Table 4 11 illustrates some examples of " Use in Children's Product." For example, EPA believes that certain products, like crayons, coloring books, diapers, and toy cars  to name a few  are typically to be used by children age 14 or younger. As such, if you determine, based on readily obtainable information, that your chemical substance or mixture is used in crayons and toy cars, report a " Y" in the Children's Product column for categories C01 and C10.

Certain products, such as household cleaning products, automotive supplies, and lubricants, are not typically intended to be used by children age 14 or younger. As such, if you determine, based on readily obtainable information, that your chemical substance or mixture is used in automotive care products and lubricants, report an " N" in the Children's Use column for categories C03 and C09.

Table 4 11. Examples of Use in Children's Product Codes Category Examples C01 Artists' supplies Crayons, children's markers C02 Adhesives and sealants Craft glue, model glue C03 Automotive care products Typically products in this category are not likely to be intended for use by children 14 or younger C04 Electrical and electronic products Electronic games, remote control cars, toys C05 Glass and ceramic products Porcelain dolls C06 Fabrics, textiles and apparel Pajamas C07 Lawn and garden products ( non pesticidal) Lawn & gardening tools designed specifically for children, e. g., kids rake C08 Leather products Shoes, jackets, baseball gloves C09 Lubricants, greases and fuel additives Typically products in this category are not likely to be intended for use by children 14 or younger C10 Metal products Toy trucks, toy cars, wagon C11 Paper products Diapers, baby wipes, coloring books Table 4 11 ( Continued) DRAFT: Chapter 4.0 Completing Form U Codes Category Examples 4 19 C12 Paints and coatings Finger paints, water color kits intended for children's use C13 Photographic chemicals Typically products in this category are not likely to be intended for use by children 14 or younger C14 Polishes and sanitation goods Typically products in this category are not likely to be intended for use by children 14 or younger C15 Rubber and plastic products Pacifiers, action figures, balls C16 Soaps and detergents Baby shampoo, children's bubble bath C17 Transportation products Child's car seat C18 Wood and wood furniture Baby cribs, changing tables, wooden toys C19 Other Other items specifically intended for use by children age 14 or younger <IP_ADDRESS> Percentage of Production Volume. You are required to estimate the percentage of your production volume for each reportable chemical substance that is attributable to each specific commercial and consumer end use carried out at sites under your control, as well as at sites that receive a reportable chemical substance from you either directly or indirectly ( including through a broker/ distributor, from a customer of the submitter, etc.), to the extent that such information is readily obtainable ( 40 CFR 710.52( c)( 4)( ii)( C)). Round estimates to the nearest 10 percent of production volume ( 40 CFR 710.52( c)( 4)( ii)( C)). However, you may not round a commercial and consumer product category that accounts for 5 percent or less of the total production volume of a reportable chemical substance to 0 percent if the production volume attributable to that commercial and consumer product category is greater than or equal to 300,000 pounds ( 40 CFR 710.52( c)( 4)( ii)( C)). In such cases, you must report the percentage of production volume attributable to that commercial and consumer product category to the nearest 1 percent of the production volume ( 40 CFR 710.52( c)( 4)( ii)( C)). This exception to the general rounding rule will ensure that adequate use information is reported for gross production volumes of chemical substances. EPA selected the 300,000 pound threshold for consistency with the proposed threshold for reporting processing and use data. To claim this information as confidential for this substance, check the CBI box.

The total percentage of production volumes reported may add up to more than 100 percent, given that you are reporting production volumes to the nearest 10 percent. The total percentage of production volume may add up to less than 100 percent if you cannot readily obtain information about how all of your production volume is used in commercial and consumer products or there are more than 10 commercial or consumer product categories applicable to your chemical substance.

<IP_ADDRESS> Maximum Concentration Code. You are required to report estimates, in ranges, of the maximum concentration ( measured by weight) of each reportable chemical DRAFT: Chapter 4.0 Completing Form U 4 20 substance likely to be present in commercial and consumer products manufactured ( including imported) at sites under your control and at sites where your commercial and consumer products are distributed directly or indirectly ( including through a broker/ distributor, from a customer, etc.) ( 40 CFR 710.52( c)( 4)( ii)( D)). Such information is required only to the extent that it is readily obtainable by you; otherwise leave the box corresponding to this data element blank. The reporting range codes are the same as those listed in Table 4 4. To claim this information as confidential, check the CBI box. DRAFT: Chapter 5.0 How to Assert Confidentiality Claims 5 1 5.0 How to Assert Confidentiality Claims Under the proper circumstances, information submitted to EPA under the IUR can be claimed confidential. However, such claims will not be accepted and honored if they are not asserted at the time information is submitted to EPA or if they are submitted in a manner inconsistent with the rule and reporting instructions.

You can claim certain information submitted to EPA under this rule as confidential if you believe that doing so is warranted under the substantive criteria for determining confidentiality found within 40 CFR 2.208. EPA's procedures for processing and reviewing confidentiality claims are set forth at 40 CFR Part 2, Subpart B. EPA strongly encourages you to review confidentiality claims carefully to ensure that the information in question falls under the protection of TSCA section 14 and fully meets the substantive criteria within the Part 2 regulations referred to above.

To claim information as confidential, you must check the appropriate boxes on Form U and have an authorized official sign the certification statement on the reporting form ( 40 CFR 710.58( a)). If you fail to do so, EPA could release the information to the public without further notice to you. As reflected in the regulations, by signing the certification statement you certify that your claims of confidentiality are made in good faith. Procedures for claiming information submitted electronically ( such as a submission on diskette) as confidential are specified in Chapter 6. CBI must not be submitted by e mail. See Section <IP_ADDRESS> for CBI packaging instructions.

Specific procedures for CBI claims of chemical identity, manufacturing plant and plant site information, and chemical production volume information are addressed below. Table 5 1 summarizes the special considerations for these data elements.

Table 5 1. Special Considerations for Asserting Confidentiality Claims Data Element Confidentiality Claim Requirement Chemical Identity Check CBI box in Part II Section A, and submit answers to questions in Table 5 2. See 40 CFR 710.58( b)( 1).

Manufacturing Plant Site Identity Check CBI box in Part II Block 2. B. 2 and submit written answers to questions in Table 5 3. See 40 CFR 710.58( c)( 1).

Chemical Production Volume Check the CBI box in Part II Block 2. B. 5 and determine if CBI protection is warranted for the corresponding range listed in Table 5 4. If the range also warrants CBI protection, check the CBI box in Block 2. B. 6. DRAFT: Chapter 5.0 How to Assert Confidentiality Claims 5 2 5.1 Chemical Identity You may assert a confidentiality claim for the specific identity of a chemical substance only if EPA treats that substance identity as confidential in the TSCA Inventory at the time your report is submitted ( i. e., the substance is not on the Public Inventory) ( 40 CFR 710.58( b)). Both confidential and nonconfidential substances can be included in the same submission. Confidential substances can be included in diskette submissions ( see Chapter 6 for further discussion of diskette submission procedures).

A claim of confidentiality for the identity of a chemical will not be accepted unless accompanied by a separate written substantiation for each chemical substance claimed as CBI. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must submit detailed written answers to the questions at 40 CFR 710.58( b)( 1), which are repeated in Table 5 2. In addition, an authorized official from your company must sign and date Form U. The answers must be complete and specific to the chemical substance in question. If any of the information contained in the answers to these questions is asserted to contain CBI, you must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as " confidential business information," " proprietary," or " trade secret" ( 40 CFR 720.25). If the required substantiation does not accompany your Form U, EPA may make the chemical identities reported on the form available to the public without further notice to you. See Section <IP_ADDRESS> for CBI packing instructions.

If you are manufacturing or importing a chemical substance that is currently listed in the TSCA Inventory as confidential, you are encouraged not to assert confidentiality claims if circumstances are now such that confidentiality is no longer necessary. If you report a previously confidential substance as nonconfidential, that substance will subsequently be listed in the TSCA Inventory as nonconfidential.

Table 5 2. Substantiation Questions To Be Answered When Making Chemical Identity CBI Claims ( from 40 CFR 710.58( b))

No. Question 1. What harmful effects to your competitive position, if any, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under the IUR? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

2. How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

3. Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented, and therefore disclosed through the patent, why should it be treated as confidential?

4. Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone? Table 5 2 ( Continued) DRAFT: Chapter 5.0 How to Assert Confidentiality Claims No. Question 5 3 5. Is the fact that the chemical substance is being manufactured ( including imported) for a commercial purpose available to the public, for example, in technical journals, libraries, or State, local, or Federal agency public files?

6. What measures have you taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured ( including imported) for a commercial purpose?

7. To what extent has the fact that this chemical substance is manufactured ( including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

8. Does this particular chemical substance leave the site of manufacture ( including import) in any form ( e. g., as product, effluent, emission)? If so, what measures have been taken to guard against the discovery of its identity?

9. If the chemical substance leaves the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product?

10. For what purpose do you manufacture ( including import) the substance?

11. Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

5.2 Manufacturing Plant Site Identity Under the IUR, you may assert a claim of confidentiality for the identity of the manufacturing facility if release of that identity would reveal confidential business information as contemplated under Section 14 of TSCA. EPA believes claims for CBI should be limited to circumstances in which they are absolutely necessary and legally justified.

To assert a claim of confidentiality, you are required to check the CBI box at Block 2. B. 2 of Part II on the reporting form indicating a confidentiality claim for plant site identity information and you are required to substantiate that claim ( 40 CFR 710.58( c)). To do this, you must submit with Form U detailed written answers to the two questions at 40 CFR 710.58( c)( 1), which are also listed in Table 5 3. In addition, an authorized official from your company must sign and date Form U ( 40 CFR 710.58( c)( 1)). This upfront substantiation is not required for company information CBI claims ( Block 2. B. 1 on Form U). Please note that both plant site and company information claims are to be made in conjunction with a specific chemical substance on page 2 of Form U. For instance, if you report four chemical substances on one Form U ( by photocopying additional pages of Part II and III) you are able to claim CBI for plant site identity for one chemical while releasing information for the other three. DRAFT: Chapter 5.0 How to Assert Confidentiality Claims 5 4 Table 5 3. Substantiation Questions To Be Answered When Making Plant Site Identity CBI Claims No. Question 1. Has site information been linked with a chemical identity in any other Federal, state, or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the EPCRA section 311, namely through a Material Safety Data Sheet ( MSDS)? If so, identify all such schemes. Was the linkage claimed as confidential in any of these instances?

2. What harmful effect, if any, to your competitive position do you think would result from disclosure of the identity of the site and the chemical substance? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

If you assert that any of the information contained in the answers to these questions contains CBI, you must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as " confidential business information," " proprietary," or " trade secret" ( 40 CFR 720.25). If no claim of confidentiality is indicated on the Form U submitted to EPA under this part, or if confidentiality claim substantiation is not submitted with Form U , EPA may make the information available to the public without further notice to you. See Section <IP_ADDRESS> for CBI packaging instructions.

5.3 Chemical Production Volume Information Under the IUR, you may check the appropriate box on Form U to assert a claim of confidentiality for chemical production volume information, if the information qualifies as confidential under Section 14 of TSCA and the substantive criteria under 40 CFR Part 2. Additionally, if you do assert a claim of confidentiality for your specific production volume, you may also choose to determine if CBI protection is warranted for production volume information in ranges. The ranges are similar to those used for the original TSCA Inventory and are listed in Table 5 4. If you determine that your production volume range also warrants CBI protection, you must check the appropriate box on Form U for claiming this information as CBI ( 40 CFR 710.58( a)).

Table 5 4. Production Volume Ranges Production Volume Ranges ( in pounds)

At least 25,000 but less than 300,000 At least 300,000 but less than 1,000,000 At least 1,000,000 but less than 10,000,000 At least 10,000,000 but less than 50,000,000 At least 50,000,000 but less than 100,000,000 At least 100,000,000 but less than 500,000,000 At least 500,000,000 but less than 1,000,000,000 DRAFT: Chapter 5.0 How to Assert Confidentiality Claims Production Volume Ranges ( in pounds)

5 5 1,000,000,000 or greater 5.4 Additional Data Elements You may claim the information reported under the IUR confidential. Form U contains confidential business information ( CBI) boxes for the data elements requested in Parts II and III of the Form. To assert a claim of confidentiality enter an " X" in the CBI box for that data element as discussed in Section 4.0. DRAFT: Chapter 6.0 How to Submit Your Report to EPA 6 1 6.0 How to Submit Your Form U to EPA EPA will mail a reporting package ( consisting of a copy of Form U and a copy of the Instructions for Reporting for Partial Updating of the TSCA Inventory Data Base) to those companies that reported in the IUR reporting period that occurred immediately prior to the current reporting period. If you did not receive a reporting package but are required to report, you may request a copy of the reporting package from EPA by calling the EPA TSCA Hotline at ( 202) 554 1404 or TDD ( 202) 554 0551, or you may send an e mail message to the EPA TSCA Hotline at TSCA Hotline@ epa. gov. If you wish to send a written request for this information, write to:

TSCA Hotline Mail Code 7408M ATTN: Inventory Update Rule Office of Pollution Prevention and Toxics Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460.

6.1 Sending Forms to EPA You must use the EPA form identified as " Form U" to submit written information in response to the requirements of this rule ( 40 CFR 710.59( a)). Section 7.3 presents the procedures for obtaining copies of Form U.

You must submit your completed written and/ or electronic reporting form( s), along with the accompanying Certification Letter and CBI Substantiation Letter, to EPA at the following address ( 40 CFR 710.59( d)):

OPPT Document Control Officer Mail Code 7407M ATTN: Inventory Update Rule Office of Pollution Prevention and Toxics Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460. DRAFT: Chapter 6.0 How to Submit Your Report to EPA 6 2 Note: The act of correcting errors in submissions to the Original Inventory does not grant the person making the correction immunity from enforcement action for any possible violations of the Original Inventory Reporting Rule. 6.2 Correcting Errors in Submissions for Original Inventory In reporting under the IUR, you may find that an error was made when you reported for the original Inventory. That error may fall into one of the following categories:

The chemical identity originally reported was incomplete or inaccurate;

An isolated intermediate produced during the manufacture of a substance was not recognized when previously reported for the Inventory; or

EPA informed your company of a reporting error and requested a correction from you, to which you did not respond.

If an error occurred, you should file an Inventory Correction, following the procedures outlined in the Federal Register notice of July 29, 1980 ( 45 FR 50544). Reference the original Inventory report form and line number ( if appropriate) when you file a correction. For copies of the Federal Register notice or further assistance with an Inventory Correction, you may contact:

TSCA Hotline U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics ( 7408) Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Telephone: ( 202) 554 1404 Submit your Inventory Correction requests to EPA with your copies of Form U. Your Form U should report the chemical substance you are actually manufacturing or importing. Explain the correction in a cover letter that specifically references the number of the correction form, the Form U number, and the Form U report line number. Please note that the act of correcting errors in submissions to the Original Inventory does not grant the person making the correction immunity from enforcement action for any possible violations of the Original Inventory Reporting Rule.

6.3 Recordkeeping Requirements The Inventory regulations require you to retain records on IUR reports for 5 years after the effective date of the applicable reporting period ( 40 CFR 710.57). For example, if you submit an IUR report in reporting year 2006, you would be required to retain the records on which the report is based until December 23, 2011.

As long as the records are maintained in a manner consistent with normal business practice, you may determine their exact format. Required records include those that show the DRAFT: Chapter 6.0 How to Submit Your Report to EPA 6 3 production volume, plant site, and site limited status of each substance reported. If a substance is not reported because its site specific annual production is less than 25,000 pounds, EPA suggests you maintain records to document your reasons for not filing Form U.

If you qualify as an exempt small manufacturer, you need to keep records only for those chemical substances that you are required to report; however, in claiming an exemption, you bear the burden of documenting that you qualify for the exemption.

6.4 Special Instructions for Importers and Foreign Suppliers This section applies to importers who do not know the specific chemical identity of a substance because the foreign supplier chooses to keep it confidential. If you are such an importer, you are still responsible for ensuring that the information is submitted to EPA ( 40 CFR 720.25). You can accomplish this by having your foreign supplier complete some of the information on Form U, as follows:

1. Include a cover letter with your Form U, stating, " The identifying numbers and specific chemical identities for the substances on this form and the technical contact will be submitted by our foreign supplier."

2. Use a separate Form U for each foreign supplier who does not inform you of the identity of the chemical substances you are importing. Do not report by diskette. Do not use the same report form for substances for which you know the specific identity.

3. Photocopy a blank Form U before entering any information on the form.

4. On the original form, sign the certification statement, enter the technical contact, and complete Parts I through IV for each chemical substance. In Part II, Section I, Block 2. A. 1, instead of entering the identifying number, enter the trade name or other designation by which you know each chemical substance. Leave Block 2. A. 2 blank. Check the " Chemical CBI" box only if you wish to claim the identities of the chemicals identified on the form as confidential ( you must answer the substantiation questions described in Section 5.1). Foreign suppliers are responsible for their own CBI claims. Send this original form to EPA.

5. On the photocopy of the blank form, enter only the plant site information. Send this copy to your foreign supplier to complete and forward to EPA.

6. The foreign supplier should enter technical contact company information on the copy ( the technical contact listed here should be the foreign supplier), complete Parts I through IV, and enter the appropriate specific chemical identities in Part II, Section I. Make sure that your supplier understands which chemical identities belong with each copy of the Form U. If the foreign supplier wishes to claim the chemical identities as confidential, the supplier should check the " CBI" box and submit a substantiation as described in Section 5.1. The supplier should include with Form U a letter stating that this information is being submitted by a foreign DRAFT: Chapter 6.0 How to Submit Your Report to EPA 6 4 supplier on behalf of the importer, who should be identified. Information in the letter may be claimed as confidential by circling or bracketing the text to be protected and marking the page " CONFIDENTIAL." Failure to so mark this information may result in EPA making the information available to the public without further notice to the supplier. The foreign supplier should then send the form and letter to EPA.

Note that it is your responsibility to ensure that your foreign supplier understands how to complete the copy of Form U ( including any relevant CBI claims) and that the supplier sends the information to EPA by the end of the reporting period. If the supplier fails to submit the information, your company may be subject to an enforcement action. DRAFT: Chapter 7.0 How to Obtain Copies of Documents Cited in These Instructions 7 1 7.0 How To Obtain Copies of Documents Cited in These Instructions 7.1 Obtaining Copies of TSCA Regulations To obtain copies of TSCA regulations, write to:

TSCA Hotline U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics ( 7408M) Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Or call ( 202) 554 1404 for assistance.

7.2 Obtaining Copies of the Public Inventory 7.2.1 Printed Editions of the Public Inventory The nonconfidential Public Inventory listing can be found in the TSCA Chemical Substance Inventory: 1985 Edition ( a complete version of the Public Inventory current as of July 1985) and in the TSCA Chemical Substance Inventory: 1990 Supplement, a supplement to the 1985 edition current as of February 1, 1990. These printed versions contain the CAS Registry Number, CA Index/ Preferred Name, molecular formula, and, if applicable, the substance definition and appropriate EPA flags ( including the " XU" flag for substances previously exempt from reporting under the IUR) for nonconfidential substances. For chemical substances the chemical identity of which has been claimed as confidential, generic chemical names and EPA accession numbers are listed.

7.2.2 Obtaining the Public Inventory in Computer Readable Format The Public Inventory is available on computer tape, diskettes, and CD ROM. These can be obtained from the National Technical Information Service ( 703 487 4650). The computer tape version consists of two tapes. The first tape, the Inventory Preferred Name File, is sorted by CAS Registry Number. It contains the CAS Registry Number, CA Index/ Preferred Name, molecular formula, and if applicable, the substance definition and appropriate EPA flags ( including the " XU" flag for substances exempt from reporting under the Inventory Update Rule) for nonconfidential substances. The second tape, the Inventory Synonym Name file, contains the DRAFT: Chapter 7.0 How to Obtain Copies of Documents Cited in These Instructions 7 2 same data elements as the first tape but differs in two ways. First, it is sorted by chemical name, not CAS Registry Number. Second, in addition to the CA Index/ Preferred names, this file also includes valid names ( synonyms) as supplied to EPA by Inventory submitters. In contrast to the printed version of the Public Inventory, which includes CAS derived synonyms, the synonyms listed on this tape are only those reported to EPA by Inventory submitters.

The CD ROM version contains the information on both computer tapes combined, with duplicate information removed. CAS Registry Numbers are listed in numerical order.

The tapes and CD ROM only contain information on nonconfidential chemical substances. They do not refer in any way to chemicals on the TSCA Inventory claimed as confidential.

Contact the following for ordering information for these products:

National Technical Information Service 5285 Port Royal Road Springfield, VA 22161 Telephone: ( 703) 487 4650 or ( 800) 553 NTIS 7.3 Obtaining Copies of Form U Electronic and printed copies of Form U can be obtained from:

TSCA Hotline U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics ( 7408M) Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Telephone: ( 202) 554 1404 DRAFT: Chapter 8.0 How to Request Assistance with Reporting 8 1 8.0 How To Request Assistance with Reporting Write to the address below if you need additional information on or assistance with:

Determining your reporting obligations;

Mechanics of completing Form U;

Entering data onto a computer diskette for submission; and

Determining the status of forms/ diskettes you have submitted.

TSCA Hotline U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics ( 7408M) Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Attn: Inventory Update Rule.

You can also call ( 202) 554 1404 for assistance.


[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14472-14473]
[FR Doc No: 2018-06807]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2018-0020; OMB No. 1660-0030]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Manufactured Housing Operations Forms

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public to take this opportunity to comment on an extension,
without change, of a currently approved information collection. In
accordance with the Paperwork Reduction Act of 1995, this notice seeks
comments concerning the collection of information related to FEMA's
temporary housing assistance, which provides temporary housing to
eligible survivors of federally declared disasters. This information is
required to determine whether a potential site supports the
installation of a temporary housing unit, to obtain permission to place
the temporary housing unit on the property, to allow ingress and egress
to the property where the temporary housing unit is placed, and to
document the installation and maintenance of the unit.

DATES: Comments must be submitted on or before June 4, 2018.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2018-0020. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID: FEMA-2018-0020. Regardless of the method used for submitting
comments or material, all submissions will be posted, without change,
to the Federal eRulemaking Portal at http://www.regulations.gov, and
will include any personal information you provide. Therefore,
submitting this information makes it public. You may wish to read the
Privacy Act notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Elizabeth McDowell, Supervisory
Program Specialist, FEMA, Recovery Directorate, at<PHONE_NUMBER>. You
may contact the Information Management Division for copies of the
proposed collection of information at email address: [email protected].

SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5174) authorizes the President to
provide temporary housing units to include mobile homes and other
readily fabricated dwellings to eligible applicants who require
temporary housing as a result of a major disaster. 44 CFR part 206
provides the requirements and procedures for delivering temporary
housing assistance to eligible individuals and households with
disaster-related housing needs. The information collected provides the
facts necessary to determine the feasibility of a potential site for
placement of a Temporary Housing Unit (THU), to ensure the landowner
will allow for a Mobile Housing Unit (MHU) to be placed on the
property, and to document the installation and maintenance of the unit.
FEMA is requesting an extension, without change, of a currently
approved information collection.

Collection of Information

    Title: Manufactured Housing Operations Forms.
    Type of Information Collection: Extension without change of a
currently approved information collection.
    OMB Number: 1660-0030.
    FEMA Forms: FEMA Form 010-0-9, Request for the Site Inspection;
FEMA Form 010-0-10, Landowner's Authorization Ingress-Egress Agreement;
FEMA Form 009-0-130, Manufactured Housing Unit Maintenance Work Order;
FEMA Form 009-0-136, Manufactured Housing Unit Installation Work Order;
FEMA Form 009-0-138, Manufactured Housing Unit Inspection Report.
    Abstract: The Robert T. Stafford Disaster Relief and Emergency
Assistance Act authorizes the President to provide temporary housing
units in the form of manufactured housing, recreational vehicles or
other readily fabricated dwellings to eligible applicants who require
direct temporary housing as a result of a major disaster. The
information collected is necessary to determine the feasibility of the
site for placement of temporary housing and to provide FEMA with access
to place the temporary housing unit as well as retrieve it at the end
of the use.
    Affected Public: Individuals or households, Business or other for-
profits.
    Estimated Number of Respondents: 25,000.
    Estimated Number of Responses: 25,000.
    Estimated Total Annual Burden Hours: 4,167.50.
    Estimated Total Annual Respondent Cost: $189,830.
    Estimated Respondents' Operation and Maintenance Costs: 0.
    Estimated Respondents' Capital and Start-Up Costs: 0.
    Estimated Total Annual Cost to the Federal Government: $2,165,310.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: March 27, 2018.
Rachel Frier,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2018-06807 Filed 4-3-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18552-18554]
[FR Doc No: 2023-06485]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0187]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by April 28, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0231. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Revision

    This information collection supports implementation of statutory
and regulatory requirements that govern premarket approval of medical
devices. Premarket approval is the FDA process of scientific and
regulatory review to evaluate the safety and effectiveness of class III
medical devices. Class III devices are those that support or sustain
human life, are of substantial importance in preventing impairment of
human health, or which present a potential, unreasonable risk of
illness or injury. Due to the level of risk associated with class III
devices, FDA has determined that general and special controls alone are
insufficient to assure the safety and effectiveness of class III
devices. Therefore, these devices require a premarket approval
application (PMA) under section 515 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360e) to obtain marketing approval.
PMA requirements apply differently to preamendments devices,
postamendments devices, and transitional class III devices and some
class III preamendment devices may require a class III 510(k). (See the
PMA Historical Background web page at https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background for additional
information.) Section 515A of the FD&C Act (21 U.S.C. 360e-1) governs
pediatric uses of devices.
    The PMA is the most stringent type of device marketing application
required by FDA. Applicants must receive FDA approval of a PMA prior to
marketing the device. PMA approval is based on a determination that the
PMA contains sufficient valid scientific evidence to assure that the
device is safe and effective for its intended use(s). Respondents to
the information

collection are PMA applicants, or persons who own the rights, or
otherwise have authorized access, to the data and other information to
be submitted in support of FDA approval. This person may be an
individual, partnership, corporation, association, scientific or
academic establishment, government agency or organizational unit, or
other legal entity. The applicant is often the inventor/developer and
ultimately the manufacturer. A class III device that fails to meet PMA
requirements is considered to be adulterated under section 501(f) of
the FD&C Act (21 U.S.C. 351(f)) and may not be marketed.
    FDA regulations in part 814 (21 CFR part 814) implement section 515
and 515A of the FD&C Act and establish procedures for the premarket
approval of medical devices intended for human use, including the
submission of information concerning use in pediatric patients.
Regulations in part 814, subpart A (21 CFR 814.1 to 814.19) set forth
general provisions pertaining to the confidentiality of data and
information submitted to FDA in a PMA, research conducted outside the
United States, service of orders, and product development protocols
(PDPs). Provisions in part 814, subparts B and C (21 CFR 814.20 to
814.47) establish format and content elements that must be included in
an application, explain submission and review schedules, and address
the withdrawal and temporary suspension of a PMA. Postapproval
requirements, including reports required under 21 CFR part 803 (medical
device reporting), are covered in regulations in part 814, subpart E
(21 CFR 814.80 to 814.84). Burden attributable to information
collection associated with regulations in part 814, subpart H (21 CFR
814.100 to 814.126) pertaining to Humanitarian Use Devices is currently
approved in OMB control number 0910-0332.
    For operational efficiency, we are revising the information
collection to include burden that may be associated with
recommendations found in the Agency guidance document entitled
``Providing Information about Pediatric Uses of Medical Devices'' (May
2014), currently approved in OMB control number 0910-0748. The guidance
document describes how to compile and submit the readily available
pediatric use information required under section 515A of the FD&C Act.
The guidance document is available for download from our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices.
    Relatedly, we are revising the information collection to include
burden that may be associated with the submission of information on
pediatric use of medical devices under section 515A of the FD&C Act,
also currently approved in OMB control number 0910-0748. Section
515A(a) of the FD&C Act requires applicants who submit information to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This information allows FDA to track the
number of approved devices for which there is a pediatric subpopulation
that suffers from the disease or condition that the device is intended
to treat, diagnose, or cure and the review time for each such device
application.
    We are also revising the information collection to include burden
applicable to implementing requirements under section 402(j)(5)(B) of
the Public Health Service (PHS) Act (42 U.S.C. 282(j)(5)(b)), and set
forth in regulations at 42 CFR part 11 (see 81 FR 64981, September 21,
2016). Specifically, applications under sections 505, 515, or 520(m) of
the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of
the PHS Act (42 U.S.C. 262), or submission of a report under section
510(k) of the FD&C Act, must be accompanied by a certification. Where
available, such certification must include the appropriate National
Clinical Trial numbers. We have developed Form FDA 3674
(``Certifications to Accompany Drug, Biological Product, and Medical
Device Applications/Submissions''), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions, for respondents to submit the requisite
information.
    Respondents can make single submissions in an electronic format
that includes eCopies, submissions submitted on CD, DVD, or flash drive
and mailed to FDA and eSubmissions, submissions created using an
electronic submission template (e.g., ``electronic Submission Template
and Resource'' (eSTAR)). Consistent with our authority in section
745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), and performance goals
found in our current Medical Device User Fee Amendments Commitment
Letter, we developed eSTAR for use through the Center for Devices and
Radiological Health Customer Collaboration Portal. We use eSTAR as a
tool to facilitate the preparation of submissions in electronic format
(available on FDA's website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program and identified as
Form FDA 4062 ``Electronic Submission Template and Resource (eSTAR)''
(for Non-In Vitro Diagnostic submissions) and Form FDA 4078
``Electronic Submission Template and Resource (eSTAR)'' (for In Vitro
Diagnostic submissions)). We believe respondents' use of eSTAR will
significantly reduce burden attendant to application submissions by
providing a uniform format for requisite elements and by enhancing user
interface through the use of modernized technology.
    Finally, we discuss the guidance document entitled ``Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency,'' announced in the Federal Register of March 27, 2023. The
guidance document describes a phased-in approach intended to help avoid
disruption in device supply and help facilitate compliance with
applicable legal requirements. The recommendations discussed in the
guidance document result in the one-time collection of information
intended to ensure an orderly and transparent transition from temporary
policies established during the COVID-19 public health emergency to
normal operations. Because the information collection recommendations
apply to specific medical devices already in distribution, we believe
the information discussed is appropriately characterized as
nonstandardized followup designed to clarify responses to approved
collections of information, i.e., plans for continued compliance unique
to that distributed device. We therefore believe the activity
constitutes the collection of non-identical and/or followup
information, as defined under 5 CFR 1320.3. At the same time, we expect
some degree of fluctuation in future submissions under 21 CFR 814.20,
as a result of implementation of the medical device transition plan.
    In the Federal Register of January 30, 2023 (88 FR 5888), we
published a 60-day notice requesting public comment on the proposed
collection of information.
    We estimate the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
  Activity/21 CFR part/section or FD&C act       Number of     responses per   Total  annual         Average  burden per  response          Total hours
                   section                      respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Premarket Approval Submissions (``traditional'' preparation; eCopy submission):
                                                 21 CFR Part 814, Premarket Approval of Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart A--General:
    Research conducted outside the United                 20               1              20  2.........................................              40
     States (814.15(b)).
Subpart B--Premarket Approval Application
 (PMA):
    PMA application (814.20)................              40               1              40  654.6.....................................          26,184
    Information on clinical investigations                10               1              10  0.5 (30 minutes)..........................               5
     conducted outside the United States
     (814.20(b)(6)(ii)(C)).
    PMA amendments and resubmitted PMAs                1,356               1           1,356  167.......................................         226,452
     (814.37(a)-(c) and (e)).
    PMA supplements (814.39(a)).............             762               1             762  0.5911 (35.5 minutes).....................          45,048
    Special PMA supplement--changes being                 75               1              75  6.........................................             450
     affected (814.39(d)).
    30-day notice (814.39(f))...............           1,181               1           1,181  16........................................          18,896
        Subtotal Parts A and B..............  ..............  ..............  ..............  ..........................................         317,075
Subpart C--FDA Action on a PMA:
    Panel of experts request (814.44 and                   1               1               1  30........................................              30
     515(c)(3) of the FD&C Act).
Subpart E--Postapproval Requirements:
    Postapproval requirements (814.82(a)(9))             121               1             121  135.......................................          16,335
    Periodic reports (814.84(b))............             764               1             764  10........................................           7,640
                                             -----------------------------------------------------------------------------------------------------------
            Total Subpart E.................  ..............  ..............  ..............  ..........................................          24,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
 42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ``Form FDA 3674--Certifications To
                                        Accompany Drug, Biological Product, and Device Applications/Submissions''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification to accompany PMA submissions                40               1              40  0.75 (45 minutes).........................              30
 (Form FDA 3674).
FD&C Act section 515A Pediatric Uses of
 Devices:
    Pediatric information in a PMA, PDP, or              944               1             944  2.10......................................           1,984
     PMA supplement.
    Pediatric use information outside                    800               1             800  0.5 (30 minutes)..........................             400
     approved indication.
                                             -----------------------------------------------------------------------------------------------------------
        Subtotal............................           1,744               1           1,744  ..........................................           2,384
Premarket Approval Submissions (eSTAR
 preparation; eCopy submission):
    eSTAR setup.............................              30               1              30  0.08 (5 minutes)..........................               2
                                             -----------------------------------------------------------------------------------------------------------
        Total...............................  ..............  ..............  ..............  ..........................................         343,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on the annual rate of receipt of PMA
submissions, including PDPs and PMA supplements, for fiscal years 2019
through 2021 and our expectation of submissions to come in the next few
years. We also account for referrals of PMAs to a panel for review, as
provided for under 21 CFR 814.44(a). FDA may refer the PMA to a panel
on its own initiative, and will do so upon request of an applicant,
unless FDA determines that the application substantially duplicates
information previously reviewed by a panel. We have adjusted our
figures to reflect an overall decrease, which we attribute to
respondents' use of modernized submission technologies including eSTAR.
At the same time, we include in our estimate an initial burden
attributable to respondents who need to set up an eSTAR account for the
first time.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per     Total  annual         per          Total  hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (6))......................             552                1              552               17            9,384
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The regulations require the maintenance of records, which are used
to trace patients, and the organization and indexing of records into
identifiable files to ensure a device's continued safety and
effectiveness. These records are required of all applicants who have an
approved PMA. Currently there are 815 active PMAs that could be subject
to these requirements, based on FDA data, and approximately 33 new PMAs
are approved each year. We estimate our annual recordkeeping burden
based on an average of 552 PMA holders. The applicant determines which
records should be maintained during product development to document
and/or substantiate the device's safety and effectiveness. Records
required under 21 CFR part 820 may be relevant to a PMA review and may
be submitted as part of an application. In individual instances,
records may be required as conditions of approval to ensure the
device's continuing safety and effectiveness.

    Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06485 Filed 3-28-23; 8:45 am]
BILLING CODE 4164-01-P