Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 379-382 [E9-31199]
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Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
These estimates are based on FDA’s
experience with previous consumer
studies.
srobinson on DSKHWCL6B1PROD with PROPOSALS
IV. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Schwartz, L., S. Woloshin, W. Black, et
al., The Role of Numeracy in Understanding
the Benefit of Screening Mammography,
Annals of Internal Medicine, 127(11), 966–
72, 1997.
2. Draft Guidance for Industry: Presenting
Risk Information in Prescription Drug and
Medical Device Advertising, available at
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM155480.pdf.
3. Woloshin, S. and L. Schwartz, Direct to
Consumer Advertisements for Prescription
Drugs: What Are Americans Being Told,
Lancet, 358, 1141–46, 2001.
4. Frosch, D.L., P.M. Krueger, R.C. Hornik,
et al., Creating Demand for Prescription
Drugs: A Content Analysis of Television
Direct-to-Consumer Advertising, Annals of
Family Medicine, 5(1), 6–13, 2007.
5. Schwartz, L.M., S. Woloshin, H.G.
Welch, The Drug Facts Box: Providing
Consumers With Simple Tabular Data on
Drug Benefit and Harm, Medical Decision
Making, 27, 655–692, 2007.
6. Schwartz, L.M., S. Woloshin, H.G.
Welch, Communicating Drug Benefits and
Harms Wth a Drug Facts Box: Two
Randomized Trials, Annals of Internal
Medicine, 150, 516–527, 2009.
7. Woloshin, S., L.M. Schwartz, H.G.
Welch, The Value of Benefit Data in Directto-Consumer Drug Ads, Health Affairs, Web
Exclusive Supplement, W4–234–245, 2004.
8. Beyth-Marom, R., How Probable is
Probable? A Numerical Translation of Verbal
Probability Expressions, Journal of
Forecasting, 1, 257–269, 1982.
9. Bowman, M.L., The Perfidity of
Percentiles, Archives of Clinical
Neuropsychology, 17, 295–303, 2002.
10. Cohen, D.J., J.M. Ferrell, N. Johnson,
What Very Small Numbers Mean, Journal of
Experimental Psychology: General, 131, 424–
442, 2002.
11. Fagerlin, A., C. Wang, P.A. Ubel,
Reducing the Influence of Anecdotal
Reasoning on People’s Health Care Decisions:
Is a Picture Worth a Thousand Statistics?,
Medical Decision Making, 25, 398–405, 2005.
12. Lipkus, I., Numeric, Verbal, and Visual
Formats of Conveying Health Tasks:
Suggested Best Practices and Future
Recommendations, Medical Decision Making,
27, 697–713, 2007.
13. Fagerlin, A., P.A. Ubel, D.M. Smith, et
al., Making Numbers Matter: Present and
Future Research in Risk Communication,
American Journal of Health Behavior, 31,
Supplement 1: S47–56, 2007.
14. Ancker, J.S., Y. Senathirajah, R.
Kukafka, et al., Design Features of Graphs in
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Health Risk Communication: A Systematic
Review, Journal of the American Medical
Information Association, 13, 608–618, 2006.
15. Lipkus, I., J.G. Hollands, The Visual
Communication of Risk, Journal of the
National Cancer Institute Monographs, 25,
149–163, 1999.
16. Slovic, P. and E. Peters, Risk Perception
and Affect, Current Directions in
Psychological Science, 15, 322–325, 2006.
17. Slovic, P., J. Monahan, DG MacGregor,
Violence Risk Assessment and Risk
Communication: The Effects of Using Actual
Cases, Providing Instruction, and Employing
Probability Versus Frequency Formats, Law
and Human Behavior, 24, 271–96, 2000.
18. Peters, E., D. Vastfjall, P. Slovic, et al.,
Numeracy and Decision Making,
Psychological Science, 17, 407–13, 2006.
Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–31200 Filed 1–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0372]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February 4,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0322. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
PO 00000
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379
301–796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 ‘‘Environmental
Impact Considerations.’’
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 in 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
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Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
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 (FONSI).
Estimated Annual Reporting Burden for
Human Drugs (Including Biologics in
the Center for Devices and Radiological
Health)
Under § 312.23(a)(7)(iv)(e) (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 2008, FDA received 2,550
INDs from 2,026 sponsors; 106 NDAs
from 88 applicants; 2,856 supplements
to NDAs from 615 applicants; 13
biologics license applications (BLAs)
from 9 applicants; 206 supplements to
BLAs from 64 applicants; 835 ANDAs
from 165 applicants; and 4,143
supplements to ANDAs from 224
applicants. FDA estimates that it
receives approximately 10,689 claims
for categorical exclusions as required
under § 25.15(a) and (d), and 20 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
25.15(a) and (d)
3,171
25.40(a) and (c)
20
Total Annual
Responses
3.37
Hours per
Response
Total Hours
10,686
8
85,488
20
3,400
68,000
1
Total
153,488
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 71.1, 171.1, 170.39, and
170.100, food additive petitions, color
additive petitions, requests for
exemption from regulation as a food
additive, and submission of a food
contact notification for a food contact
substance must contain either a claim of
categorical exclusion under § 25.30 or
§ 25.32, or an EA under § 25.40. In 2008,
FDA received 112 industry submissions.
FDA received an annual average of 67
claims of categorical exclusions as
required under § 25.15(a) and (d), and
45 EAs as required under § 25.40(a) and
(c). FDA estimates that, on average, it
takes petitioners, notifiers, or requestors
approximately 3 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
Responses
Hours per
Response
Total Hours
25.15(a) and (d)
40
1.7
68
3
204
25.40(a) and (c)
24
1.9
45
210
9,450
Total
1 There
9,654
are no capital costs or operating and maintenance costs associated with this collection of information.
srobinson on DSKHWCL6B1PROD with PROPOSALS
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
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§ 25.30 or § 25.34 or an environmental
assessment under § 25.40. In 2008, FDA
received approximately 39 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
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information provided by less than 10
sponsors, FDA estimates that it takes
approximately 6 hours to prepare a
claim for a categorical exclusion and an
unknown number of hours to prepare an
EA.
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Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
25.15(a) and (d)
39
1
39
6
234
25.40(a) and (c)
1
1
1
1
1
Total
235
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Biological Products in the Center for
Biologics Evaluation and Research
Under § 312.23(a)(7)(iv)(e) and 21 CFR
601.2(a), IND and BLAs must contain a
claim for categorical exclusion under
§ 25.30 or § 25.31 or an EA under
§ 25.40. In 2008, FDA received 245 INDs
from 180 sponsors; 28 BLAs from 13
applicants; and 972 BLA supplements to
license applications from 173
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 370 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
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
25.15(a) and (d)
210
25.40(a) and (c)
2
Total Annual
Responses
1.76
Hours per
Response
Total Hours
370
8
2,960
2
3,400
6,800
1
Total
9,760
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for
Animal Drugs
Under 21 CFR 514.1(b)(14), new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs); § 514.8(a)(1)
supplemental NADAs and ANADAs;
§ 511.1(b)(10) investigational new
animal drug applications (INADs); 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. In 2008, FDA’s Center for
Veterinary Medicine has received
approximately 676 claims for categorical
exclusion as required under § 25.15(a)
and (d), and 8 EAs as required under
§ 25.40(a) and (c). FDA estimates that it
takes sponsors/applicants
approximately 5 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
Responses
Hours per
Response
Total Hours
25.15(a) and (d)
65
10.4
676
5
3,380
25.40(a) and (c)
6
1.3
8
2,160
17,280
Total
1 There
20,660
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 6.—COMBINED ESTIMATED ANNUAL TOTAL BURDEN HOURS FOR ALL CENTERS
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Total
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Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
In the Federal Register of September
9, 2009 (74 FR 46430), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–31199 Filed 1–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSKHWCL6B1PROD with PROPOSALS
Proposed Collection; Comment
Request; Process Evaluation of the
NIH’s Roadmap Interdisciplinary
Research Work Group Initiatives
SUMMARY: In compliance with the
requirements of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of the Director, the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: The National
Institute of Dental and Craniofacial
Research of the National Institutes of
Heath requests a three-year clearance for
the ‘‘Process Evaluation of the NIH
Roadmap Interdisciplinary Research
Work Group Initiatives,’’ a new
collection. This study will be used to
determine whether the NIH’s
Interdisciplinary Research Work Group
initiatives have been, and are being,
conducted as planned, whether the
expected outputs are being produced,
and how the activities and processes
associated with the initiatives can be
improved. Information collected during
the evaluation will be used to assess
whether and how these initiatives
differed from existing initiatives to
determine whether these unique
initiatives or mechanisms are necessary,
to make decisions about whether to
continue and/or to modify the programs,
and to make decisions about structural
or procedural changes within NIH that
may be necessary to support crosscutting interdisciplinary programs. The
frequency of response is once for most
respondents, and twice for a limited
group. The affected public includes a
limited number of individuals; Type of
respondents: principal investigators,
other grant investigators, and Initiative
trainees. The annual reporting burden is
as follows: Estimated number of
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respondents: 450; Estimated number of
responses per respondent: PIs, 2; Other
Investigators, 1; Trainees, 1; Average
burden hours per response: 30 minutes;
and Estimated total annual burden
hours requested: 250 hours. The total
annualized cost to respondents
(calculated as the number of
respondents * frequency of response *
average time per response *
approximate hourly wage rate) is
estimated to be $4,565.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Sue Hamann,
Ph.D., Science Evaluation Officer, Office
of Science Policy Officer and Analysis,
NIDCRD, NIH. You may reach Dr.
Hamann by telephone on 301–594–4849
(this is not a toll-free number), or you
may e-mail your request to Dr. Hamann
at Sue.Hamann@nih.hhs.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: December 22, 2009.
Sue Hamann,
Science Evaluation Officer, OSPA, NIDCR,
National Institutes of Health.
[FR Doc. E9–31234 Filed 1–4–10; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–10–0004]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Acting
Reports Clearance Officer, 1600 Clifton
Road NE., MS–D74, Atlanta, Georgia
30333; comments may also be sent by
e-mail to omb@cdc.gov.
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
National Disease Surveillance
Program II. Disease Summaries (0920–
0004 Exp. 5/31/2010)—Revision—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID)
(proposed), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Surveillance of the incidence and
distribution of disease has been an
important function of the U.S. Public
Health Service (PHS) since 1878.
Through the years, PHS/CDC has
formulated practical methods of disease
control through field investigations. The
CDC National Disease Surveillance
Program is based on the premise that
diseases cannot be diagnosed,
prevented, or controlled until existing
knowledge is expanded and new ideas
developed and implemented. Over the
years, the mandate of CDC has
broadened to include preventive health
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]]>Agencies
[Federal Register Volume 75, Number 2 (Tuesday, January 5, 2010)]
[Notices]
[Pages 379-382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31199]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0372]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 4, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0322.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
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--21 CFR Part 25--OMB Control Number
0910-0322)--Extension
FDA is requesting OMB approval for the reporting requirements
contained in the FDA regulation ``Environmental Impact
Considerations.''
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 in 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 (Sec. 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
[[Page 380]]
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 (FONSI).
Estimated Annual Reporting Burden for Human Drugs (Including Biologics
in the Center for Devices and Radiological Health)
Under Sec. 312.23(a)(7)(iv)(e) (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 Sec. 25.30 or Sec. 25.31 or an EA under Sec. 25.40.
In 2008, FDA received 2,550 INDs from 2,026 sponsors; 106 NDAs from 88
applicants; 2,856 supplements to NDAs from 615 applicants; 13 biologics
license applications (BLAs) from 9 applicants; 206 supplements to BLAs
from 64 applicants; 835 ANDAs from 165 applicants; and 4,143
supplements to ANDAs from 224 applicants. FDA estimates that it
receives approximately 10,689 claims for categorical exclusions as
required under Sec. 25.15(a) and (d), and 20 EAs as required under
Sec. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden for Human Drugs\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and 3,171 3.37 10,686 8 85,488
(d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and 20 1 20 3,400 68,000
(c)
----------------------------------------------------------------------------------------------------------------
Total 153,488
----------------------------------------------------------------------------------------------------------------
\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 71.1, 171.1, 170.39, and 170.100, food additive
petitions, color additive petitions, requests for exemption from
regulation as a food additive, and submission of a food contact
notification for a food contact substance must contain either a claim
of categorical exclusion under Sec. 25.30 or Sec. 25.32, or an EA
under Sec. 25.40. In 2008, FDA received 112 industry submissions. FDA
received an annual average of 67 claims of categorical exclusions as
required under Sec. 25.15(a) and (d), and 45 EAs as required under
Sec. 25.40(a) and (c). FDA estimates that, on average, it takes
petitioners, notifiers, or requestors approximately 3 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 40 1.7 68 3 204
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 24 1.9 45 210 9,450
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 9,654
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Sec. 25.30 or Sec. 25.34 or an environmental assessment under
Sec. 25.40. In 2008, FDA received approximately 39 claims (original
PMAs and supplements) for categorical exclusions as required under
Sec. 25.15(a) and (d), and 0 EAs as required under Sec. 25.40(a) and
(c). Based on information provided by less than 10 sponsors, FDA
estimates that it takes approximately 6 hours to prepare a claim for a
categorical exclusion and an unknown number of hours to prepare an EA.
[[Page 381]]
Table 3.--Estimated Annual Reporting Burden for Medical Devices\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and 39 1 39 6 234
(d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and 1 1 1 1 1
(c)
----------------------------------------------------------------------------------------------------------------
Total 235
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Biological Products in the Center
for Biologics Evaluation and Research
Under Sec. 312.23(a)(7)(iv)(e) and 21 CFR 601.2(a), IND and BLAs
must contain a claim for categorical exclusion under Sec. 25.30 or
Sec. 25.31 or an EA under Sec. 25.40. In 2008, FDA received 245 INDs
from 180 sponsors; 28 BLAs from 13 applicants; and 972 BLA supplements
to license applications from 173 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 370 claims for
categorical exclusion as required under Sec. 25.15(a) and (d), and 2
EAs as required under Sec. 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 Products\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
25.15(a) and 210 1.76 370 8 2,960
(d)
----------------------------------------------------------------------------------------------------------------
25.40(a) and 2 1 2 3,400 6,800
(c)
----------------------------------------------------------------------------------------------------------------
Total 9,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Reporting Burden for Animal Drugs
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); Sec. 514.8(a)(1)
supplemental NADAs and ANADAs; Sec. 511.1(b)(10) investigational new
animal drug applications (INADs); and Sec. 571.1(c) food additive
petitions must contain a claim for categorical exclusion under Sec.
25.30 or Sec. 25.33 or an EA under Sec. 25.40. In 2008, FDA's Center
for Veterinary Medicine has received approximately 676 claims for
categorical exclusion as required under Sec. 25.15(a) and (d), and 8
EAs as required under Sec. 25.40(a) and (c). FDA estimates that it
takes sponsors/applicants approximately 5 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 Drugs\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d) 65 10.4 676 5 3,380
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c) 6 1.3 8 2,160 17,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 20,660
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 6.--Combined Estimated Annual Total Burden Hours for All Centers
------------------------------------------------------------------------
------------------------------------------------------------------------
Total 193,797
------------------------------------------------------------------------
[[Page 382]]
In the Federal Register of September 9, 2009 (74 FR 46430), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31199 Filed 1-4-10; 8:45 am]
BILLING CODE 4160-01-S
