SUPPORTING STATEMENT

Food Labeling Regulations

(21 CFR Parts 101, 102, 104, and 105)

0910-0381

**A. JUSTIFICATION**

**1. Necessity of the Information Collection**

Section 403 (21 U.S.C. 343) of the Federal Food, Drug, and Cosmetic Act
(the act) establishes requirements that the label or labeling of a food
product must meet so that it is not misbranded and subject to regulatory
action. Certain of the provisions of section 403 require that food
producers disclose information about themselves or their products on the
labels or labeling of their products. Section 403(e) requires that the
label disclose the name and place of business of the food producer and
an accurate statement of the quantity of contents. Section 403(g)
requires that the label for a food for which a definition and standard
of identity has been prescribed by regulation must contain, as required
by regulations, the common names of optional ingredients. Section 403(h)
requires that the label of a food for which a standard of quality or a
standard of fill has been prescribed by regulations, and its quality or
fill falls below the standard of quality or fill, bear a statement that
it falls below such standard. Section 403(i) requires that the label of
a food product bear the common or usual name of the product, disclose
the names of the ingredients used in producing the food, and disclose
the amount of fruit or vegetable juice contained in the food if it is a
beverage containing fruit or vegetable juice. Section 403(j) requires
that the label of a food represented for special dietary uses must
contain such information concerning its vitamin, mineral, and other
dietary properties as prescribed by regulation. Section 403(q) requires
that the label or labeling for a food intended for human consumption
contain nutrition information. Section 403(r) provides that a health
claim or nutrient content claim may be made only if it is authorized in
a regulation or by action of the statute and provides for both a
petition or notification process whereby new claims are authorized. FDA
has issued various regulations in parts 101, 102, 104, and 105 (21 CFR
parts 101, 102, 104, and 105) that also require food producers to
disclose certain information on the labels of their food products.
Failure of a food producer to comply with the provisions of section 403
of the act or of parts 101, 102, 104, or 105 would result in the
specific product and the producer being subject to regulatory action.

The purpose of this request is to again assemble all of the current
information collection provisions contained in FDA's food labeling
regulations in parts 101, 102, 104,105, to consolidate the information
collection requirements with 0910-0357, "Reference Amount for Baking
Powder, Baking Soda, and Pectin".

FDA regulations in parts 101, 102, 104, and 105 (21 CFR parts 101, 102,
104, and 105) require food producers to disclose to consumers and others
specific information about themselves or their products on the label or
labeling of their products. These regulations were issued under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act
(the FPLA) (15 U.S.C. 1453, 1454, and 1455) and of sections 201, 301,
402, 403, 409, and 701 of the act (21 U.S.C. 321, 331, 342, 348, and
371). Most of the regulations in Parts 101, 102, 104, and 105 derive
from the requirements of section 403 of the act, which provides that a
food product shall be misbranded if, among other things, its label or
labeling fails to bear certain required information concerning the food
product, is false or misleading in any particular, or bears certain
types of unauthorized claims. Additionally, FDA has issued regulations
among parts 101, 102, 104, and 105 that require that food producers
retain records relative to the information contained in the label or
labeling of their products and provide those records to regulatory
officials. Finally, certain of the regulations issued by the agency
provide for the submission of petitions to FDA. Section 101.3 of FDA's
food labeling regulations requires that the label of a food product in
packaged form bear a statement of identity, (i.e., the name of the
product), including, as appropriate, the form of the food or the name of
the food imitated. Section 101.4 prescribes the requirements for the
declaration of ingredients on the label or labeling of food products in
packaged form. Section 101.5 requires that the label of a food product
in packaged form specify the name and place of business of the
manufacturer, packer, or distributor and, if the food producer is not
the manufacturer of the food product, its connection with the food
product. Section 101.9 requires that nutrition information be provided
for all food products intended for human consumption and offered for
sale, unless an exemption in § 101.9(j) applies to the product. Section
101.9(g)(9) provides for the submission to FDA of requests for
alternative approaches to nutrition labeling requirements. Finally, §
101.9(j)(18) provides for the submission to FDA of notices from firms
claiming the small business exemption from nutrition labeling. Section
101.10 requires that restaurants provide nutrition information, upon
request, for any food or meal for which a nutrient content claim or
health claim is made. Section 101.12(b) provides the reference amount
that is used for determining the serving sizes for specific products,
including baking powder, baking soda, and pectin. Section 101.12(e)
provides that a manufacturer that adjusts the reference amount
customarily consumed (RACC) of an aerated food for the difference in
density of the aerated food relative to the density of the appropriate
nonaerated reference food must be prepared to show FDA detailed
protocols and records of all data that were used to determine the
density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions to FDA to request changes in the reference
amounts defined by regulation.

Section 101.13 requires that nutrition information be provided in
accordance with the provisions of § 101.9 for any food product for which
a nutrient content claim is made. Under some circumstances, § 101.13
also requires the disclosure of other types of information as a
condition for the use of a nutrient content claim. For example, under §
101.13(j) if the claim compares the level of a nutrient in the food with
the level of the same nutrient in another \"reference\" food, the claim
must also disclose the identity of the reference food, the amount of the
nutrient in each food, and the percentage or fractional amount by which
the amount of the nutrient in the labeled food differs from the amount
of the nutrient in the reference food. It also requires that when this
comparison is based on an average of food products, this information
must be provided to consumers or regulatory officials upon request.
Section 101.13(q)(5) requires that restaurants

document and provide to appropriate regulatory officials, upon request,
the basis for any nutrient content claims they have made for the foods
they sell.

Section 101.14 provides for the disclosure of nutrition information in
accordance with § 101.9 and, under some circumstances, certain other
information as a condition for making a health claim for a food product.
Section 101.15 provides that, if the label of a food product contains
any representation in a foreign language, all words, statements, and
other information required by or under authority of the act to appear on
the label must appear in both the foreign language and in English.
Section 101.22 contains labeling requirements for the disclosure of
spices, flavorings, colorings, and chemical preservatives in food
products. Section 101.22(i)(4) sets forth reporting and recordkeeping
requirements pertaining to certifications for flavors designated as
containing no artificial flavors. Section 101.30 specifies the
conditions under which a beverage that purports to contain any fruit or
vegetable juice must declare the percentage of juice present in the
beverage and the manner in which the declaration is to be made.

Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in § 101.36(h)
applies. Section 101.36(f)(2) cross-references the provisions in §
101.9(g)(9) for the submission to FDA of requests for alternative
approaches to nutrition labeling requirements. Also, § 101.36(h)(2)
cross-references the provisions in § 101.9(j)(18) for the submission of
small business exemption notices.

Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and § 101.45 contains guidelines for providing such
information. Also, § 101.45(c) provides for the submission of nutrient
data and proposed nutrition labeling values for raw fruit, vegetables,
and fish to FDA for review and approval.

Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify information
that must be disclosed as a condition for making particular nutrient
content claims. Section 101.67 provides for the use of nutrient content
claims for butter, and cross-references requirements in other
regulations for information declaration (§ 101.4) and disclosure of
information concerning performance characteristics (§ 101.13(d)).
Section 101.69 provides for the submission of a petition requesting that
FDA authorize a particular nutrient content claim by regulation. Section
101.70 provides for the submission of a petition requesting that FDA
authorize a particular health claim by regulation. Section
101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber per serving
in the nutrition labeling of a food bearing a health claim about the
relationship between soluble fiber and a reduced risk of coronary heart
disease. Section 101.79(c)(2)(iv) requires the disclosure of the amount
of folate in the nutrition label of a food bearing a health claim about
the relationship between folate and a reduced risk of neural tube
defects.

Section 101.100(d) provides that any agreement that forms the basis for
an exemption from the labeling requirements of section 403(c), (e), (g),
(h), (i), (k), and (q) of the act be in writing and that a copy of the
agreement be made available to FDA upon request. Section 101.100 also
contains reporting and disclosure requirements as conditions for
claiming certain labeling exemptions.

Section 101.105 specifies requirements for the declaration of the net
quantity of contents on the label of a food in packaged form and
prescribes conditions under which a food whose label does not accurately
reflect the actual quantity of contents may be sold, with appropriate
disclosures, to an institution operated by a Federal, State or local
government. Section 101.108 provides for the submission to FDA of a
written proposal requesting a temporary exemption from certain
requirements of §§ 101.9 and 105.66 for the purpose of conducting food
labeling experiments with FDA authorization.

Regulations in part 102 define the information that must be included as
part of the statement of identity for particular foods and prescribe
related labeling requirements for some of these foods.

Part 104, which pertains to nutritional quality guidelines for foods,
cross references several labeling provisions in part 101 but contains no
separate information collection requirements.

Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in reducing
or maintaining body weight.

Attachment 1 lists 21 CFR Parts 101 through 169.

**2. How, by Whom, and for What Purpose Information is Used**

The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet. Additionally, FDA intends
to use the information to determine whether a manufacturer or other
supplier of food products is meeting its statutory and regulatory
obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the act
and parts 101, 102, 104, and 105 of FDA's food labeling regulations may
result in a product being misbranded under the act and the firm and the
product subject to regulatory action.

The information submitted to FDA as a nutrient content claim or health
claim petition will be used by the agency in reaching a finding as to
whether the petition meets the requirements of the regulations for the
issuance of regulations pertaining to nutrient content or health claims
and thereby ensuring that the public health is safeguarded. The
requirements in §§ 101.69 and 101.70 are those that FDA believes are
necessary to fulfill the requirements of the act.  The consequences of
not collecting the information required under these sections would be
the inability of the agency to determine whether the petition meets the
requirements of the regulation and whether the proposed claims are
justified.

The information submitted to FDA for a nutrient content claim or health
claim under the notification process will be used by FDA to assure that
a Scientific Body of the United States Government or the National
Academy of Sciences has published an authoritative statement which is
currently in effect about the level of the nutrient to which the
nutrient content claim refers or about the relationship between the
nutrient and the disease or health related condition to which the health
claim refers, and that the claim is an accurate representation of that
statement.

The information collections that will be reported to FDA under the
provisions of §§ 101.9(j)(18) and 101.36(h)(2) will be from small
businesses for the purpose of claiming an exemption from nutrition
labeling for low-volume food products. Under section 403(q)(5)(E) of the
act, a low-volume food product is exempt from the requirements for
nutrition labeling if it is the subject of a notice from a small
business claiming the exemption provided by the Nutrition Labeling and
Education Act Amendments of 1993. Those food products that are not the
subject of such a notice are not exempt from the mandatory nutrition
labeling requirements of section 403 (q) of the act unless the food
qualifies for another exemption. Section 403(q)(5)(E) of the act does
not require that the information in a notice claiming exemption be
reviewed by FDA for the exemption to be in effect.  However, FDA does
review the information in each notice to determine whether it meets the
requirements for the notice established in section 403(q)(5)(E)(iii) of
the act. FDA provides the information on the identity of firms
submitting notices claiming exemption to its field personnel and to
State enforcement agencies by posting the names and addresses of the
firms on a website maintained by the agency.

Information in petitions submitted under the provisions of § 101.12(h)
will be used by the agency in reaching a conclusion as to whether a new
reference amount should be established or an existing reference amount
should be amended. The consequence of not having this information is
that FDA would be restricted in obtaining the information necessary to
amend or add to the regulation on reference amounts.

Information submitted to FDA in response to the provisions for
alternative approaches contained in §§ 101.9(g)(9) and 101.36(f)(2) is
used by FDA to determine whether such alternative approaches would be
consistent with the requirements for nutrition labeling in section
403(q) of the act. The consequences of not having this information would
be a reduced flexibility of the manufacturer to use alternative
approaches for complying with the requirements of section 403(q) of the
act for the nutrition labeling of food products.

Data generated by the food labeling experiments permitted under §
101.108 may form the basis for a citizen's petition to amend the
existing food labeling regulations. The data could also be useful to FDA
for evaluating whether changes in current food labeling requirements are
warranted, and for developing alternative labeling formats that may be
useful to consumers and manufacturers. The extent of the collection of
information is determined by the firm proposing the labeling experiment,
and is of benefit to this firm. However, the labeling changes proposed
by a firm could not be implemented without supporting information
favoring the proposed changes.

**3. Use of Improved Information Technology**

The regulations in parts 101,102,104, and 105 do not specifically
prescribe the use of automated, electronic, mechanical, or other
technological techniques or other forms of information technology as
necessary for use by firms. Companies are free to use whatever forms of
information technology may best assist them in developing the proposed
notification.

**4. Identification of Duplication and Similar Information Already
Available**

No duplication of Federal regulations concerning the requirements for
the labeling of food products is likely because of the clear
Congressional authorization that FDA promulgate regulations pertaining
to the labeling of foods as opposed to the jurisdiction of the U.S.
Department of Agriculture (meats and poultry) and the Federal Trade
Commission (advertising).

**5. Small Business**

The requirements are the minimum requirements for complying with the
provisions of the act. In most cases, the information that is required
to be disclosed or submitted to the agency is information that is
available to a firm, including a small business, as a normal course of
its doing business. Any final rules become effective in accordance with
the agency's announcement concerning uniform compliance date. This would
provide firms with sufficient lead time to revise their labeling and to
dispose of any inventory of old labels. Additionally, small businesses
may claim exemption from the requirements for nutrition labeling,
including the requirement for providing serving size and number of
servings, under the provisions of 21 CFR 101.9(j)(18).

**6. Consequences if Data Were Collected Less Frequently**

There are no consequences to Federal program or policy activities if the
information is collected

less frequently. As noted above, failure of a firm to comply with the
requirements for disclosure

of the information on the labels or labeling of its food products may
result in those products being misbranded under section 403 of the act
and the products and the firm subject to regulatory action.

**7. Special Circumstances**

Not applicable.

**8. Outside Consultation**

In accordance with 5 CFR 1320.8(d), on October 31, 2003 (68 FR 62081), a
60-day notice for public comment (Attachment 2) was published in the
Federal Register.  No comments were received from the public

**9. Gifts**

This information collection does not provide for payment or gifts to
respondents.

**10. Confidentiality**

Information that is trade secret or confidential is subject to FDA\'s
regulations on the release of information, 21 CFR Part 20.

**11. Sensitive Questions**

This information collection does not involve any questions of a
sensitive nature.

**12. Respondent Hour Burden and Annualized Burden Hour Cost Estimates**

[Burden Hours]{.underline}

FDA estimates the burden of this collection of information as follows:

TABLE 1.\--ESTIMATED ANNUAL REPORTING BURDEN

  --------------------- ------------- ----------- ----------- ---------- --------- --------------
  21 CFR Sections and   No. of        Annual      Total       Hours per  Total     Total Capital,
  Parts                 Respondents   Frequency   Annual      Response   Hours     Operating, and
                                      per         Responses                        Maintenance
                                      Response                                     Costs

  101.3, 101.22, 102    17,000        1.03        17,500      0.5        8,750     0
  and 104                                                                          

  101.4, 101.22,        17,000        1.03        17,500      1          17,500    0
  101.100, 102, 104,                                                               
  and 105                                                                          

  101.5                 17,000        1.03        17,500      0.25       4,375     0

  101.9, 101.13(n),     17,000        1.03        17,500      4          70,000    \$1,000,000
  101.14(d)(3), 101.62,                                                            
  and 104                                                                          

  101.9(g)(9) and       12            1           12          4          48        0
  101.36(f)(2)                                                                     

  101.9(j)(18) and      10,000        1           10,000      8          80,000    0
  101.36(h)(2)                                                                     

  101.10                265,000       1.5         397,500     0.25       99,375    0

  101.12(b)             29            2.3         66          1          66        \$39,600

  101.12(e)             25            1           25          1          25        0

  101.12(g)             5,000         1           5,000       1          5,000     0

  101.12(h)             5             1           5           80         400       \$400,000

  101.13(d)(i) and      200           1           200         1          200       0
  101.67                                                                           

  101.13(j)(2),         2,500         1           2,500       1          2,500     0
  101.13(k), 101.54,                                                               
  101.56, 101.60,                                                                  
  101.61, and 101.62                                                               

  101.13(q)(5)          265,000       1.5         397,500     0.75       298,125   0

  101.14(d)(2)          265,000       1.5         397,500     0.75       298,125   0

  101.15                160           10          1,600       8          12,800    0

  101.22(i)(4)          25            1           25          1          25        0

  101.30 and 102.33     1,500         3.3         5,000       1          5,000     0

  101.36                300           40          12,000      4          48,000    \$15,000,000

  101.42 and 101.45     72,270        1           72,270      0.5        36,135    0

  101.45(c)             5             4           20          4          80        0

  101.69                3             1           3           25         75        0

  101.70                3             1           3           80         240       \$400,000

  101.79(c)(2)(ii)(D)   1,000         1           1,000       0.25       250       0

  101.79(c)(2)(iv)      100           1           100         0.25       25        0

  101.100(d)            1,000         1           1,000       1          1,000     0

  101.105 and           17,000        1.03        17,500      0.5        8,750     0
  101.100(h)                                                                       

  101.108               0             0           0           40         0         0

  Total                                                                  996,869   \$16,800,000
  --------------------- ------------- ----------- ----------- ---------- --------- --------------

TABLE 2.\--ESTIMATED ANNUAL RECORD KEEPING BURDEN

+-----------------+--------+---------+--------+-------+-------+-------+
| 21 CFR Sections | No. of | Annual  | Total  | Hours | Total | Total |
| and Parts       | Record | Fr      | Annual | per   | Hours | Cap   |
|                 | k      | equency | R      | R     |       | ital, |
|                 | eepers | per     | ecords | ecord |       | Opera |
|                 |        | Record  |        |       |       | ting, |
|                 |        |         |        |       |       | and   |
|                 |        | keepers |        |       |       | M     |
|                 |        |         |        |       |       | ainte |
|                 |        |         |        |       |       | nance |
|                 |        |         |        |       |       | Costs |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.12(e)       | 25     | 1       | 25     | 1     | 25    | 0     |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.13(q)(5)    | 2      | 1.5     | 3      | 0.75  | 29    | 0     |
|                 | 65,000 |         | 97,500 |       | 8,125 |       |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.14(d)(2)    | 2      | 1.5     | 3      | 0.75  | 29    | 0     |
|                 | 65,000 |         | 97,500 |       | 8,125 |       |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.22(i)(4)    | 25     | 1       | 25     | 1     | 25    | 0     |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.100(d)(2)   | 1,000  | 1       | 1,000  | 1     | 1,000 | 0     |
+-----------------+--------+---------+--------+-------+-------+-------+
| 101.105(t)      | 100    | 1       | 100    | 1     | 100   | 0     |
+-----------------+--------+---------+--------+-------+-------+-------+
| Total           |        |         |        |       | 59    | 0     |
|                 |        |         |        |       | 7,400 |       |
+-----------------+--------+---------+--------+-------+-------+-------+

These estimates are based on FDA's \"Regulatory Impact Analysis of the
Final Rules to Amend the Food labeling Regulations,\" the agency's most
recent comprehensive review of food labeling costs, that published in
the Federal Register of January 6, 1993 (58 FR 2927); agency
communications with industry, and FDA's knowledge of and experience with
food labeling and the submission of petitions and requests to the
agency. Where an agency regulation implements an information collection
requirement in the act or the FPLA, only any additional burden
attributable to the regulation has been included in FDA's burden
estimate.

FDA expects that the burden hours for submissions under § 101.108 will
be insignificant. Section 101.108 was originally promulgated to provide
a procedure whereby FDA could grant exemptions from certain food
labeling requirements. Exemption petitions have infrequently been
submitted in the recent past; none have been submitted since publication
on January 6, 1993, of the final regulations implementing section 403(q)
and (r) of the act. FDA is retaining § 101.108 in its regulations for
the possibility that a food producer may propose to conduct a labeling
experiment on its own initiative. At this time, however, FDA considers
this possibility sufficiently unlikely that the hour burden may be
considered to be insignificant.

No burden has been estimated for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, no burden has been estimated for that information that is
disclosed to third parties as a usual and customary part of a food
producer's normal business activities. Under 5 CFR 1320(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not a collection of information. Under 5 CFR 1320.3(b)(2), the time,
effort, and financial resources necessary to comply with a collection of
information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.

[Estimated Annualized Cost for the Burden Hours]{.underline}

FDA estimates that the annualized cost to respondents associated with
the requirements of parts 101, 102, 104, and 105 of the regulations to
be \$59,136,180 for reporting and \$38,844,000 for recordkeeping, for a
total annualized cost of \$94,980,180. This estimate is based on the
base hourly rate of a GS-13 salary (\$30.00) plus overhead expenses
estimated as being equal to salary for a total hourly cost of \$60.00.
This also includes the burden to firms of initially complying with the
requirements of the provisions that relate to restaurants and to dietary
supplements. Once firms are in compliance with these provisions, the
burden would drop significantly as firms would be expected to revise
labels or other labeling information only as new products are introduced
into the marketplace or the composition of existing products is changed.

**13. Annual Cost Burden to Respondent**

Operating and maintenance costs (\$16,000,000) associated with this
collection are limited to the operating costs necessary to produce
labels for food products that have undergone changes in their
composition or that are initially being introduced into the marketplace
and to bring the labels or labeling of existing dietary supplements into
compliance with the new requirements for nutrition labeling and the
disposal of noncomplying inventories of labels or labeling. Capital
costs (\$800,000) are those that might be incurred in conjunction with
the development of information to support petitions for new reference
amounts (§ 101.12(h)), new nutrient content claims (§ 101.69), or for
new health claims (§ 101.70).

**14. Annualized Cost to the Federal Government**

In FDA's field compliance program for FY-1999, FDA utilized 14.7 person
years to inspect firms and collect and analyze samples of conventional
foods to determine compliance with the various food labeling provisions.
Based on an average person-year cost of approximately \$100,000 and
including an allowance for overhead, FDA estimates that this amount of
time translates to a cost to the Federal Government of approximately
\$2,646,000 per year. FDA estimates that an additional one person year
at an estimated cost of \$180,000 would be required to respond to
violations involving conventional foods.

In the Federal Register of September 23, 1997, FDA published a final
rule entitled \"Food Labeling; Statement of Identity, Nutrition Labeling
and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide,
Revocation\" in which it estimated the cost to the Federal government to
inspect firms and to collect and analyze samples to determine compliance
with the newly established requirements for dietary supplements to be
approximately 14.2 person years. Based on an average person-year cost of
approximately \$100,000 and an allowance for overhead, the Agency
estimates that this amount of time translates to a cost to the Federal
Government of \$2,556,000 per year. FDA further estimates that as much
as one person-year at an estimated cost of \$180,000 would be required
to respond to violations involving dietary supplements.

Six of the regulations contain provisions for the submission of
petitions or notices to FDA. FDA estimates that a total of over 7100
hours would be expended in the review of these submissions. At an
estimated rate for a GS-13, with overhead estimated to be equal to the
hourly rate, the hourly cost for the review and evaluation of the
various submissions is estimated to be approximately \$60 per hour for a
total estimated cost to the Federal Government of more than \$426,000.
FDA estimates that the total cost to the Federal Government of the
provisions contained in this information collection to be approximately
\$5,988,000.

**15. Changes or Adjustments in Burden**

The increase in the hour burden is due to the consolidation of the
burden hours in 0910-0357, in addition to a readjustment of the burden
for 0910-0381.

**16. Statistical Analysis, Publication Plans, and Schedule**

Not Applicable

**17. Approval Not to Display Expiration Date**

There are no reasons why display of the expiration date for OMB approval
of the information collection would be inappropriate.

**18. Exceptions to the Certification Statement Identified in Item 19**

No exceptions to the certification statement identified in Item 19 of
the instructions for completing OMB Form 83-I have been identified.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

There are no plans to publish the information collected under the
provisions of this proposed regulation for statistical use. The
collection of information required under the provisions of this proposed
regulation do not employ statistical methods.