	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0930; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;
Attainment Demonstration for the Philadelphia-Wilmington-Atlantic City

Moderate 8-Hour Ozone Nonattainment Area

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to disapprove the ozone attainment
demonstration portion of a comprehensive State Implementation Plan (SIP)
revision submitted by the State of Delaware to meet the Clean Air Act
(CAA) requirements for attaining the 8-hour ozone national ambient air
quality standard (NAAQS) for the Delaware portion of the
Philadelphia-Wilmington-Atlantic City moderate nonattainment area
(Philadelphia Area).  EPA is proposing to disapprove Delaware’s
attainment demonstration of the 8-hour ozone NAAQS for the Philadelphia
Area because EPA has determined that the photochemical modeling does not
demonstrate attainment, and the weight of evidence analysis that
Delaware uses to support the attainment demonstration does not provide
the sufficient evidence that the Delaware portion of the Philadelphia
nonattainment area will attain the NAAQS by the June 2010 deadline.

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2008-0930 by one of the following methods:

A.  www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.  E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.  Mail:  EPA-R03-OAR-2008-0930, Cristina Fernandez, Chief, Air Quality
Planning Branch, Mailcode 3AP21, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.  Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2008-0930.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.  Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov or
e-mail.  The www.regulations.gov website is an (anonymous access(
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment.  If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.  Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.  Copies of the State submittal
are available at the Delaware Department of Natural Resources &
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I.  What Action is EPA Proposing?

II.  What are the CAA Requirements for a Moderate 8-Hour Ozone
Nonattainment Area?

	A.  History and Time Frame for the State's Attainment Demonstration SIP

B.  CAA Requirements

III.  What was Included in Delaware’s SIP Submittal?

IV.  What is EPA's Review of Delaware’s Modeled Attainment
Demonstration and Weight of Evidence (WOE) Analysis for the Delaware
portion of the Philadelphia Area?

V.  What are the Consequences of a Disapproved SIP?

A.  What are the CAA's Provisions for Sanctions?

B.  What are the CAA's Federal Implementation Plan (FIP) Ramifications
if a State Fails to Submit an Approvable Plan?

C.  What are the Ramifications Regarding Conformity?

VI.  What is EPA's Conclusion?

VII.  Statutory and Executive Order Reviews

	A.  Executive Order 12866, Regulatory Planning and Review

	B.  Paperwork Reduction Act

	C.  Regulatory Flexibility Act

	D.  Unfunded Mandates Reform Act

	E.  Executive Order 13132, Federalism

	F.  Executive Order 13175, Coordination with Indian Tribal Governments

	G.  Executive Order 13045, Protection of Children from Environmental
Health Risks and Safety Risks

	H.  Executive Order 13211, Actions that Significantly Affect Energy
Supply, Distribution, or Use

I.  National Technology Transfer and Advancement Act

	J.  Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations

I.  What Action is EPA proposing?

EPA is proposing to disapprove the SIP revision consisting of the 8-hour
ozone attainment demonstration plan for the Philadelphia-Wilmington-
Atlantic City moderate nonattainment area, submitted by the Delaware
Department of Natural Resources and Environmental Control (DNREC) on
June 13, 2007.

EPA is proposing to disapprove Delaware’s 8-hour ozone attainment
demonstration plan because EPA has determined that the photochemical
modeling does not demonstrate attainment, and the weight of evidence
analysis that Delaware uses to support the attainment demonstration does
not provide the sufficient evidence that the Delaware portion of the
Philadelphia nonattainment area will attain the NAAQS by the June 2010
deadline.

EPA’s analysis and findings are discussed in this proposed rulemaking
and a more detailed discussion is contained in the Technical Support
Document (TSD) for this proposal which is available on line at
HYPERLINK "www.regulations.gov"  www.regulations.gov , Docket number
EPA-R03-OAR-2008-0930.

II.  What are the CAA Requirements for a Moderate 8-Hour Ozone
Nonattainment Area?

A.  History and Time Frame for the State's Attainment Demonstration SIP

In 1997, EPA revised the health-based NAAQS for ozone, setting it at
0.08 parts per million (ppm) averaged over an 8-hour time frame
(“8-hour ozone standard”).  EPA set the 8-hour ozone standard based
on scientific evidence demonstrating that ozone causes adverse health
effects at lower ozone concentrations, and over longer periods of time,
than was understood when the pre-existing 1-hour ozone standard was set.
 EPA determined that the 8-hour standard would be more protective of
human health, especially children and adults who are active outdoors,
and individuals with a pre-existing respiratory disease, such as asthma.

On April 30, 2004 (69 FR 23951), EPA finalized its
attainment/nonattainment designations for areas across the country with
respect to the 8-hour ozone standard.  These actions became effective on
June 15, 2004.  In addition, EPA promulgated its Phase 1 Rule for
implementation

of the 8-hour standard, which provided how areas designated
nonattainment for the 8-hour ozone standard would be classified. April
30, 2004 (69 FR 23951).  Among those nonattainment areas is the
Philadelphia Area.  The Philadelphia Area includes three counties in
Delaware, five counties in eastern Pennsylvania, one county in Maryland,
and eight counties in southern New Jersey.  The Delaware portion of the
NAA consists of the following counties:  New Castle, Kent and Sussex.
EPA’s Phase 2 8-hour ozone implementation rule, published on  November
29, 2005 (70 FR 71612) specifies that states must submit attainment
demonstrations for their nonattainment areas to the EPA by no later than
three years from the effective date of designation, that is, by June 15,
2007.  See, 40 CFR 51.908(a).

B.  CAA Requirements

Pursuant to Phase 1 of the 8-hour ozone implementation rule, published
on April 30, 2004 (69 FR 23951), an area was classified under subpart 2
of Title I of the CAA based on its 8-hour design value if it had a
1-hour design value at or above 0.121 ppm.  Based on this criterion, the
Philadelphia Area was classified under subpart 2 as moderate
nonattainment areas.  On November 29, 2005 (70 FR 71612), EPA published
Phase 2 of the 8-hour ozone implementation rule in which it addresses
the control obligations that apply to areas classified under subpart 2.
Among other things, the Phase 1 and 2 rules outline the SIP requirements
and deadlines for various requirements in areas designated as moderate
nonattainment.

III.  What was Included in Delaware’s SIP Submittals?

On June 13, 2007, Delaware submitted a comprehensive 8-hour ozone SIP.
The SIP submittal included an attainment demonstration plan, a
reasonable further progress (RFP) plan, reasonably available control
measures analysis, contingency measures, on-road motor vehicle emission
budgets, and the 2002 base year emissions inventory.  These SIP
revisions were subject to notice and comment by the public.  The State
did not receive any comments on the proposed SIP revisions.  Only the
attainment demonstration sections of this SIP submittal are the subject
in this rulemaking.  The other sections of this SIP submittal will be
addressed in a separate rulemaking.

IV. What is EPA's Review of Delaware’s Modeled Attainment
Demonstration and Weight of Evidence (WOE) Analysis for the Delaware
portion of the Philadelphia Area?

Section 110(a)(2)(K) of the Clean Air Act requires states to prepare air
quality modeling to show how they will meet ambient air quality
standards.  EPA determined that states must use photochemical grid
modeling, or any other analytical method determined by the Administrator
to be at least as effective, to demonstrate attainment of the ozone
health-based standard in areas classified as ‘moderate’ or above,
and to do so by the required attainment date.  See, 40 CFR 51.908(c).
EPA specified how areas would be classified with regard to the 8-hour
ozone standard set by EPA in 1997.  See, 40 CFR 51.903.  EPA followed
these procedures and the Philadelphia Area was classified by EPA as
being in moderate nonattainment of the 8-hour ozone NAAQS.  See, 69 FR
23858 (April 30, 2004).  The attainment date is June 2010 for moderate
areas; therefore, states must achieve emission reductions by the ozone
season of 2009 in order for ozone concentrations to be reduced, and
attainment achieved during the last complete ozone season before the
2010 deadline.

As more fully described in the TSD, the basic photochemical grid
modeling used by Delaware in the Delaware SIP meets EPA’s guidelines,
and when used with the methods recommended in EPA’s modeling guidance,
is acceptable to EPA.  EPA’s photochemical modeling guidance is found
at Guidance on the Use of Models and Other Analyses for Demonstrating
Attainment of Air Quality Goals for Ozone, PM2.5, and Regional Haze,
EPA-454/B-07-002, April 2007.  Using EPA’s methods, the photochemical
grid model, containing the modeled emission reduction strategies
prepared by Delaware and the Ozone Transport Commission states, predicts
that the 2009 ozone design value in the Philadelphia Area would be 91
parts per billion (ppb).  Thus, the photochemical model predicts the
Philadelphia Area will not reach the 84 ppb concentration level needed
to show attainment of the ozone standard by the 2009 ozone season.

EPA’s photochemical modeling guidance is divided into two parts.  One
part describes how to use a photochemical grid model for ozone to assess
whether an area will come into attainment of the air quality standard.
The second part of EPA’s photochemical modeling guidance strongly
recommends states complement the photochemical air quality modeling with
additional analyses (WOE analyses) in situations where modeling predicts
the Philadelphia Area to be close to (within several parts per billion
of) the ozone standard.  A WOE analysis is any set of alternative
methods or analyses that, when considered together, and in combination
with the modeling analysis, supports the conclusion that the NAAQS has
been attained, even in instances when the modeling results alone do not
predict attainment.  EPA notes in Section 2.3 of its guidance that if
the concentration predicted by the photochemical model is 88 ppb or
higher, it is “far less likely that the more qualitative arguments
made in a weight of evidence determination can be sufficiently
convincing to conclude that the NAAQS will be attained.”

The Philadelphia Area photochemical grid modeling predicts a 2009
projected design value well above the air quality health standard (91
ppb vs. 84 ppb).  As stated above, EPA’s photochemical modeling
guidance indicates that it is difficult to make a convincing argument to
show that ozone will be less than 84 ppb when model predicted
concentrations are greater than 88 ppb.  Delaware needed to supply a
substantial amount of evidence that the model is seriously
overestimating future ozone concentrations.  As discussed in detail in
the TSD at pages 8 through 17, EPA believes that modeling and air
quality studies do not support an argument that the attainment will be
reached by the June 2010 attainment date

Additionally, the present air quality (2007 design value 93 ppb, 2008
preliminary design value 92 ppb) also does not support the hypothesis
presented in Delaware’s WOE analysis that the models are incorrect.
Present air quality concentrations should be closer to the standard
since the Philadelphia Area is only two years away from its attainment
deadline.

The WOE analysis presented in the Delaware SIP revision for the
Philadelphia Area includes the following:

a comparison of predicted 2009 ozone design values and current projected
design values for 2006;

an analysis of recent ozone trends in the Philadelphia Area;

alternative methods for calculating the 2009 ozone design value;

an analysis of model-predicted regional transport; and

an analysis of model sensitivity to emission changes

The basic premise of all of the WOE arguments in the Delaware SIP
revision for the Philadelphia Area is that the Community Multi-scale Air
Quality Model version 4.4 (CMAQ), when applied according to EPA
guidance, under-predicts the reduction in ozone that can be expected
from the emission control strategies contained in the SIP.

The overarching reason why EPA is not persuaded that the WOE results are
robust enough to predict that the Philadelphia Area will attain the
standard is that the information and calculations provided in the
Delaware SIP revision selectively emphasize methods or data that support
the claim that the nonattainment areas could attain the standard by the
deadline, while ignoring equally legitimate methods that would tend to
support the modeling results that do not predict attainment.  For
example, one of Delaware’s methods of adjusting the modeled results
uses alternative ways of calculating the base air quality value for
2002.  The Delaware SIP revision for the Philadelphia Area uses a
straight five-year average of the fourth-highest design value from 2000
to 2004.  EPA’s modeling guidance recommends using an average of the
three years of design value centered on 2002, which creates a weighted
five-year average.  While Delaware’s SIP revision notes that EPA’s
method of providing a weighted average baseline value weights the base
year of 2002 more heavily than other years, EPA intended this, so that
the resulting value was influenced the most by the ozone data from the
base year of the emission inventory.  There are other ways of
calculating a baseline value that the State did not use.  For example,
for the peak ozone site of the Philadelphia Area at Colliers Mills:

the EPA guideline method baseline is 105.7 ppb;

the Delaware alternative baseline is 104 ppb;

the 2002 design value is 112 ppb; and

the 2003 designation design value, centered on 2002, is 105.7 ppb.

Various methods could result in 2002’s base year ozone of two ppb
lower than the modeling guidance method (Delaware’s five year average
centered on 2002) or as much as 7 ppb higher than the guidance method
(single design value from 2002).  Delaware relies on the lower end of
the range of possible results, and this brings the modeling result
closer to attainment.

The “sufficiently convincing”  WOE analysis our guidance suggests is
needed when an area’s design value is above 88 ppb, should not be
based  on a one-sided consideration of only those  alternatives that
tend to show that and area will attain the ozone standard.  To be
“sufficiently convincing,” the WOE should evaluate other reasonable
variations on EPA’s methods that reinforce the modeling results that
predict the Philadelphia Area will not attain the ozone standard by
2010.  Although Delaware has provided a WOE analysis it believes
supports its case of attainment in 2010, EPA’s evaluation, as set
forth at length in the TSD, concludes that the WOE does not demonstrate
that the proposed adjustments to the photochemical grid model’s
attainment year forecast will give a more accurate answer than the
calculations based on EPA’s recommendations in Section 2.3 and 7.2 of
its modeling guidance..

In general, EPA’s conclusions concerning the modeled attainment
demonstration and WOE analysis provided in the Delaware SIP revision for
its portion of the Philadelphia Area can be summarized from the TSD as
follows:

The modeling used in the Philadelphia Area applies an appropriate
photochemical grid model and follows EPA’s guidance methods, but does
not predict attainment in June 2010.

Regardless of the issues raised by Delaware regarding the performance of
EPA’s recommended air quality models, the air quality measured during
2007 exceeded the ozone standard by a significant margin.  Even a linear
comparison of the percentage of additional emission reductions planned
by the state with the needed improvement in air quality between 2007 and
2009 indicates it is unlikely that air quality will improve enough to
meet the ozone standard by 2010.  Preliminary data from the 2008 ozone
season also does not support demonstration of attainment by June 2010.

When comparing the measured ozone concentrations in 2007 and
(preliminary) 2008 data to concentrations predicted for 2009, using
EPA’s recommended application of the photochemical grid modeling, the
photochemical grid model does not exhibit the magnitude of inaccuracies
suggested in the Delaware SIP revision.

In order to insure attainment, Delaware suggests that there are
additional measures that can achieve emission reductions which were not
included in the original photochemical modeling analysis.  However, the
amount of potential air quality benefit from these measures is difficult
to estimate with any degree of certainty.  Based on EPA’s evaluation
of the potential ozone benefits these additional measures may provide
for the Philadelphia Area, attainment of the ozone standard in 2010
cannot be achieved through the adoption of these measures.

The Philadelphia Area attainment demonstration greatly relied on
adjustments to the baseline assumptions which formed the basis of the
photochemical modeling analysis. These adjustments to the base year
starting value and the amount of reduction in ozone from 2002 to 2009
differ from EPA’s modeling guidance, and, more importantly, are not
sufficiently justified and are weighted toward a conclusion that
Philadelphia Area will attain the standard.

The Philadelphia Area attainment demonstration greatly relied on
research which evaluated the impact of a widespread power blackout to
develop an alternative approach to estimating anticipated air quality
improvements from upwind power plants.  W While EPA believes that this
approach provides some insight into the transport of ozone precursors, a
critical review of all the research available to EPA leads EPA to
disagree with Delaware’s premise that the 2009 modeled design values
should be adjusted downward for alleged model under-predictions of ozone
concentration reductions from emission reductions.

A detailed discussion of the EPA’s evaluation of the modeled
attainment demonstration and WOE analysis contained in the Delaware SIP
for the Philadelphia Area is located in the TSD entitled, Technical
Support Document for the Modeling and Weight of Evidence (WOE) Portions
of the State of Delaware’s Ozone State Implementation Plan (SIP)
Entitled “Delaware State Implementation Plan for Attainment of the
8-Hour Ozone National Ambient Air Quality Standard Reasonable Further
Progress and Attainment Demonstration, June 2007.”

EPA has carefully evaluated the information provided by Delaware and
other information it deems relevant to help predict what the air quality
is likely to be by the 2009 ozone season. After careful consideration of
all the relevant information, EPA finds that there is not sufficiently
convincing evidence that the Philadelphia Area will attain the 8-hour
ozone NAAQS in 2010.  The Delaware SIP revision for the Delaware portion
of the Philadelphia Area does not satisfy the Clean Air Act requirement
that State Implementation Plans provide for attainment of the NAAQS by
the applicable attainment date of June 2010.

V.  What are the Consequences of a Disapproved SIP?

This section explains the consequences of a disapproval of a SIP under
the CAA.  The CAA provides for the imposition of sanctions and the
promulgation of a Federal Implementation Plan (FIP) if states fail to
submit a plan that corrects any deficiencies identified by EPA in its
disapproval.

A.  What are the CAA Provisions for Sanctions?

If EPA disapproves a required SIP or component of a SIP for an area
designated nonattainment, such as the Attainment Demonstration SIP,
section 179(a) provides for the imposition of sanctions unless the
deficiency is corrected within 18 months of the final rulemaking of
disapproval.  The first sanction would apply 18 months after EPA
disapproves the SIP if a State fails to make the required submittal
which EPA proposes to fully or conditionally approve within that time.
Under EPA's sanctions regulations, 40 CFR 52.31, the first sanction
would be 2:1 offsets for sources subject to the new source review
requirements under section 173 of the CAA.  If the State has still
failed to submit a SIP for which EPA proposes full or conditional
approval 6 months after the first sanction is imposed, the second
sanction will apply.  The second sanction is a limitation on the receipt
of Federal highway funds.

B.  What are the CAA's FIP Ramifications if a State Fails to Submit an
Approvable Plan?

In addition to sanctions, if EPA finds that a State failed to submit the
required SIP revision or disapproves the required SIP revision, or a
portion thereof, EPA must promulgate a FIP no later than 2 years from
the date of the finding if the deficiency has not been corrected within
that time period.

C.  What are the Ramifications Regarding Conformity?

One consequence of EPA’s disapproval of a control strategy SIP is a
conformity freeze whereby affected Metropolitan Planning Organizations
(MPOs) cannot make new conformity determinations on long range
transportation plans and transportation improvement programs (TIPs).  If
we finalize the disapproval of the attainment demonstration SIP, a
conformity freeze will be in place as of the effective date of the
disapproval without a protective finding of the budget.  See, 40 CFR
93.120(a)(2). This means that no transportation plan, TIP, or project
not in the first four years of the currently conforming transportation
plan and TIP or that meet the requirements of 40 CFR 93.104(f) during a
12-month lapse grace period may be found to conform until another
attainment demonstration SIP is submitted and the motor vehicle
emissions budgets are found adequate or the attainment demonstration is
approved.  In addition, if the highway funding sanction is implemented,
the conformity status of the transportation plan and TIP will lapse on
the date of implementation of the highway sanctions. During a conformity
lapse, only projects that are exempt from transportation conformity
(e.g., road resurfacing, safety projects, reconstruction of bridges
without adding travel lanes, bicycle and pedestrian facilities,

etc.), transportation control measures that are in the approved SIP and
project phases that were approved prior to the start of the lapse can
proceed during the lapse.  No new project-level

approvals or conformity determinations can be made and no new
transportation plan or TIP may be found to conform until another
attainment demonstration SIP is submitted and the motor vehicle
emissions budget is found adequate.

VI.  What is EPA's Conclusion?

EPA is proposing to disapprove the 8-hour ozone attainment demonstration
plan for the Delaware portion of the Philadelphia Area submitted by
Delaware on June 13, 2007, because Delaware’s attainment demonstration
(modeling results and WOE) for the Delaware portion of the Philadelphia
Area does not demonstrate with sufficiently convincing evidence that the
Philadelphia Area will attain the NAAQS by the June 2010 deadline.  EPA
is deferring action at this time on other SIP elements submitted by
Delaware that are related to the attainment demonstration, specifically,
the RFP plan, reasonably available control measures analysis,
contingency measures, on-road motor vehicle emission budgets, and the
2002 base year emissions inventory, which will be addressed in separate
rulemakings.  EPA is soliciting public comments on the issues discussed
in this document.  These comments will be considered before taking final
action.

VII.  Statutory and Executive Order Reviews

A.  Executive Order 12866, Regulatory Planning and Review

This action is not a “significant regulatory action” under the terms
of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO.

B.  Paperwork Reduction Act

This action does not impose an information collection burden under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq,
because this proposed SIP disapproval under section 110 and subchapter
I, part D of the Clean Air Act will not in-and-of itself create any new
information collection burdens but simply disapproves certain State
requirements for inclusion into the SIP.  Burden is defined at 5 CFR
1320.3(b).

C.  Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency to
conduct a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements unless the agency certifies that the
rule will not have a significant economic impact on a substantial number
of small entities.  Small entities include small businesses, small
not-for-profit enterprises, and small governmental jurisdictions.  For
purposes of assessing the impacts of today's rule on small entities,
small entity is defined as: (1) a small business as defined by the Small
Business Administration’s (SBA) regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a government of a city, county,
town, school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not dominant
in its field.

After considering the economic impacts of today’s proposed rule on
small entities, I certify that this action will not have a significant
impact on a substantial number of small entities. This rule does not
impose any requirements or create impacts on small entities.  This
proposed SIP disapproval under section 110 and subchapter I, part D of
the Clean Air Act will not in-and-of itself create any new requirements
but simply disapproves certain State requirements for inclusion into the
SIP.  Accordingly, it affords no opportunity for EPA to fashion for
small entities less burdensome compliance or reporting requirements or
timetables or exemptions from all or part of the rule.  The fact that
the Clean Air Act prescribes that various consequences (e.g., higher
offset requirements) may or will flow from this disapproval does not
mean that EPA either can or must conduct a regulatory flexibility
analysis for this action. Therefore, this action will not have a
significant economic impact on a substantial number of small entities.

We continue to be interested in the potential impacts of this proposed
rule on small entities and welcome comments on issues related to such
impacts.

D.  Unfunded Mandates Reform Act

This action contains no Federal mandates under the provisions of Title
II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector.”  EPA has determined that the proposed disapproval action does
not include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector.  This action proposes to disapprove
pre-existing requirements under State or local law, and imposes no new
requirements.  Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.

E.  Executive Order 13132, Federalism

Executive Order 13132, entitled “Federalism” (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.”
 “Policies that have federalism implications” is defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.”

This action does not have federalism implications.  It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, because it merely disapproves
certain State requirements for inclusion into the SIP and does not alter
the relationship or the distribution of power and responsibilities
established in the Clean Air Act.  Thus, Executive Order 13132 does not
apply to this action.

F.  Executive Order 13175, Coordination with Indian Tribal Governments

This action does not have tribal implications, as specified in Executive
Order 13175 (65 FR 67249, November 9, 2000), because the SIP EPA is
proposing to disapprove would not apply in Indian country located in the
state, and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.  Thus, Executive Order 13175
does not apply to this action.

G.  Executive Order 13045, Protection of Children from Environmental
Health Risks

and Safety Risks

EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only
to those regulatory actions that concern health or safety risks, such
that the analysis required under section 5-501 of the EO has the
potential to influence the regulation.  This action is not subject to EO
13045 because it because it is not an economically significant
regulatory action based on health or safety risks subject to Executive
Order 13045 (62 FR 19885, April 23, 1997).  This proposed SIP
disapproval under section 110 and subchapter I, part D of the Clean Air
Act will not in-and-of itself create any new regulations but simply
disapproves certain State requirements for inclusion into the SIP.

H.  Executive Order 13211, Actions that Significantly Affect Energy
Supply,

Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001) because it is not a significant regulatory action under
Executive Order 12866.

I.  National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of
1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies.  NTTAA directs EPA to provide
Congress, through the Office of Management and Budget, explanations when
the Agency decides not to use available and applicable voluntary
consensus standards.

EPA believes that this action is not subject to requirements of Section
12(d) of NTTAA because application of those requirements would be
inconsistent with the Clean Air Act.

J.  Executive Order 12898: Federal Actions to Address Environmental
Justice in

Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal
executive policy on environmental justice.  Its main provision directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations and low-income populations in the
United States.

EPA lacks the discretionary authority to address environmental justice
in this proposed action.  In reviewing SIP submissions, EPA’s role is
to approve or disapprove state choices, based on the criteria of the
Clean Air Act.  Accordingly, this action merely proposes to disapproves
certain State requirements for inclusion into the SIP under section 110
and subchapter I, part D of the Clean Air Act and will not in-and-of
itself create any new requirements.  Accordingly, it does not provide
EPA with the discretionary authority to address, as appropriate,
disproportionate human health or environmental effects, using
practicable and legally permissible methods, under Executive Order
12898.

In addition, this proposed rule pertaining to the Delaware 8-hour ozone
attainment demonstration plan, does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide,
Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

Authority: 42 U.S.C. 7401 et seq.

____January 9, 2009____________        __/S/__________________________

Dated:                                                      Donald S.
Welsh,

Regional Administrator,

                                                                 Region
III.

 In 2008, EPA promulgated a more stringent 8-hour standard of 0.075 ppm.
 73 FR 16436 (March 27, 2008).  All references to the 8-hour ozone
standard in this rulemaking refer to the 8-hour standard promulgated in
1997.

 Additional information on the implementation of the lapse grace period
can be found in the final transportation conformity rule published on
January 24, 2008, (73 FR 4423-4425).

 PAGE

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[Federal Register: April 19, 2007 (Volume 72, Number 75)]
[Notices]
[Page 19731]
[DOCID:fr19ap07-63]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 15a-4; SEC File No. 270-7; OMB Control No. 3235-0010.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 15a-4 (17 CFR 240.15a-4) under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.) (the ``Exchange Act'') permits a natural
person member of a securities exchange who terminates his or her
association with a registered broker-dealer to continue to transact
business on the exchange while the if the exchange files a statement
indicating that there does not appear to be any ground for disapproving
the application. The total annual burden imposed by Rule 15a-4 is
approximately 106 hours, based on approximately 25 responses (25
Respondents x 1 Response/Respondent), each requiring approximately 4.23
hours to complete.
    The Commission uses the information disclosed by applicants in Form
BD: (1) To determine whether the applicant meets the standards for
registration set forth in the provisions of the Exchange Act; (2) to
develop a central information resource where members of the public may
obtain relevant, up-to-date information about broker-dealers, municipal
securities dealers and government securities broker-dealers, and where
the Commission, other regulators and SROs may obtain information for
investigatory purposes in connection with securities litigation; and
(3) to develop statistical information about broker-dealers, municipal
securities dealers and government securities broker-dealers. Without
the information disclosed in Form BD, the Commission could not
effectively implement policy objectives of the Exchange Act with
respect to its investor protection function.
    The statement submitted by the exchange assures the Commission that
the applicant, in the opinion of the exchange, is qualified to transact
business on the exchange during the time that the applications are
reviewed.
    Written 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 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 clarity 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 automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Comments should be directed to: R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send
an e-mail to<EMAIL_ADDRESS>Comments must be submitted within
60 days of this notice.

    Dated: April 11, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-7421 Filed 4-18-07; 8:45 am]

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[Federal Register: October 12, 2010 (Volume 75, Number 196)]
[Notices]
[Page 62534]
[DOCID:fr12oc10-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD11-1-000]

Reliability Monitoring, Enforcement and Compliance Issues; Notice
of Technical Conference

October 1, 2010.
    The Federal Energy Regulatory Commission (Commission) will hold a
Commissioner-led Technical Conference in the above-referenced
proceeding to explore issues associated with reliability monitoring,
enforcement and compliance, as announced in the Commission's order
issued September 16, 2010 that accepted the North American Electric
Reliability Corporation's initial assessment in Docket No. RR09-7-000
of its performance as the nation's Electric Reliability Organization
(ERO), and performance by the Regional Entities, under their delegation
agreements with the ERO.\1\
---------------------------------------------------------------------------

    \1\ North American Electric Reliability Corporation; Reliability
Standards Development and NERC and Regional Entity Enforcement, 132
FERC ] 61,217 at P 12 (2010).
---------------------------------------------------------------------------

    This Technical Conference will be held on November 18, 2010, in the
Commission Meeting Room (2C) at Commission Headquarters, 888 First
Street, NE., Washington, DC 20426, from 1 p.m. until 5 p.m. EST. The
conference will be transcribed and Webcast. Transcripts of the
conference will be immediately available for a fee from Ace-Federal
Reporters, Inc.<PHONE_NUMBER> or 1-800-336-6646). A free webcast of the
conference is also available through http://www.ferc.gov. Anyone with
Internet access who desires to listen to this event can do so by
navigating to http://www.ferc.gov's Calendar of Events and locating
this event in the Calendar. The event will contain a link to its
webcast. The Capitol Connection provides technical support for the
webcasts and offers the option of listening to the meeting via phone-
bridge for a fee. If you have any questions, visit http://
www.CapitolConnection.org or call<PHONE_NUMBER>.
    A further notice with detailed information, including the agenda,
will be issued in advance of the conference. All interested parties are
invited and there is no registration list or registration fee to
attend.
    For further information contact Gregory Campbell by e-mail at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25505 Filed 10-8-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Notices]
[Pages 22401-22402]
[FR Doc No: 2010-9744]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0265; FRL-8822-8]

Petition from Pesticide Poisoning Victims United; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of a January 25, 2010
petition from Pesticide Poisoning Victims United, a division of the
Pitchfork Rebellion. The petitioners, who reside in Lane County,
Oregon, ask the Agency to undertake a number of actions to protect
potentially affected individuals from pesticides in their area.

DATES: Comments must be received on or before June 28, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0265, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0265. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other

contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jill Bloom, Pesticide Re-evaluation
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a timber
producer, pesticide applicator, or believe you may be affected by
pesticide drift.
     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI (Confidential Business Information). Do not
submit this information to EPA through regulations.gov or e-mail.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is announcing availability of a petition from Pesticide
Poisoning Victims United, a Division of the Pitchfork Rebellion under
docket ID number EPA-HQ-2010-0265.

List of Subjects

    Environmental Protection, Pesticides, and Pests.

    Dated: April 19, 2010.
Peter Caulkins,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-9744 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Notices]
[Pages 10582-10587]
[FR Doc No: 2021-03434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6931]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practices and Related
Regulations for Blood and Blood Components; and Requirements for
Donation Testing, Donor Notification, and ``Lookback''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 collection of information
requirements relating to FDA's regulation of current good manufacturing
practice (CGMP) and related regulations for blood and blood components;
and requirements for donation testing, donor notification, and
``lookback''.

DATES: Submit either electronic or written comments on the collection
of information by April 23, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 23, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6931 for ``Current Good Manufacturing Practices and Related
Regulations for Blood and Blood Components; and Requirements for
Donation Testing, Donor Notification, and `Lookback'.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 these topics: (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.

Current Good Manufacturing Practices and Related Regulations for Blood
and Blood Components; and Requirements for Donation Testing, Donor
Notification, and ``Lookback''

OMB Control Number 0910-0116--Extension

    This information collection supports Agency regulations. All blood
and blood components introduced or delivered for introduction into
interstate commerce are subject to section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that
manufacturers of biological products, which include blood and blood
components intended for further manufacturing into products, have a
license, issued upon a demonstration that the product is safe, pure,
and potent and that the manufacturing establishment meets all
applicable standards, including those prescribed in the FDA regulations
designed to ensure the continued safety, purity, and potency of the
product. In addition, under section 361 of the PHS Act (42 U.S.C. 264),
by delegation from the Secretary of Health and Human Services, FDA may
make and enforce regulations necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States or possessions, or from one State or possession into
any other State or possession.
    Section 351(j) of the PHS Act states that the Federal Food, Drug,
and Cosmetic Act (FD&C Act) also applies to biological products. Blood
and blood components for transfusion or for further manufacturing into
products are drugs, as that term is defined in section 201(g)(1) of the
FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are
drugs under the FD&C Act, blood and plasma establishments must comply
with the provisions and related regulatory scheme of the FD&C Act. For
example, under section 501 of the FD&C Act (21 U.S.C. 351(a)), drugs
are deemed ``adulterated'' if the methods used in their manufacturing,
processing, packing, or holding do not conform to CGMP and related
regulations.
    The CGMP regulations (part 606) (21 CFR part 606) and related
regulations implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. The public health
objective in testing human blood donations for evidence of relevant
transfusion-transmitted infections and in notifying donors is to
prevent the transmission of relevant transfusion-transmitted
infections. For example, the ``lookback'' requirements are intended

to help ensure the continued safety of the blood supply by providing
necessary information to consignees of blood and blood components and
appropriate notification of recipients of blood components that are at
increased risk for transmitting human immunodeficiency virus (HIV) or
hepatitis C virus (HCV) infection.
    The information collection requirements in the CGMP, donation
testing, donor notification, and ``lookback'' regulations provide FDA
with the necessary information to perform its duty to ensure the
safety, purity, and potency of blood and blood components. These
requirements establish accountability and traceability in the
processing and handling of blood and blood components and enable FDA to
perform meaningful inspections.
    The recordkeeping requirements serve preventive and remedial
purposes. The third-party disclosure requirements identify various
blood and blood components and important properties of the product,
demonstrate that the CGMP requirements have been met, and facilitate
the tracing of a product back to its original source. The reporting
requirements inform FDA's Center for Biologics Evaluation and Research
(CBER) of certain information that may require immediate corrective
action.
    Respondents to this collection of information are licensed and
unlicensed blood establishments that collect blood and blood
components, including Source Plasma and Source Leukocytes, inspected by
FDA, and transfusion services inspected by Centers for Medicare and
Medicaid Services (CMS). Based on information received from CBER's
database systems, there are approximately 864 licensed Source Plasma
establishments and approximately 1,789 licensed blood collection
establishments, for an estimated total of 2,653 (864 + 1,789) licensed
blood collection establishments. Also, there are an estimated total of
817 unlicensed, registered blood collection establishments for an
approximate total of 3,470 collection establishments (864 + 1,789 + 817
= 3,470 establishments). Of these establishments, approximately 856
perform plateletpheresis (777) and leukapheresis (79). These
establishments annually collect approximately 73.7 million units of
Whole Blood and blood components, including Source Plasma and Source
Leukocytes, and are required to follow FDA ``lookback'' procedures. In
addition, there are another estimated 4,961 establishments that fall
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
(formerly referred to as facilities approved for Medicare
reimbursement) that transfuse blood and blood components.
    The following reporting and recordkeeping estimates are based on
information provided by industry, CMS, and FDA experience. Based on
information from industry, we estimate that there are approximately
53.5 million donations of Source Plasma from approximately 2.5 million
donors and approximately 12.3 million donations of Whole Blood and
apheresis Red Blood Cells including approximately 10,000 (approximately
0.081 percent of 12.3 million) autologous donations, from approximately
9 million donors. Assuming each autologous donor makes an average of
1.1 donations, FDA estimates that there are approximately 9,090
autologous donors (10,000 autologous/1.1 average donations).
    FDA estimates that approximately 0.53 percent (56,000 / 10,654,000)
of the 77,000 donations that are donated specifically for the use of an
identified recipient would be tested under the dedicated donors'
testing provisions in Sec.  610.40(c)(1)(ii).
    Under Sec. Sec.  610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes,
a licensed product that is used in the manufacture of interferon, which
requires rapid preparation from blood, is currently shipped prior to
completion of testing for evidence of relevant transfusion-transmitted
infections. Shipments of Source Leukocytes are approved under a
biologics license application and each shipment does not have to be
reported to the Agency. Based on information from CBER's database
system, FDA receives less than one application per year from
manufacturers of Source Leukocytes. However, for calculation purposes,
we are estimating one application annually.
    According to CBER's database system, there are approximately 15
licensed manufacturers that ship known reactive human blood or blood
components under Sec. Sec.  610.40(h)(2)(ii)(C) and (D). FDA estimates
that each manufacturer would ship an estimated 1 unit of human blood or
blood components per month (12 per year) that would require two labels;
one as reactive for the appropriate screening test under Sec.
610.40(h)(2)(ii)(C), and the other stating the exempted use
specifically approved by FDA under Sec.  610.40(h)(2)(ii)(D).
    Based on information received from industry, we estimate that
approximately 7,500 donations that test reactive by a screening test
for syphilis and are determined to be biological false positives by
additional testing annually. These units would be labeled according to
Sec.  610.40(h)(2)(vi).
    Human blood or a blood component with a reactive screening test, as
a component of a medical device, is an integral part of the medical
device, e.g. a positive control for an in vitro diagnostic testing kit.
It is usual and customary business practice for manufacturers to
include on the container label a warning statement indicating that the
product was manufactured from a donation found to be reactive for the
identified relevant transfusion-transmitted infection(s). In addition,
on the rare occasion when a human blood or blood component with a
reactive screening test is the only component available for a medical
device that does not require a reactive component, then a warning
statement must be affixed to the medical device. To account for this
rare occasion under Sec.  610.42(a), we estimate that the warning
statement would be necessary no more than once a year.
    FDA estimates that approximately 3,100 repeat donors will test
reactive on a screening test for HIV. We also estimate that an average
of three components was made from each donation. Under Sec. Sec.
610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,300 (3,100 x
3) notifications of the HIV screening test results to consignees by
collecting establishments for the purpose of quarantining affected
blood and blood components, and another 9,300 (3,100 x 3) notifications
to consignees of subsequent test results.
    We estimate that approximately 4,961 consignees will be required
under Sec.  610.46(b)(3) to notify transfusion recipients, their legal
representatives, or physicians of record an average of 0.35 times per
year resulting in a total number of 1,755 (585 confirmed positive
repeat donors x 3) notifications. Also, under Sec.  610.46(b)(3), we
estimate and include the time to gather test results and records for
each recipient and to accommodate multiple attempts to contact the
recipient.
    Furthermore, we estimate that approximately 6,800 repeat donors per
year would test reactive for antibody to HCV. Under Sec. Sec.
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would
notify the consignee 2 times for each of the 20,400 (6,800 x 3
components) components prepared from these donations, once for
quarantine purposes and again with additional HCV test results for a
total of 40,800 (2 x 20,400) notifications as an annual ongoing burden.
Under Sec.  610.47(b)(3), we estimate that approximately 4,961
consignees would notify approximately

2,050 recipients or their physicians of record annually.
    Based on industry estimates, approximately 18.15 percent of
approximately 14,018,000 million potential donors (2,544,000 donors)
who come to donate annually are determined not to be eligible for
donation prior to collection because of failure to satisfy eligibility
criteria. It is the usual and customary business practice of
approximately 2,606 (1,789 + 817) blood collecting establishments to
notify onsite and to explain why the donor is determined not to be
suitable for donating. Based on such available information, we estimate
that two-thirds (1,737) of the 2,606 blood collecting establishments
provided onsite additional information and counseling to a donor
determined not to be eligible for donation as usual and customary
business practice. Consequently, we estimate that only approximately
one-third, or 869 of the 2,606 blood collecting establishments would
need to provide, under Sec.  630.40(a), additional information and
onsite counseling to the estimated 848,000 (one-third of approximately
2,544,000) ineligible donors.
    It is estimated that another 0.6 percent of 14,018,000 potential
donors (84,108 donors) are deferred annually based on test results. We
estimate that approximately 95 percent of the establishments that
collect 99 percent of the blood and blood components notify donors who
have reactive test results for HIV, Hepatitis B Virus, HCV, Human T-
Lymphotropic Virus, and syphilis as usual and customary business
practice. Consequently, 5 percent of the 2,653 licensed establishments
(133) collecting 1 percent (841) of the deferred donors (84,108) would
notify donors under Sec.  630.40(a).
    As part of usual and customary business practice, collecting
establishments notify an autologous donor's referring physician of
reactive test results obtained during the donation process required
under Sec.  630.40(d)(1). However, we estimate that approximately 5
percent of the 1,789 blood collection establishments (89) may not
notify the referring physicians of the estimated 2 percent of 10,000
autologous donors with the initial reactive test results (200) as their
usual and customary business practice.
    The recordkeeping chart reflects the estimate that approximately 95
percent of the recordkeepers, which collect 99 percent of the blood
supply, have developed standard operating procedures (SOPs) as part of
their customary and usual business practice. Establishments may
minimize burdens associated with CGMP and related regulations by using
model standards developed by industries' accreditation organizations.
These accreditation organizations represent almost all registered blood
establishments.
    Under Sec.  606.160(b)(1)(ix), we estimate the total annual records
based on the approximately 2,544,000 donors determined not to be
eligible to donate and each of the estimated 2,628,108 (2,544,000 +
84,108) donors deferred based on reactive test results for evidence of
infection because of relevant transfusion-transmitted infections. Under
Sec.  606.160(b)(1)(xi), only the 1,789 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 9,090
autologous donors (409) will be deferred under Sec.  610.41, which in
turn will lead to the notification of their referring physicians.
    Under Sec.  610.41(b), FDA estimates that there would be 25
submissions for requalification of donors each requiring 7 hours per
submission. In addition, FDA estimates that there would be only 3
notifications for requalification of donors under Sec.  630.35(b) which
would also require 7 hours for each submission.
    FDA permits the shipment of untested or incompletely tested human
blood or blood components in rare medical emergencies and when
appropriately documented (Sec.  610.40(g)(1)). We estimate the
recordkeeping under Sec.  610.40(g)(1) to be minimal with one or fewer
occurrences per year. The reporting of test results to the consignee in
Sec.  610.40(g) is part of the usual and customary business practice of
blood establishments.
    The average burden per response (hours) and average burden per
recordkeeping (hours) are based on estimates received from industry or
FDA experience with similar reporting or recordkeeping requirements.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
606.170(b)\2\; Donor or                       81               1              81              20           1,620
 recipient fatality reporting...
610.40(g)(2); Application for                  1               1               1               1               1
 approval to ship...............
610.41(b); Request for                     2,653          0.0094              25               7             175
 requalification of donor.......
610.40(h)(2)(ii)(A); Application               1               1               1               1               1
 for approval for shipment or
 use............................
630.35(b); Request for                     2,653         0.00113               3               7              21
 requalification of donor.......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,818
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The reporting requirement in Sec.   640.73, which addresses the reporting of fatal donor reactions, is
  included in the estimate for Sec.   606.170(b).

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            21 CFR section; activity                Number of      records per    Total annual      Average  burden per  recordkeeping      Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(b); \2\ Maintenance of SOPs............         \5\ 422               1             422  24.....................................          10,128
606.100(c); Records of investigations..........         \5\ 422              10           4,220  1......................................           4,220
606.110(a); \3\ Documentation donor's health             \6\ 43               1              43  0.5 (30 minutes).......................              22
 permits plateletpheresis or leukapheresis.
606.151(e); Records of emergency transfusions..         \5\ 422              12           5,064  0.08 (5 minutes).......................             405

606.160; \4\ Records of collection, processing,         \5\ 422         907.583         383,000  0.75 (45 minutes)......................         287,250
 compatibility testing, storage, and
 distribution of each unit of blood and blood
 components.
606.160(b)(1)(viii); HIV consignee notification           1,789         10.4533          18,701  0.17 (10 minutes)......................           3,179
                                                          4,961          3.6537          18,126  0.17 (10 minutes)......................           3,081
606.160(b)(1)(viii); HCV consignee notification           1,789         22.8060          40,800  0.17 (10 minutes)......................           6,936
                                                          4,961          8.2241          40,800  0.17 (10 minutes)......................           6,936
HIV recipient notification.....................           4,961          0.3538           1,755  0.17 (10 minutes)......................             298
HCV recipient notification.....................           4,961          0.4132           2,050  0.17 (10 minutes)......................             349
606.160(b)(1)(ix); Donor notification records..           3,470         757.380       2,628,109  0.05 (3 minutes).......................         131,405
606.160(b)(1)(xi); Physician notification                 1,789          0.2286             409  0.05 (3 minutes).......................            20.5
 records.
606.165; Distribution and receipt records......         \5\ 422         907.583         383,000  0.08 (5 minutes).......................          30,640
606.170(a); Adverse reaction records...........         \5\ 422              12           5,064  1......................................           5,064
610.40(g)(1); Documentation of medical                    3,470               1           3,470  0.5 (30 minutes).......................           1,735
 emergency.
630.15(a)(1)(ii)(B); Documentation required for           1,789               1           1,789  1......................................           1,789
 dedicated donation.
630.20(c); Documentation of exceptional medical           1,789               1           1,789  1......................................           1,789
 need.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................         495,247
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The recordkeeping requirements in Sec.  Sec.   606.171, 630.5(d), 630.10(c)(1) and (2), and 640.66, which address the maintenance of SOPs, are
  included in the estimate for Sec.   606.100(b).
\3\ The recordkeeping requirements in Sec.   640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in
  the estimate for Sec.   606.110(a).
\4\ The recordkeeping requirements in Sec.  Sec.   606.110(a)(2), 630.5(b)(1)(i), 630.10(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B),
  630.15(b)(2), (b)(7)(i) and (iii), 630.20(a) and (b), 640.21(e)(4), 640.25(b)(4) and (c)(1), 640.31(b), 640.33(b), 640.51(b), 640.53(b) and (c),
  640.56(b) and (d), 630.15(b)(2), 640.65(b)(2)(i), 640.65(b)(2)(i), 640.71(b)(1), 640.72, 640.73, and 640.76(a) and (b), which address the maintenance
  of various records are included in the estimate for Sec.   606.160.
\5\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
  3,470 = 422).
\6\ Five percent of plateletpheresis and leukapheresis establishments (0.05 x 856 = 43).

                                                Table 3--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
           21 CFR section; activity                Number of    disclosures per   Total annual       Average  burden per  disclosure        Total hours
                                                  respondents      respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.145(c); Notification of bacterial                    4,961           0.2822           1,400  0.02 (90 seconds)......................              28
 contamination of platelets.
606.170(a); Reports of transfusion reaction...         \2\ 422               12           5,064  0.5 (30 minutes).......................           2,532
610.40(c)(1)(ii); Labeling of donation                   3,470           0.0395             137  0.08 (5 minutes).......................              11
 dedicated to single recipient.
610.40(h)(2)(ii)(C) and (D); Labeling of                    15               12             180  0.2 (12 minutes).......................              36
 reactive blood and blood components.
610.40(h)(2)(vi); Labeling of reactive blood             3,470           2.1614           7,500  0.08 (5 minutes).......................             600
 and blood components.
610.42(a); Warning statement for medical                     1                1               1  1......................................               1
 devices.
610.46(a)(1)(ii)(B); Notification to                     1,789           5.1984           9,300  0.17 (10 minutes)......................           1,581
 consignees to quarantine (HIV ``lookback'').
610.46(a)(3); Notification to consignees of              1,789           5.1984           9,300  0.17 (10 minutes)......................           1,581
 further testing.
610.46(b)(3); Notification to recipients......           4,961           0.3528           1,750  1......................................           1,750
610.47(a)(1)(ii)(B); Notification to                     1,789          11.4030          20,400  0.17 (10 minutes)......................           3,468
 consignees to quarantine (HCV ``lookback'').
610.47(a)(3); Notification to consignees of              1,789          11.4030          20,400  0.17 (10 minutes)......................           3,468
 further testing.
610.47(b)(3); Notification to recipients......           4,961           0.4132           2,050  1......................................           2,050
630.40(a); Notification of donors determined               869          975.834         848,000  0.08 (5 minutes).......................          67,840
 not to be eligible for donation.
630.40(a); Notification of donors deferred                 133            6.323             841  1.5....................................           1,262
 based on reactive test results.
630.40(d)(1); Notification to physician of                  89            2.247             200  1......................................             200
 autologous donor.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ...............  ..............  .......................................          86,408
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
  3,470 = 422).

    The burden for this information collection has changed since the
last OMB approval. FDA estimates that the total burden for this
collection will be 583,473 hours (1,818 reporting + 495,247
recordkeeping + 86,408 third-party disclosure). Our estimated burden
for the information collection reflects an overall increase of 79,024
hours. We attribute this adjustment to an increase in the number of
blood establishments during the last 3 years.

    Dated: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03434 Filed 2-19-21; 8:45 am]
BILLING CODE 4164-01-P