received approximately 545 claims for categorical exclusions as required under § 25.15(a) and (d), and 32 EA's as required under § 25.40(a) and (c). Based on information provided by industry, FDA estimates that it takes sponsors/applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 2,160 hours to prepare an EA.

Table 5.—Estimated Annual Reporting Burden for Animal Drugs ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	194	2.8	545	8	4,360
25.40(a) and (c)	29	1.1	32	2,160	69,120
Total					73,480
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on information provided by industry, FDA estimates that the combined burden for the Environmental Impact Considerations—Part 25 are as follows:

Table 6.—Estimated Annual Reporting Burden for All Centers ¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Burden Hours
25.15(a) and (d)	2,688	17.06	10,875	33	83,600
25.40(a) and (c)	62	4.02	66	9,170	146,440
Total	2,750	21.08	10,941	9,203	230,040
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of March 13, 2000 (65 FR 13405), the agency requested comments on the proposed collections of information. No comments were received.

Dated: June 22, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.