using too much can lead to liver injury and death. Similarly, the use
of NSAIDs can lead to stomach bleeding and kidney damage. The number of
cases of injury reported is a very low percentage of the total use of
OTC acetaminophen and NSAID drug products. For many people, the risks
are quite low because they use these products only occasionally. The
risks may be greater for people who use these products more frequently
and/or do not follow the labeling information on the package. The risk
of injury may be increased for certain populations and under certain
conditions of use.
    There are multiple reasons for unintentional acetaminophen
overdoses. First, acetaminophen is an active ingredient in a wide
variety of both OTC and prescription drug products. For prescription
products, the immediate prescription container may not state that the
product contains acetaminophen or state the maximum daily dose limit.
Consumers may often fail to recognize the presence and amount of
acetaminophen ingredients in OTC and prescription drug products. This
lack of knowledge can result in a person using two different products
containing acetaminophen simultaneously. Moreover, many consumers are
unaware that exceeding the recommended dosage for acetaminophen can
lead to unintentional overdosing and cause potential harm. Based on the
evidence discussed in this document, we find that there is sufficient
incidence of liver injury associated with acetaminophen to warrant new
labeling, and that without the new labeling, acetaminophen products
would no longer be considered generally recognized as safe and
effective and not misbranded for OTC use.
    Results of several large-scale clinical studies performed in the
United States and in other countries have established that the use of
NSAIDs is an important risk factor for serious stomach adverse events,
especially bleeding. The risk is higher for certain populations. Based
on the evidence discussed in this document, we further find that NSAIDs
increase the risk for stomach adverse events and that, without a new
stomach bleeding warning in the labeling for NSAIDs, the products would
no longer be considered generally recognized as safe and effective and
not misbranded for OTC use.
    The purpose of this final rule is to amend our OTC drug labeling
regulations to include new warnings and other labeling requirements to
advise consumers of potential risks and when to consult a doctor (see
Table 1 in section I.B.2. of this document). We are also removing the
alcohol warning in Sec.  201.322 and incorporating new alcohol-related
warnings and other labeling for all OTC acetaminophen and NSAID drug
products. We are requiring certain warning information targeted to age-
specific populations. In addition, we are requiring that the presence
of acetaminophen or any NSAID would appear prominently on a product's
principal display panel (PDP).

B. Impact of the Rule

    We contracted Eastern Research Group, Inc. (ERG) to assess the
costs and benefits of the 2006 proposed rule on which this final rule
is based. The results of ERG's analysis apply to this final rule
because there are only minor differences between the proposed rule and
this final rule. We do not believe any of these differences will
significantly changes the costs and benefits determined by ERG. The
following is a summary of ERG's analysis; the full report, including
details on assumptions, cost calculations, and findings, is on file in
the Division of Dockets Management (Ref. 56).
    Manufacturers and marketers of OTC acetaminophen and NSAID drug
products would incur one-time costs to revise affected product labeling
to comply with this rule. We assumed an implementation period of 12
months for one-time costs for a major labeling revision. We estimated
one-time costs for a major labeling revision using a pharmaceutical
labeling revision cost model. This labeling model is described in
detail in Appendix A of the ERG report.
    To develop the original model, we and ERG interviewed
pharmaceutical representatives from regulatory, legal, manufacturing
controls, and labeling departments to collect information on labeling
change cost components, type of personnel affected, and costs. The
model incorporates data on average industry costs by company size,
including, where applicable, modifications to packaging configurations.
Industry consultants also provided information on model inputs related
to the OTC acetaminophen and NSAID drug product industry, the labeling
revision process, the costs of modifying labeling, and the frequency of
packaging reconfiguration changes.
    The baseline for this action is in full compliance with the format
and content requirements for OTC drug product labeling in 21 CFR
201.66. In the final rule that established these requirements on March
17, 1999 (64 FR 13254), we accounted for the total incremental costs to
comply with requirements, including 6 point font size and related costs
for increased package size and longer labeling where applicable. We
note that, although some forms of packaging (for small quantities) have
been granted extensions on compliance dates, many packaging
alternatives now exist to assure compliance.
    Manufacturers routinely change labels at varying intervals and have
standardized procedures in place for complying with our requirements.
The analysis assumes that one-half of the manufacturers of OTC
acetaminophen and NSAID drug products typically redesign their label
every 2 years, the remainder every 3 years, based on consultant input.
For this analysis, ERG assumed that manufacturers whose label redesign
cycle is less than the implementation period will not incur any
regulatory costs. For example, if a company routinely revises its
product labeling annually and is given at least that long to
incorporate the required changes, ERG judged that the regulatory
revision can be made at essentially no cost.
    The costs of labeling change depend on the type of labeling (e.g.,
carton and container label) and whether there is sufficient labeling
space to accommodate the proposed changes. There are an estimated
22,500 OTC acetaminophen and NSAID drug product stock keeping units
(SKUs), split evenly among branded and private labels, according to an
industry consultant.\10\ We assume branded SKUs are distributed as
follows by firm size: 50 percent small, 17 percent medium, and 33
percent large. Based on consultant input, we assumed the distribution
of SKUs among OTC acetaminophen and NSAID drug products as follows:
Acetaminophen, 45 percent; NSAIDs (except ibuprofen), 38 percent;
ibuprofen, 15 percent; and combinations of acetaminophen and NSAIDs, 2
percent. The ERG report presents model assumptions and methods for
calculating costs.
---------------------------------------------------------------------------

    \10\ Estimates of affected SKUs are 18,000 by FDA and 20,000 to
25,000 by industry consultant. This number of SKUs includes products
marketed by manufacturers, repackers, relabelers, and distributors.
---------------------------------------------------------------------------

    ERG visited five stores--two major chain drug stores and three
convenience stores--to collect information on the distribution of types
of OTC acetaminophen and NSAID drug product packaging. Roughly 80
percent of OTC acetaminophen and NSAID drug products were packaged in
cartons and 20 percent in containers. To assess the

increase in label space requirements, ERG purchased 45 affected
products, with an emphasis on smaller packages.
1. Label Area Changes
    ERG collected and recorded descriptive packaging information on the
sampled products and measured existing font size, labeling area and
labeling text on packages, and the area needed for replacement text.
ERG then calculated the percentage increase in square millimeters
needed to accommodate the proposed labeling changes. In all cases, ERG
determined that the requirement to add active ingredient names on the
PDP, while requiring major redesign in some cases, did not impose a
change in the size of the PDP or the addition of non-standard labeling
(such as adding a fifth carton panel or peel back label). ERG estimates
that the increase in existing label area needed to accommodate the
additional proposed label warnings and text ranges from 8 percent
(acetaminophen) to 32 percent (ibuprofen).
2. Package Size or Type Changes
    ERG measured the available panels and white space on the 45
packages sampled. If the available white space was greater than the
estimated increase in space necessary to accommodate the new label
warnings, ERG determined the product would not require an increase in
carton or container size. Based on this review, ERG assumed that all
current packaging can accommodate the required changes in this proposal
without altering label sizes, package sizes, or adding non-standard
labels. Therefore, ERG did not assign costs for adjustments to
packaging. Although finding only a few small foil packs that did not
comply with the OTC Drug Facts labeling requirements, ERG noted that
alternative types of packaging are now available to replace the older
packages.
    Table 2 presents the estimated total and annualized costs of
compliance with the OTC acetaminophen and NSAID drug product final
rule. The total estimated one-time costs to revise labeling are $32.6
million. The estimated annualized cost over the relevant relabeling
period is $15.2 million at a 7 percent discount rate. The estimated
average annualized cost per SKU is $677 (i.e., $15.2 million for 22,500
SKUs).

     Table 2--Estimated Total and Annualized Costs (at 7 Percent Discount Rate) of Compliance With This Rule
----------------------------------------------------------------------------------------------------------------
                                                        Dollars (in millions)
                    --------------------------------------------------------------------------------------------
                                                                                Combinations of
                       Company Type      Acetaminophen     NSAIDs except       Ibuprofen      Acetaminophen and
                                                             Ibuprofen                              NSAIDs
----------------------------------------------------------------------------------------------------------------
Total Costs
----------------------------------------------------------------------------------------------------------------
  Small Brand                     2.2               1.8               0.7              0.1                   4.9
----------------------------------------------------------------------------------------------------------------
  Medium Brand                    2.1               1.8               0.7              0.09                  4.7
----------------------------------------------------------------------------------------------------------------
  Large Brand                     6.0               5.1               2.0              0.3                  13.3
----------------------------------------------------------------------------------------------------------------
  Private Label                   4.4               3.7               1.5              0.2                   9.7
----------------------------------------------------------------------------------------------------------------
  Total                          14.7              12.4               4.9              0.7                  32.6
----------------------------------------------------------------------------------------------------------------
Total Annualized Costs
----------------------------------------------------------------------------------------------------------------
  Small Brand                     1                 0.9               0.3              0.05                  2.7
----------------------------------------------------------------------------------------------------------------
  Medium Brand                    1.0               0.8               0.3              0.04                  2.2
----------------------------------------------------------------------------------------------------------------
  Large Brand                     2.8               2.4               0.9              0.1                   6.2
----------------------------------------------------------------------------------------------------------------
  Private Label                   2.0               1.7               0.7              0.09                  4.5
----------------------------------------------------------------------------------------------------------------
  Total                           6.9               5.8               2.3              0.3                  15.2
----------------------------------------------------------------------------------------------------------------

C. Impact on Affected Sectors

    Manufacturers of OTC drug products are classified in North American
Industry Classification System (NAICS) 325412, pharmaceutical
preparation manufacturing. This classification code includes all
manufacturers of prescription and OTC pharmaceutical preparations, but
does not include relabelers, repackers, and distributors. The Small
Business Administration (SBA) defines a small business in this industry
classification code as one with fewer than 750 employees. In NAICS
325412, over 90 percent are considered small entities. The affected
industry is a subset of the OTC pharmaceutical industry. This final
rule affects an estimated 258 manufacturers of OTC acetaminophen and
NSAID drug products (200 of which are small businesses).
    Manufacturers often package private label products, although some
chains package their own brands. SBA considers the following to be
small: (1) Any pharmacy or drug store with annual sales under $6
million, and (2) supermarkets and other grocery stores and warehouses
and superstores with sales under $23 million. Generally, only the
largest supermarket and drug store chains (263 firms) or superstores (9
firms) would have their own private label. ERG included only those
largest retail chains with annual sales of $100 million or more as
having their own private labels. Thus, we believe that there are no
small entities in these retail sectors that are affected. Marketers of
private label OTC drug products are classified as follows:
     NAICS 446110: Pharmacies and drug stores
     NAICS 445110: Supermarkets and other grocery stores
     NAICS 452910: Warehouse clubs and superstores.
Packaging and labeling services that contract with pharmaceutical
manufacturing firms may also be

affected, but we assume manufacturers bear the costs of any labeling
changes. Both the manufacturing and marketing sectors will most likely
share costs, but the extent is not known. Therefore, this impact
analysis first assumes that manufacturers absorb all of the labeling
costs. We then assume that all private labeling costs are absorbed by
chain stores and calculate impacts.
    To assess the impact on entities in the pharmaceutical-
manufacturing sector (NAICS 325412), ERG adjusted SBA data on firm size
and revenues to estimate average receipts per firm for the affected
sector. ERG applied modeling assumptions to estimate the number of
large and small affected firms. ERG further assumed the distribution of
all 22,500 affected SKUs is one-third for large firms (producing either
branded or private label products) and two-thirds for small firms. To
estimate the share of total compliance costs for each size category,
ERG distributed the SKUs attributed to small businesses in the same
proportion as employment. The distribution of SKUs determines the
distribution of compliance costs by employment size category. Table 3
summarizes the estimated impacts for pharmaceutical manufacturers, the
total cost per firm based on $677 per SKU, and the compliance costs as
a percent of revenues.

       Table 3--Estimated Impacts on Pharmaceutical Preparation Manufacturing Firms by Size (NAICS 325412)
----------------------------------------------------------------------------------------------------------------
                          Average
 Firm Size (Number     Receipts per     Assumed  Number                     Total Firm Cost   Compliance Cost (%
   of Employees)     Firm (Dollars in       of SKUs        SKUs per Firm      (Dollars in        of Receipts)
                         Millions)                                           Thousands)\1\
----------------------------------------------------------------------------------------------------------------
<20                               1.7               841                 9               6.0              0.34%
----------------------------------------------------------------------------------------------------------------
20-99                            12.2             2,591                65              43.8              0.361%
----------------------------------------------------------------------------------------------------------------
100-499                          61.9             5,506               148             100.2              0.162%
----------------------------------------------------------------------------------------------------------------
500-749                         366.8             6,062               225             151.9              0.041%
----------------------------------------------------------------------------------------------------------------
Total small                      29.1            15,000                75              50.8              0.175%
----------------------------------------------------------------------------------------------------------------
>750                            947.8             7,500               130              88.1              0.009%
----------------------------------------------------------------------------------------------------------------
Total                           109.6            22,500                87              59.1              0.054%
----------------------------------------------------------------------------------------------------------------
\1\ Number of SKUs x $677 per SKU.
Source: SBA, 1999 and ERG estimates.

    Total estimated compliance costs per firm ranged from $6,000 for
firms with fewer than 20 employees to $152,000 for firms with 500 to
749 employees. The compliance cost as a percent of receipts is less
than 1 percent for all firms; 0.18 percent for all small firms and 0.01
for large firms. This estimate of impacts is somewhat understated
because the census data used to calculate estimates includes both OTC
and prescription drug manufacturers. However, no alternative revenue
and employment size information for affected product lines is
available. We conclude that this estimate of the impacts of this rule
does not constitute a significant economic impact on a substantial
number of small entities.
    In a similar analysis, we assume chain stores absorb costs for all
11,250 private label SKUs. Compliance costs as a percent of receipts
are less than 0.001 percent for all of the affected sectors:
Pharmacies, drug stores, superstores, supermarkets, and other grocery
stores. No small entities are affected.
    Manufacturers routinely change labels at varying intervals and have
standardized procedures in place for complying with our requirements.
This rule does not require any new reporting and record keeping
activities, and no additional professional skills are needed. There are
no other Federal rules that duplicate, overlap, or conflict with this
final rule; we are requiring removal of the existing alcohol warning in
Sec.  201.322.

D. Alternatives

    We do not believe that there are any alternatives to the final rule
that would adequately provide for the safe and effective use of OTC
acetaminophen and NSAID drug products. Nonetheless, we considered but
rejected the following alternatives: (1) Not adding the new information
to OTC acetaminophen and NSAID drug product labeling, and (2) a longer
implementation period. We do not consider either of these approaches
acceptable because they do not assure that consumers will have the most
current labeling information needed for the safe and effective use of
these products. We consider this final rule the least burdensome
alternative that meets the public health objectives of this rule.

E. Benefits

    Our final rule requirements are intended to enhance consumer
awareness and knowledge of the active ingredient in OTC acetaminophen
and NSAID drug products. These new warnings include:
     New label warnings
     Age-specific information
     Advising consumers of potential risks and when to consult
a doctor
     Prominent display of active ingredients on the PDP
The revised alcohol statements are intended to provide clearer warnings
to high-risk individuals about product use. The overall intent of these
requirements is to reduce the liver injury and stomach bleeding
episodes that occur due to unintentional overdosing with these drugs.
The requirements are also intended to reduce the incidence of adverse
health outcomes among high-risk subpopulations consuming proper doses
of OTC acetaminophen and NSAID drug products (e.g., people with liver
disease or prone to stomach bleeding).
    To estimate the benefits of this final rule, we developed baseline
information on the frequency of hospitalizations, emergency room
visits, and deaths related to unintentional overdosing with OTC
acetaminophen and NSAID drug products. We used a value of $5 million to
represent the premature loss of a statistical life in previous analyses
(66 FR 6137). We quantified the related hospital and emergency room
costs, estimated related morbidity costs, applied a value of $5 million
to the premature loss of a statistical life, and

estimated annual savings if 1 to 3 percent of these adverse events and
deaths are avoided (71 FR 77314 at 77341).
    We lack evidence to predict with certainty a specific level of
reduction in adverse events. Nonetheless, we believe that presenting
consumers with improved label warnings and more prominently displaying
the active ingredients on the PDP will promote safer use of OTC
acetaminophen and NSAID drug products. Specifically, prominent display
of the active ingredients on the PDP would alert consumers to the
presence of the active ingredients in OTC acetaminophen and NSAID drug
products and help minimize the risks of unintentional overdosing. The
revised warnings are intended to assist consumers, including higher
risk individuals, to use OTC acetaminophen and NSAID drug products more
safely and lead to at least a modest reduction in unintentional
overdosing.
    Table 4 summarizes the baseline and estimates of the number of
avoidable hospitalizations and emergency room visits, the average cost
per case, and potential savings from events avoided. These data do not
include reported cases of intentional overdosing. Based on the total
monetized costs per adverse health outcome and the number of cases
estimated to be avoided each year (from 1 to 3 percent), the total
monetized benefits of illness avoided range from $0.6 million to $1.8
million per year ($592,600 to $1,777,900).

 Table 4--Summary of Annual Monetized Benefits of Illnesses Avoided Associated With This Rule (in 2001 Dollars)
----------------------------------------------------------------------------------------------------------------
                                                                                Total Annual
                                                       Total                                         Monetized
                                    Willing to       Monetized      Potentially    Annual Number    Benefits of
 Adverse Health   Hospital Costs   Pay to Avoid      Value of       Preventable      of Cases         Illness
      Event                           Illness         Illness     Baseline Cases  Avoided Due to      Avoided
                                                      Avoided       per Year\1\    This Rule\2\     (Dollars in
                                                                                Thousands)
----------------------------------------------------------------------------------------------------------------
Minor drug                  $209            $301            $510           3,380          34-101     $17.2-$51.7
 toxicity or
 emergency room
 visits
----------------------------------------------------------------------------------------------------------------
Acetaminophen             $8,579          $2,000        $,10,579           3,424          34-103  $362.2-$1,086.
 poisoning                                                                                8
 episode with
 hospitalization
----------------------------------------------------------------------------------------------------------------
NSAID poisoning           $8,579            $357          $8,936           2,269           23-68   $202.8-$608.3
 episode with
 hospitalization
----------------------------------------------------------------------------------------------------------------
Acute kidney             $22,251   Not Estimated         $22,251               5       0.05-0.15       $1.1-$3.3
 failure with
 hospitalization
----------------------------------------------------------------------------------------------------------------
Acute kidney             $22,251   Not Estimated         $22,251             0.7     0.007-0.021       $0.2-$0.5
 failure with
 dialysis
----------------------------------------------------------------------------------------------------------------
Stomach bleeding         $14,653            $357         $15,010              61         0.6-1.8  ..............
----------------------------------------------------------------------------------------------------------------
Total monetized               NA              NA              NA              NA              NA  $592.6-$1,777.
 benefit of                                                                                9
 illness avoided
----------------------------------------------------------------------------------------------------------------
\1\ The number of potentially preventable baseline cases per year is derived from data on emergency department
  and hospital cases of overdosing, poisoning, or other serious adverse outcomes associated with acetaminophen
  and NSAID use, adjusted to estimate only unintentional cases.
\2\ Assumes this final rule would reduce annual adverse event cases by 1 to 3 percent (71 FR 77314 at 77344).

    In addition to estimating the value of preventing adverse drug
events that result in emergency department or hospitalization, we
considered the annual number of deaths related to unintentional
acetaminophen overdoses. We estimate that from 1996 to 1998, an annual
average of 100 adult deaths were related to unintentional acetaminophen
overdoses (71 FR 77314 at 77344). We assume this rule would reduce
deaths by 1 to 3 percent annually. Applying a value of $5 million for
each death prevented, we estimate the total benefits associated with
preventing 1 to 3 deaths to be $5 to $15 million annually (in 2001
dollars).
    If the required improved labeling and warnings reduced serious
adverse events by 1 to 3 percent each year, the total monetized value
of preventing illness and death would be $5.6 million to $16.8 million
per year, respectively. These benefits are presented in 2001 dollars.

Benefit Cost Comparison.

    Industry would incur the one-time costs of the final rule of $32.6
million in the first year. In 2001, the costs were $32.0 million.
However, the estimated savings from reduced hospital costs and deaths
avoided, from $5.6 to $16.8 million, would accrue each year. Over a 10-
year period, the $5.6 to $16.8 million per year in benefits has a
present value of $41.2 to $126.1 million at a discount rate of 7
percent, and a present value of $49.1 to $147.4 million at a discount
rate of 3 percent. Thus, the benefits of this final rule, assuming a 1
percent reduction in current levels of adverse health outcomes
associated with the use of OTC acetaminophen and NSAID drug products,
will more than offset the costs of this rule. Table 5 summarizes the
estimated benefits and costs of this final rule.

                       Table 5--Summary of Impacts
------------------------------------------------------------------------
                 Benefits/Costs                   Dollars (in Millions)
------------------------------------------------------------------------
Benefits:
 Monetized 1 and 3 percent reduction in  $6-$17
 illnesses and deaths per year
 Present value over 10 years at 7        $41-$126
 percent
 Present value over 10 years at 3        $49-$147
 percent
------------------------------------------------------------------------
Costs:

 One-time label revision, first year     $33
------------------------------------------------------------------------

Break-Even Analysis.

    We note that we lack the data needed to confidently predict a
percent reduction in serious cases related to unintentional overdosing.
Because of the uncertainty in these estimates, we estimated an annual
average number of adverse events that would need to be avoided over a
10-year period to reach a break-even point (i.e., the cost of
compliance/present value of avoiding one death each year for 10 years).
This final rule would need to prevent about 1 death each year over 10
years [0.9 deaths ($32/$37.6 million at a 7 percent discount rate) and
0.7 deaths ($32/$43.9 million at a 3 percent discount rate)].
Alternatively, if no deaths are avoided, the final rule would need to
prevent about 476 hospitalizations ($32 million/$67,000) each year over
the 10-year period. This estimate uses the present value of the lowest
benefit category of poisoning episode with hospitalizations, $8,936 per
episode over 10 years at a 7 percent discount rate. At a 3 percent
discount rate, an average of 407 hospitalizations ($32 million/$79,000)
would need to be avoided annually over the period.
    Although we lack evidence to predict with certainty a specific
level of reduction in adverse events, if we assume only a 1-percent
reduction in the illnesses and deaths analyzed, the benefits of this
final rule outweigh the costs. We find that this final rule will
enhance public health and promote the safer use of OTC acetaminophen
and NSAID drug products.
    This economic analysis, together with other relevant sections of
this document, serves as our final regulatory flexibility analysis, as
required under the Regulatory Flexibility Act. We did not receive any
submissions regarding the economic analysis in the 2006 PR.

VII. Paperwork Reduction Act of 1995

    We conclude that the labeling requirements in this document are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).

VIII. Environmental Impact

    We have determined under 21 CFR 25.31(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We provided the States with an
opportunity for appropriate participation in this rulemaking when we
sought input from all stakeholders through publication of the proposed
rule in the Federal Register of December 26, 2006 (71 FR 77314).
    On December 27, 2006, FDA's Division of Federal and State Relations
provided notice via email transmission of a letter to elected officials
of State governments and their representatives. The letter advised the
States of the publication of the proposed rule and stated that when
published as a final rule, this regulation would preempt State law in
accordance with section 751 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 379r(a)). The letter encouraged State and local
governments to review the proposed rule and to provide any comments to
the docket (Docket No. 1977N-0094L) by May 25, 2007, or to contact
certain named individuals. FDA did not receive any comments in response
to this notice, or any comments from the States in response to the
publication of the proposed rule.
    In conclusion, we believe that we have complied with all of the
applicable requirements under the Executive order and have determined
that the preemptive effects of this rule are consistent with Executive
Order 13132.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) under Docket No. 1977N-0094L and may be seen
by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Comment No. C7.
    2. Comment No. C3.
    3. Comment No. EMC1.
    4. Comment No. EREG4.
    5. Comment No. C6.
    6. Letter from Charles Ganley, FDA, to NSAID NDA Holders, July
2005.
    7. Comment No. EC1.
    8. Comment No. EC2.
    9. Comment No. EREG1.
    10. Comment No. C5.
    11. Comment No. EC4.
    12. Comment No. C8.
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and Warfarin in Patients: a Double-blind, Placebo-Controlled,
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Acetaminophen on the International Normalized Ratio in Patients
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    28. Gebauer, M. G. et al., ``Warfarin and Acetaminophen
Interaction,'' Pharmacotherapy, 23:109-12, 2003.
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Acetaminophen-Warfarin Interaction in an Older Adult: an Under-
Recognized Phenomenon?,'' Journal of American Medical Directors
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    30. Kotirum, S. et al., ``Utilization Review of Concomitant Use
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    31. Lehmann, D. E., ``Enzymatic Shunting: Resolving the
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2000.
    32. Thijssen, H. H. et al., ``Paracetamol (Acetaminophen)
Warfarin Interaction: NAPQI, the Toxic Metabolite of Paracetamol, Is
an Inhibitor of Enzymes in the Vitamin K Cycle,'' Thrombosis and
Haemostasis, 92:797-802, 2004.
    33. Toes, M. J., A. L. Jones, and L. Prescott, ``Drug
Interactions with Paracetamol,'' American Journal of Therapeutics,
12:56-66, 2005.
    34. Ansell, J. et al., ``Managing Oral Anticoagulant Therapy,''
Chest, 119:22S-38S, 2001.
    35. Moling, O. et al., ``Severe Hepatotoxicity After Therapeutic
Doses of Acetaminophen,'' Clinical Therapeutics, 28:755-60, 2006.
    36. Shriner, K. and M. B. Goetz, ``Severe Hepatotoxicity in a
Patient Receiving Both Acetaminophen and Zidovudine,'' American
Journal of Medicine, 93:94-6, 1992.
    37. Becker, K. et al., ``Glutathione and Association Antioxidant
Systems in Protein Energy Malnutrition: Results of a Study in
Nigeria,'' Free Radical Biology and Medicine, 18:257-263, 1995.
    38. Lauterburg, B. H., ``Analgesics and Glutathione,'' American
Journal of Therapeutics, 9:225-33, 2002.
    39. Zenger, F. et al., ``Decreased Glutathione in Patients with
Anorexia Nervosa. Risk Factor for Toxic Liver Injury?,'' European
Journal of Clinical Nutrition, 58:238-43, 2004.
    40. Schenker, S. et al., ``The Effects of Food Restriction in
Man on Hepatic Metabolism of Acetaminophen,'' Clinical Nutrition,
20:145-50, 2001.
    41. Whitcomb, D. C., D. Geoffery, and G. D. Block, ``Association
of Acetaminophen Hepatotoxicity with Fasting and Ethanol Use,''
Journal of the American Medical Association, 272:1845-1850, 1994.
    42. Kurtovic, J. and S. M. Riordan, ``Paracetamol-Induced
Hepatotoxicity at Recommended Dosage,'' Journal of Internal
Medicine, 253:240-243, 2003.
    43. Schmid, R., ``Gilbert's Syndrome--A Legitimate Genetic
Anomaly?,'' New England Journal of Medicine, 333:1117-8, 1995.
    44. Bosma, P. J. et al., ``The Genetic Basis of the Reduced
Expression of Bilirubin UDP-Glucuronosyltransferase 1 in Gilbert's
Syndrome,'' New England Journal of Medicine, 333:1171-5, 1995.
    45. Gelotte, C. K. et al., ``Disposition of Acetaminophen at 4,
6, and 8 g/day For 3 Days in Healthy Young Adults,'' Clinical
Pharmacology and Therapeutics, 81:840-8, 2007.
    46. de Morais, S. M., J. P. Uetrecht, and P. G. Wells,
``Decreased Glucuronidation and Increased Bioactivation of
Acetaminophen in Gilbert's Syndrome,'' Gastroenterology, 102:577-
586, 1992.
    47. Esteban, A. and M. P[eacute]rez-Mateo, ``Heterogeneity of
Paracetamol Metabolism in Gilbert's Syndrome,'' European Journal of
Drug Metabolism and Pharmacokinetics, 24:9-13, 1999.
    48. Ullrich, D. et al., ``Normal Pathways for Glucuronidation,
Sulphation and Oxidation of Paracetamol in Gilbert's Syndrome,''
European Journal of Clinical Investigation, 17:237-240, 1987.
    49. Comment No. C1.
    50. Cl[agrave]ria, J. et al., ``Effects of Celecoxib and
Naproxen on Renal Function in Nonazotemic Patients with Cirrhosis
and Ascites,'' Hepatology, 41:579-87, 2005.
    51. Arroyo, V. et al., ``Sympathetic Nervous Activity, Renin-
Angiotensin System and Renal Excretion of Prostaglandin E2 in
Cirrhosis. Relationship to Functional Renal Failure and Sodium and
Water Excretion,'' European Journal of Clinical Investigation,
13:271-8, 1983.
    52. ACP Medicine A Publican of the American College of
Physicians, WebMD, 2005.
    53. Goldfrank's Toxicologic Emergencies, 8th Ed., McGraw-Hill,
2006.
    54. Pharmacotherapeutics: A Primary Care Clinical Guide, 2nd
Ed., Pearson Prentice Hall, Upper Saddle River, NJ, 2005.
    55. Comment No. C4.
    56. Eastern Research Group, Inc. ``Cost Benefit Analysis of
Proposed FDA Rule on Over-the-Counter Internal Analgesic,
Antipyretic, and Antirheumatic Drug Products; Required Warnings,''
Final Report, October 6, 2004, with Addendum, July 30, 2007.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
201 is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Section 201.66 is amended by revising paragraph (c)(5)(ii)(E) to
read as follows:

Sec.  201.66   Format and content requirements for over-the-counter
(OTC) drug product labeling.

* * * * *
    (c) * * *
    (5) * * *
    (ii) * * *
    (E) Liver warning set forth in Sec.  201.326(a)(1)(iii) and/or
stomach bleeding warning set forth in Sec.  201.326(a)(2)(iii). The
liver warning shall follow the subheading ``Liver warning:'' and the
stomach bleeding warning shall follow the subheading ``Stomach bleeding
warning:''
* * * * *

Sec.  201.322   [Removed]

0
3. Remove Sec.  201.322.

0
4. Section 201.326 is added to subpart G to read as follows:

Sec.  201.326   Over-the-counter drug products containing internal
analgesic/antipyretic active ingredients; required warnings and other
labeling.

    (a) Labeling. The labeling for all over-the-counter (OTC) drug
products containing any internal analgesic/antipyretic active
ingredients (including, but not limited to, acetaminophen, aspirin,
carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen,
magnesium salicylate, naproxen sodium, and sodium salicylate) alone or
in combination must bear the following labeling in accordance with
Sec. Sec.  201.60, 201.61, and 201.66.
    (1) Acetaminophen.
    (i) Statement of identity. The statement of identity appears in
accord with Sec. Sec.  201.61 and 299.4 of this chapter. The ingredient
name ``acetaminophen'' must appear highlighted (e.g., fluorescent or
color contrast) or in bold type, be in lines generally parallel to the
base on which the package rests as it is designed to be displayed, and
be in one of the following sizes, whichever is greater:
    (A) At least one-quarter as large as the size of the most prominent
printed matter on the principal display panel (PDP), or
    (B) At least as large as the size of the ``Drug Facts'' title, as
required in Sec.  201.66(d)(2). The presence of acetaminophen must
appear as part of the established name of the drug, as defined in Sec.
299.4 of this chapter. Combination products containing acetaminophen
and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the
name ``acetaminophen'' and the name(s) of the other active
ingredient(s) in the product on the PDP in accord with this paragraph.
Only the name ``acetaminophen'' must appear highlighted or in bold
type, and in a prominent print size, as described in this paragraph.
    (ii) Active Ingredient and Purpose Headings. The information
required under Sec.  201.66(c)(2) and (c)(3) of this chapter must be
included under these

headings. The information under these headings, but not the headings,
may appear highlighted.
    (iii) For products labeled for adults only. The labeling of the
product states the following warnings under the heading ``Warnings'':
    (A) ``Liver warning [heading in bold type]: This product contains
acetaminophen. Severe liver damage may occur if you take [bullet] more
than [insert maximum number of daily dosage units] in 24 hours, which
is the maximum daily amount [bullet] with other drugs containing
acetaminophen [bullet] 3 or more alcoholic drinks every day while using
this product''. This ``Liver warning'' must be the first warning under
the ``Warnings'' heading. For products that contain both acetaminophen
and aspirin, this ``Liver warning'' must appear after the ``Reye's
syndrome'' and ``Allergy alert'' warnings in Sec.  201.66(c)(5)(ii)(A)
and (c)(5)(ii)(B) and before the ``Stomach bleeding warning'' in
paragraph (a)(2)(iii)(A) of this section. If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers.
    (B) ``Do not use with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.''
    (C) ``Ask a doctor before use if you have liver disease''.
    (D) ``Ask a doctor or pharmacist before use if you are taking the
blood thinning drug warfarin'' except on the labeling of combination
products that contain acetaminophen and NSAID(s).
    (iv) For products labeled only for children under 12 years of age.
    (A) Warnings. The labeling of the product states the following
warnings under the heading ``Warnings'':
    (1) ``Liver warning [heading in bold type]: This product contains
acetaminophen. Severe liver damage may occur if your child takes
[bullet] more than 5 doses in 24 hours, which is the maximum daily
amount [bullet] with other drugs containing acetaminophen''. This
``Liver warning'' must be the first warning under the ``Warnings''
heading. If there is an outer and immediate container of a retail
package, this warning must appear on both the outer and immediate
containers.
    (2) ``Do not use with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.''
    (3) ``Ask a doctor before use if your child has liver disease''.
    (4) ``Ask a doctor or pharmacist before use if your child is taking
the blood thinning drug warfarin'' except on the labeling of
combination products that contain acetaminophen and NSAID(s).
    (B) Directions. The labeling of the product contains the following
information under the heading ``Directions'': ``this product does not
contain directions or complete warnings for adult use'' [in bold type].
    (v) For products labeled for adults and children under 12 years of
age. The labeling of the product states all of the warnings in
paragraphs (a)(1)(iii)(A), (a)(1)(iii)(B), and (a)(1)(iii)(C) of this
section with the following modifications:
    (A) The liver warning states ``Liver warning [heading in bold
type]: This product contains acetaminophen. Severe liver damage may
occur if [bullet] adult takes more than [insert maximum number of daily
dosage units] in 24 hours, which is the maximum daily amount [bullet]
child takes more than 5 doses in 24 hours [bullet] taken with other
drugs containing acetaminophen [bullet] adult has 3 or more alcoholic
drinks everyday while using this product.'' If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers.
    (B) ``Ask a doctor before use if the user has liver disease.''
    (C) ``Do not use with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.''
    (D) ``Ask a doctor or pharmacist before use if the user is taking
the blood thinning drug warfarin'' except on the labeling of
combination products that contain acetaminophen and NSAID(s).
    (2) Nonsteroidal anti-inflammatory analgesic/antipyretic active
ingredients--including, but not limited to, aspirin, carbaspirin
calcium, choline salicylate, ibuprofen, ketoprofen, magnesium
salicylate, naproxen sodium, and sodium salicylate.
    (i) Statement of identity. The statement of identity appears in
accord with Sec. Sec.  201.61 and 299.4 of this chapter. The word
``(NSAID)'' must appear highlighted (e.g., fluorescent or color
contrast) or in bold type, be in lines generally parallel to the base
on which the package rests as it is designed to be displayed, and be in
one of the following sizes, whichever is greater:
    (A) At least one-quarter as large as the size of the most prominent
printed matter on the PDP, or
    (B) At least as large as the size of the ``Drug Facts'' title, as
required in Sec.  201.66(d)(2). The word ``(NSAID)'' must appear as
part of the established name of the drug, as defined in Sec.  299.4 of
this chapter, or after the general pharmacological (principal intended)
action of the NSAID ingredient. Combination products containing an
NSAID and a nonanalgesic ingredient(s) (e.g., cough-cold) must include
the name of the NSAID ingredient and the word ``(NSAID)'' in accordance
with this paragraph, and the name(s) of the other active ingredient(s)
in the product on the PDP. Only the word ``(NSAID)'' needs to appear
highlighted or in bold type, and in a prominent print size, as
described in this paragraph.
    (ii) Active Ingredient and Purpose Headings. The information
required under Sec.  201.66(c)(2) and (c)(3) of this chapter must be
included under these headings. The active ingredient(s) section of the
product's labeling, as defined in Sec.  201.66(c)(2), contains the term
``(NSAID*)'' after the NSAID active ingredient with an asterisk
statement at the end of the active ingredient(s) section that defines
the term ``NSAID'' and states ``* nonsteroidal anti-inflammatory
drug.'' The information under these headings may appear highlighted.
However, the headings ``Active Ingredient'' and ``Purpose'' may not
appear highlighted.
    (iii) For products labeled for adults only. The labeling of the
product states the following warnings under the heading ``Warnings'':
    (A) ``Stomach bleeding warning [heading in bold type]: This product
contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause
severe stomach bleeding. The chance is higher if you [bullet] are age
60 or older [bullet] have had stomach ulcers or bleeding problems
[bullet] take a blood thinning (anticoagulant) or steroid drug [bullet]
take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others) [bullet] have 3 or more
alcoholic drinks every day while using this product [bullet] take more
or for a longer time than directed''. This ``Stomach bleeding warning''
must appear after the ``Reye's syndrome'' and ``Allergy alert''
warnings in Sec.  201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). For products
that contain both acetaminophen and aspirin, the acetaminophen ``Liver
warning'' in paragraph (a)(1)(iii) of this section must appear before
the ``Stomach bleeding warning'' in this paragraph. If there is

an outer and immediate container of a retail package, this warning must
appear on both the outer and immediate containers.
    (B) ``Ask a doctor before use if [bullet] stomach bleeding warning
applies to you [bullet] you have a history of stomach problems, such as
heartburn [bullet] you have high blood pressure, heart disease, liver
cirrhosis, or kidney disease [bullet] you are taking a diuretic''.
    (C) ``Stop use and ask a doctor if [bullet] you experience any of
the following signs of stomach bleeding:'' [add the following as second
level of statements: ``[bullet] feel faint [bullet] vomit blood
[bullet] have bloody or black stools [bullet] have stomach pain that
does not get better''].
    (iv) For products labeled only for children under 12 years of age.
    (A) Warnings. The labeling of the product states the following
warnings under the heading ``Warnings'':
    (1) ``Stomach bleeding warning [heading in bold type]: This product
contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause
severe stomach bleeding. The chance is higher if your child [bullet]
has had stomach ulcers or bleeding problems [bullet] takes a blood
thinning (anticoagulant) or steroid drug [bullet] takes other drugs
containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,
naproxen, or others) [bullet] takes more or for a longer time than
directed''. The ``Stomach bleeding warning'' must appear after the
``Reye's syndrome'' and ``Allergy alert'' warnings in Sec.
201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers.
    (2) ``Ask a doctor before use if [bullet] stomach bleeding warning
applies to your child [bullet] child has a history of stomach problems,
such as heartburn [bullet] child has not been drinking fluids [bullet]
child has lost a lot of fluid due to vomiting or diarrhea [bullet]
child has high blood pressure, heart disease, liver cirrhosis, or
kidney disease [bullet] child is taking a diuretic''.
    (3) ``Stop use and ask a doctor if [bullet] child experiences any
of the following signs of stomach bleeding:'' [add the following as
second level of statements: [bullet] feels faint [bullet] vomits blood
[bullet] has bloody or black stools [bullet] has stomach pain that does
not get better''].
    (B) Directions. The labeling of the product contains the following
information under the heading ``Directions'': ``this product does not
contain directions or complete warnings for adult use'' [in bold type].
    (v) For products labeled for adults and children under 12 years of
age. The labeling of the product states all of the warnings in
paragraphs (a)(2)(iii)(A) through (a)(2)(iii)(C) of this section with
the following modifications:
    (A) The Stomach bleeding warning states ``Stomach bleeding warning
[heading in bold type]: This product contains a nonsteroidal anti-
inflammatory drug (NSAID), which may cause severe stomach bleeding. The
chance is higher if the user [bullet] has had stomach ulcers or
bleeding problems [bullet] takes a blood thinning (anticoagulant) or
steroid drug [bullet] takes other drugs containing prescription or
nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
[bullet] takes more or for a longer time than directed [bullet] is age
60 or older [bullet] has 3 or more alcoholic drinks everyday while
using this product''. The ``Stomach bleeding warning'' must appear
after the ``Reye's syndrome'' and ``Allergy alert'' warnings in Sec.
201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and
immediate container of a retail package, this warning must appear on
both the outer and immediate containers.
    (B) The labeling states ``Ask a doctor before use if [bullet]
stomach bleeding warning applies to user [bullet] user has history of
stomach problems, such as heartburn [bullet] user has high blood
pressure, heart disease, liver cirrhosis, or kidney disease [bullet]
user takes a diuretic [bullet] user has not been drinking fluids
[bullet] user has lost a lot of fluid due to vomiting or diarrhea''.
    (C) The labeling states ``Stop use and ask a doctor if [bullet]
user experiences any of the following signs of stomach bleeding:'' [add
the following as second level of statements: [bullet] feels faint
[bullet] vomits blood [bullet] has bloody or black stools [bullet] has
stomach pain that does not get better''].
    (b) New warnings information statement. The labeling of any drug
product subject to this section that is initially introduced or
initially delivered for introduction into interstate commerce before
the effective date and within 12 months after the effective date of the
final rule must bear on its PDP, as defined in Sec.  201.60, the
statement ``See new warnings information.'' This statement must appear
highlighted (e.g., fluorescent or color contrast) or in bold type, be
in lines generally parallel to the base on which the package rests as
it is designed to be displayed, and be in one of the following sizes,
whichever is greater: (1) At least one-quarter as large as the size of
the most prominent printed matter on the PDP, or (2) At least as large
as the size of the ``Drug Facts'' title, as required in Sec.
201.66(d)(2).
    (c) Requirements to supplement approved application. Holders of
approved applications for OTC drug products that contain internal
analgesic/antipyretic active ingredients that are subject to the
requirements of paragraph (a) of this section must submit supplements
under Sec.  314.70(c) of this chapter to include the required
information in the product's labeling. Such labeling may be put into
use without advance approval of FDA provided it includes at least the
exact information included in paragraph (a) of this section.

    Dated: April 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9684 Filed 4-28-09; 8:45 am]

BILLING CODE 4160-01-S


Interagency Review
   1.)    Submission to OMB on August 31, 2011
   2.)    Interagency Comments 1  -  email from Nathan Frey, OMB/OIRA, to Jeremy Arling, EPA, on September 27, 2011
   3.)    EPA Response to Interagency Comments 1  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on October 11, 2011
   4.)    EPA Response to Interagency Comments 2  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on October 27, 2011
   5.)    EPA Response to Interagency Comments 3  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on November 7, 2011
   6.)    Interagency Comments 2  -  email from Nathan Frey, OMB/OIRA, to Luke Hall-Jordan, EPA, on November 7, 2011
   7.)    EPA Response to Interagency Comments 4  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on November 17, 2011
   8.)    Interagency Request to see EPA memos  -  email from Nathan Frey, OMB/OIRA, to Luke Hall-Jordan, EPA, on November 29, 2011
   9.)    EPA Response to Interagency Request  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on November 29, 2011
   10.)    EPA Response to Interagency Comments 5  -  email from Luke Hall-Jordan, EPA, to Nathan Frey, OMB/OIRA, on December 13, 2011
   11.)    OMB Concurrence  -  email from Nathan Frey, OMB/OIRA, to Luke Hall-Jordan, EPA, on December 14, 2011
   12.)    Final Proposed Rule Showing Changes


[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Notices]
[Page 56428]
[FR Doc No: 2011-23314]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX11-1-000]

Southern Cross Transmission LLC; Pattern Power Marketing LLC;
Notice of Filing

    Take notice that on September 6, 2011, pursuant to sections 210,
211, and 212 of the Federal Power Act and Part 36 of the Federal Energy
Regulatory Commission's (Commission) Regulations, 18 CFR 36.1, Southern
Cross Transmission, LLC (SCT) and Pattern Power Marketing LLC (PPM)
jointly filed an application requesting that the Commission direct (1)
the City of Garland, Texas and Garland Power & Light to provide an
interconnection at a point at the Texas-Louisiana border; and (2) Oncor
Electric Delivery Company LLC (Oncor) and CenterPoint Energy Houston
Electric, LLC to provide the requested transmission service to PPM or
any other entity that is an eligible customer under Oncor's Tariff for
Transmission Service To, From, and Over Certain Inconnections.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 6, 2011.

    Dated: September 7, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-23314 Filed 9-12-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14272-14275]
[FR Doc No: 2020-04946]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, Washington, DC 20549-2736.

Extension:
    Rules 15Ba1-1 through 15Ba1-8, SEC File No. 270-619, OMB Control
No. 3235-0681.

    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 provided for in Rules 15Ba1-1 to 15Ba1-8 (17 CFR 240.15Ba1-
1 to 17 CFR 240.15Ba1-8)--Registration of Municipal Advisors, under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (the ``Act'').
The Commission plans to submit this existing collection of information
to the Office of Management and Budget for extension and approval.
    On September 20, 2013 (see 78 FR 67468, November 12, 2013), the
Commission adopted Rules 15Ba1-1 through 15Ba1-8 and Rule 15Bc4-1 under
the Act to establish the rules by which a municipal advisor must
obtain, maintain, and terminate its registration with the Commission.
In addition, the rules interpret the definition of the term ``municipal
advisor,'' interpret the statutory exclusions from that definition, and
provide certain additional regulatory exemptions. The rules became
effective on January 13, 2014; however, on January 13, 2014, the
Commission temporarily stayed such rules until July 1, 2014 (see 79 FR
2777, January 16, 2014). Amendments to Form MA and Form MA-I designed
to eliminate aspects of the forms that request filers to provide
certain forms of

personally identifiable information (``PII''), including Social
Security numbers, dates of birth, or Foreign ID numbers became
effective on May 14, 2018 (see 83 FR 22190, May 14, 2018). Section
15B(a)(1) of the Act makes it unlawful for a municipal advisor to
provide advice to or on behalf of a municipal entity or obligated
person with respect to municipal financial products or the issuance of
municipal securities, or to undertake certain solicitations of a
municipal entity or obligated person, unless the municipal advisor is
registered with the Commission. The rules, among other things (i)
require municipal advisors to file certain forms (i.e., Form MA, Form
MA-A, Form MA/A, Form MA-I, Form MA-I/A, Form MA-NR, and Form MA-W)
with the Commission to obtain, maintain, or terminate their
registration with the Commission and maintain certain books and records
in accordance with the Act, and (ii) set forth how certain entities may
meet the requirements of the statutory exclusions or regulatory
exemptions from the definition of ``municipal advisor.''

Form MA

    The Commission estimates that approximately 35 respondents will
submit new Form MA applications annually in each of the next three
years.\1\ The Commission further estimates that each submission will
take approximately 3.5 hours. Thus, the total annual burden borne by
respondents for submitting an initial Form MA application will be
approximately 123 hours.\2\ The Commission estimates that respondents
submitting new Form MA applications would, on average, consult with
outside counsel for one hour, at a rate of $400/hour. Thus, the
Commission estimates that the average total annual cost that may be
incurred by all respondents filing new Form MA applications will be
$14,000.\3\ In addition to filing initial Form MA applications, the
rules require municipal advisors to amend Form MA once annually (Form
MA-A) and after the occurrence of any enumerated material event (Form
MA/A). The requirement to amend Form MA applies to all registered
municipal advisors. There are currently approximately 535 municipal
advisors registered with the Commission and, as noted above, the
Commission anticipates receiving 105 new Form MA submissions over the
next three years. Therefore, the Commission expects that the rules'
requirement to amend Form MA will apply to approximately 570 municipal
advisors in year one, approximately 605 municipal advisors in year two,
and approximately 640 municipal advisors in year three. The Commission
estimates that completing an annual amendment would take a municipal
advisor approximately 1.5 hours and completing a material event
amendment would take 0.5 hours. The Commission further estimates that
each municipal advisor will submit two amendments per year (one Form
MA-A and one Form MA/A). Thus, the Commission estimates that the
average annual burden borne by respondents for amending Form MA during
the three-year period will be approximately 1,210 hours.\4\
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    \1\ The estimate is derived by averaging the number of Form MA
filings over the last three years and rounding up. There were 39
Form MA submissions in 2017, 34 Form MA submissions in 2018, and 30
Form MA submissions in 2019.
    \2\ 35 respondents x 3.5 hours = 122.5 hours.
    \3\ 35 respondents x ($400/hour x 1 hour) = $14,000.
    \4\ ((570 respondents x 2 hours) + (605 respondents x 2 hours) +
(640 respondents x 2 hours))/3 = 1,210 hours.
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Form MA-I

    The Commission estimates that it will receive approximately 570 new
Form MA-I submissions annually.\5\ The Commission further estimates
that each Form MA-I submission will take approximately three hours to
complete. Thus, the total annual burden borne by respondents submitting
Form MA-I will be approximately 1,710 hours.\6\ The Commission also
estimates that a Form MA-I respondent will submit 2.95 updating
amendments per year (Form MA-I/A), and that each such amendment will
take approximately 0.5 hours to complete.\7\ There are currently
approximately 3,385 Form MA-Is on file with the Commission for natural
persons currently associated with a municipal advisor and, as noted
above, the Commission expects to receive 1,710 Form MA-I submissions
over the next three years.\8\ Therefore, the Commission expects the
rules' requirement to amend Form MA-I to apply to approximately 3,955
Form MA-Is in year one, approximately 4,525 Form MA-Is in year two, and
approximately 5,095 Form MA-Is in year three. Thus, the Commission
estimates that the average annual burden borne by respondents
submitting Form MA-I amendments during the three-year period will be
approximately 6,674 hours.\9\
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    \5\ The estimate is derived by averaging the number of Form MA-I
submissions over the last three years. There were 619 Form MA-I
submissions in 2017, 466 Form MA-I submissions in 2018, and 624 Form
MA-I submissions in 2019.
    \6\ 570 submissions x 3 hours = 1,710 hours.
    \7\ The estimate is derived by averaging the number of updating
amendments submitted by respondents over the last three years. In
2017, the average number is 2,078 Form MA-I/A/574 municipal advisors
= 3.62. In 2018 the average number is 1,398 Form MA-I/A/555
municipal advisors = 2.52. In 2019, the average number is 1,442 Form
MA-I/A/535 municipal advisors = 2.70. Averaging the average number
of updating amendments for the last three years: 3.62 (2017) + 2.52
(2018) + 2.70 (2019)/3 = 2.95 updating amendments per year.
    \8\ The estimated number of active Form MA-I filings is derived
by taking the total number of Form MA-I submissions with the
Commission as of December 31, 2019 and subtracting the number of
Form MA-I/A withdrawals as of the same date. 7,564 (Form MA-I
submissions) - 4,179 (Form MA-I/A withdrawals) = 3,385 Form MA-Is on
file.
    \9\ (((3,955 Form MA-I/As x (2.95 amendments x 0.5 hours)) +
((4,525 Form MA-I/As x (2.95 amendments x 0.5 hours)) + ((5,095 Form
MA-I/As x (2.95 amendments x 0.5 hours)))/3 = 6,674.375 hours.
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Form MA-W

    The Commission estimates that it will receive 46 new Form MA-W
submissions annually.\10\ The Commission further estimates that each
Form MA-W submission will take approximately 0.5 hours to complete.
Thus, the total annual burden borne by respondents submitting Form MA-W
will be approximately 23 hours.\11\
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    \10\ The estimate of 46 Form MA-W submissions is derived by
averaging the number of Form MA-W submissions over the last two
years. There were 46 Form MA-W submissions in 2018 and 2019
respectively. The filing number from 2017 was omitted because an
abnormally large number of Form MA-W submissions were submitted (116
submissions in 2017), likely due to the advent of the Municipal
Securities Rulemaking Board's Series 50 exam requirement which
became effective on September 12, 2017.
    \11\ 46 respondents x 0.5 hours = 23 hours.
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Form MA-NR

    The Commission estimates that three municipal advisors will have a
non-resident general partner, non-resident managing agent, or non-
resident associated person and such advisors will submit a total of
approximately five Form MA-NRs annually.\12\ The Commission further
estimates that each Form MA-NR submission will take approximately 1.5
hours to complete. Thus, the total annual burden borne by respondents
submitting Form MA-NR will be approximately 7.5 hours.\13\ In addition,
each respondent that submits a Form MA-NR must also provide an opinion
of counsel. The Commission estimates that such an opinion of counsel
would take three hours to complete, at a rate of $400/hour. Thus, the
Commission estimates that the total annual burden borne by respondents
providing an opinion of counsel will be

approximately nine hours.\14\ The estimated average total cost that may
be incurred by all respondents providing an opinion of counsel will be
$3,600.\15\
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    \12\ The estimate is derived by averaging the number of Form MA-
NR submissions over the last three years. There were seven Form MA-
NR submissions in 2017, four Form MA-NR submissions in 2018, and
five Form MA-NR submissions in 2019.
    \13\ 3 respondents x (1.67 Form MA-NR submissions x 1.5 hours) =
7.5 hours.
    \14\ 3 respondents x 3 hours = 9 hours.
    \15\ 3 respondents x (3.0 hours x $400/hour) = $3,600.
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Consent to Service of Process

    The Commission estimates that 35 new municipal advisors will have
to develop a template document to use in obtaining written consents to
service of process from their associated persons annually. The
Commission further estimates that each template document will take
approximately one hour to draft. Thus, the Commission estimates that
the total annual burden borne by respondents developing a template
document will be approximately 35 hours.\16\ In addition, the
Commission estimates that municipal advisors will need to obtain 570
new consents to service of process from associated persons annually.
The Commission further estimates that, after the written consents are
drafted, it will take municipal advisors approximately 0.10 hours to
obtain each consent. Thus, the Commission estimates that the total
annual burden borne by respondents obtaining consents to service of
process will be 92 hours.\17\
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    \16\ 35 respondents x 1 hour = 35 hours.
    \17\ 35 hours + (570 x 0.1 hours) = 92 hours.
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Books and Records To Be Maintained by Municipal Advisors

    The Commission estimates 570, 605, and 640 municipal advisors will
be subject to the books and records rules during each of the next three
years, respectively. The Commission further estimates that the average
annual burden for a municipal advisor to comply with the books and
records requirement is approximately 182 hours. Thus, the Commission
estimates that the average annual burden borne by respondents to comply
with the books and records requirements during the three-year period
will be approximately 110,110 hours.\18\
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    \18\ ((570 respondents x 182 hours) + (605 respondents x 182
hours) + (640 respondents x 182 hours))/3 = 110,110 hours.
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Independent Registered Municipal Advisor Exemption

    The Commission estimates that approximately 231 persons will seek
to rely on the independent registered municipal advisor exemption
annually.\19\ The Commission further estimates that the one-time burden
of developing a written template disclosure document will be
approximately one hour. Thus, the Commission estimates that the total
one-time burden borne by respondents developing a template disclosure
document will be approximately 231 hours.\20\ The Commission also
recognizes that respondents will be subject to a recurring burden each
time they seek to rely on the exemption. The Commission estimates that
respondents may seek the exemption on approximately 8,211 transactions
annually.\21\ The Commission further estimates that the burden of
obtaining the written representations needed from the municipal entity
or obligated person client will be approximately 0.25 hours. Thus, the
Commission estimates that the total annual burden borne by respondents
seeking to rely on the independent registered municipal advisor
exemption will be approximately 2,053 hours.\22\
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    \19\ Estimate based on information obtained from Mergent
Municipal Bond Securities Database. The estimate represents the
average number of underwriters that participated in negotiated
transactions from 2017 to 2019.
    \20\ 231 respondents x 1 hour = 231 hours.
    \21\ Estimate based on information obtained from Mergent
Municipal Bond Securities Database. The estimate represents the
average number of negotiated deals using an underwriter each year.
    \22\ 8,211 transactions x 0.25 hours = 2,052.75 hours.
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Municipal Escrow Investments

    The Commission estimates that approximately 694 respondents will
seek to rely on the municipal escrow investments exemption.\23\ The
Commission further estimates that the one-time burden of creating a
template document to use in obtaining the written representations
necessary to rely on the exemption will be approximately one hour.
Thus, the Commission estimates that the total one-time burden borne by
respondents developing a template document will be approximately 694
hours.\24\ The Commission also recognizes that respondents will be
subject to a recurring burden each time they seek to rely on the
exemption. The Commission estimates the respondents will seek to rely
on the exemption with approximately 2,321 municipal entity clients.\25\
The Commission further estimates that the burden of obtaining the
required written representations from the respondent's client will be
approximately 0.25 hours. Thus, the Commission estimates that the total
annual burden borne by respondents seeking to rely on the municipal
escrow investments exemption will be approximately 580 hours.\26\
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    \23\ The Commission estimates in this section are based on
information reported directly by state-registered investment
advisers in Item 5.D.(i)(1) within Form ADV.
    \24\ 694 respondents x 1 hour = 694 hours.
    \25\ The Commission estimates in this section are based on
information reported directly by state-registered investment
advisers in Item 5.D.(i)(1) within Form ADV.
    \26\ 2,321 clients x 0.25 hours = 580.25 hours.
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Proceeds of Municipal Securities

    The Commission estimates that approximately 720 respondents will
seek to rely on the proceeds of municipal securities exemption.\27\ The
Commission further estimates that the one-time burden of creating a
template document to use in obtaining the written representations
necessary to rely on the exemption will be approximately one hour.
Thus, the Commission estimates that the total one-time burden borne by
respondents developing a template document will be approximately 720
hours.\28\ The Commission also recognizes that respondents will be
subject to a recurring burden each time they seek to rely on the
exemption. The Commission estimates that respondents will seek to rely
on the exemption in connection with services provided to approximately
4,056 clients.\29\ The Commission further estimates that the burden of
obtaining the required written consents from the respondent's client
will be approximately 0.25 hours. Thus, the Commission estimates that
the total annual burden borne by respondents seeking to rely on
proceeds of municipal securities exemption will be approximately 1,014
hours.\30\
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    \27\ The Commission estimates in this section are based on
information reported directly by state-registered investment
advisers in Item 5.D.(f)(1) within Form ADV. The number of state-
registered investment advisers which have pooled investment vehicle
clients (other than investment company and business development
company clients) within Form ADV, Item 5.D.(f)(1) = 637. The
percentage of state-registered investment advisers which have
municipal government entity clients (other than investment company
and business development company clients) within Form ADV, Item
5.D.(f)(1) = 4%. (637 x .04) = 26. The number of state-registered
investment advisers relying on the exception to the definition of
``municipal escrow investment'' = 694. (26 + 694) = 720 respondents.
    \28\ 720 respondents x 1 hour = 720 hours.
    \29\ The number of municipal entity clients of state-registered
investment advisers relying on the exception to the definition of
``municipal escrow investment'' in Item 5.D.(i)(1) within Form ADV =
2,321 clients. The number of pooled investment vehicle clients
(other than investment company and business development company
clients) of state-registered investment advisers in Item 5.D.(f)(1)
within Form ADV = 1,735 clients. (2,321 + 1,735) = 4,056 clients.
    \30\ 4,056 clients x 0.25 hours = 1,014 hours.
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    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility;

(b) the accuracy of the Commission's estimates 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.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number. Please direct your
written comments to: David Bottom, Director/Chief Information Officer,
Securities and Exchange Commission, c/o Cynthia Roscoe, 100 F Street
NE, Washington, DC 20549 or send an email to<EMAIL_ADDRESS>
    Dated: March 6, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-04946 Filed 3-10-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 31, 2006 (Volume 71, Number 62)]
[Notices]
[Page 16350]
[DOCID:fr31mr06-102]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act; Notice of Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meeting during the week
of April 3, 2006:
    A Closed Meeting will be held on Thursday, April 6, 2006 at 10 a.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10) permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Atkins, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
April 6, 2006 will be: Institution and settlement of injunctive
actions; Institution and settlement of administrative proceedings of an
enforcement nature; Opinion; and Formal orders of investigation.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: March 29, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. 06-3183 Filed 3-29-06; 3:46 pm]

BILLING CODE 8010-01-P