03-6228. Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA regulations entitled “Environmental Impact Considerations.”

DATES:

Submit written or electric comments on the collection of information by May 16, 2003.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​edockethome.cfm. Submit written comments on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen 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 extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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.

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

FDA is requesting OMB approval for the reporting requirements contained in the FDA regulation entitled “Environmental Impact Considerations.”

The National Environmental Policy Act of 1969 (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 (21 CFR part 25). All applications or petitions requesting agency action require the submission of a claim for a categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) specifies the content requirements for EAs 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 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 document 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. Any final EIS would contain additional information gathered by the agency after the publication of the draft EIS, a copy of or a summary of the comments received on the draft EIS, and the agency's responses to the comments, including any revisions resulting from the comments or other information. When the agency finds that no significant environmental effects are expected, the agency prepares a finding of no significant impact.

Estimated Annual Reporting Burden for Human Drugs

Under 21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 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 2002, FDA received 2,374 INDs from 1,809 sponsors, 109 NDAs from 79 applicants, 2,575 supplements to NDAs from 276 applicants, 392 ANDAs from 107 applicants, and 3,343 supplements to ANDAs from 222 applicants. FDA estimates that it receives approximately 8,771 claims for categorical exclusions as required under § 25.15(a) and (d) and 22 EAs 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 Drugs¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	Hours per Response	Total Burden Hours
25.15(a) and (d)	2,031	4.32	8,771	8	70,168
25.40(a) and (c)	22	1	22	3,400	74,800
Total					144,968
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Human Foods

Under 21 CFR 171.1, 71.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests for exemption from regulation as a food additive, and submission of a premarket notification for a food contact substance must contain a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. In 2002, FDA received 12 food additive petitions and 106 food contact substance notifications. FDA estimates that it received approximately 87 claims of categorical exclusions as required under § 25.15(a) and (d) and 31 EAs as required under § 25.40(a) and (c). FDA estimates that it takes petitioners or requestors 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 Foods¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	Hours per Response	Total Burden Hours
25.15(a) and (d)	56	1.6	87	4	348
25.40(a) and (c)	18	1.7	31	210	6,510
Total					6,858
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Medical Devices

Under 21 CFR 814.20(b)(11), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for categorical exclusion under § 25.30 or §25.34 or an EA under § 25.40. In 1998, FDA received 568 claims (original PMAs and supplements) for categorical exclusions as required under § 25.15(a) and (d), and 0 EAs 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 Devices¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	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.

Estimated Annual Reporting Burden for Biological Products

Under 21 CFR 312.23(a)(7)(iv)(e) and 601.2(a), IND and biologics license applications (BLAs) must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 2001, FDA received 535 INDs from 376 sponsors, 80 BLAs from 22 applicants, and 837 BLA supplements to license applications from 168 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 received approximately 699 claims for categorical exclusion as required under § 25.15(a) and (d), and 2 EAs 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 for a biological product.

Table 4.—Estimated Annual Reporting Burden for Biological Products¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	Hours per Response	Total Burden Hours
25.15(a) and (d)	415	1.68	699	8	5,592
25.40(a) and (c)	2	1	2	3,400	6,800
Total					12,392
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and ANADAs, 514.8(a)(1), supplemental NADAs and ANADAs, 511.1(b)(10) investigational new animal drug applications (INADs), 570.35(c)(1)(viii) generally recognized as safe (GRAS) affirmation petitions, and 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or § 25.33 or an EA under § 25.40. Since the last OMB approval of these collections of information, FDA's Center of Veterinary Medicine has received approximately 547 claims for categorical exclusion as required under § 25.15(a) and (d) and 19 EAs 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 an average of 2,160 hours to prepare an EA.

Table 5.—Estimated Annual Reporting Burden for Animal Drugs¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	Hours per Response	Total Burden Hours
25.15(a) and (d)	139	3.9	549	8	4,392
25.40(a) and (c)	14	1.4	19	2,160	41,040
Total					45,432
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 is as follows:

Table 6.—Total Estimated Annual Reporting Burden For All Centers¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Records	Hours per Response	Total Burden Hours
25.15(a) and (d)	70,168	348	568	5,592	76,676
25.40(a) and (c)	74,800	6,510	0	6,800	88,110
Total					164,786

Dated: March 10, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.