                                  SAMPLE LETTER A: Generic Substantiation, FOIA

  								Approved OMB 2020-0003
                                              Approval expires XXXX

                 Request for Substantiation In Response to a
                 Request Under the Freedom Of Information Act

               By Certified U.S. Mail; Return Receipt Requested
(Name, title, and address of the [designated] representative of the affected business)
Re: Freedom of Information Act (FOIA) Request [INSERT FOIA #]
Dear [Addressee]:
      The U.S. Environmental Protection Agency ("EPA" or "Agency") has received a request under the FOIA for certain records [if submitted by the business whose information it is: that you submitted to the EPA] [if submitted by an entity other than the business whose information it is: in EPA's possession] pertaining to [a detailed description of the information or specific list of documents that is/are the subject of the advance or final confidentiality determination]. [If information has been claimed as CBI: You have claimed (all or part) of this information as confidential business information ("CBI").] [If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has determined that you might be expected to assert a claim that some or all of [if submitted by the business whose information it is: the information you submitted to the EPA] [if submitted by an entity other than the business whose information it is: this information in EPA's possession] is confidential business information ("CBI").] Under the EPA regulations at 40 C.F.R. Part 2, Subpart B, the FOIA request has been initially denied to afford you an opportunity to provide comments to [If no claim has been made: claim this information as CBI and] substantiate your claim(s) as described below.
      The purpose of this letter is to notify you that the EPA (appropriate legal office) will be making a(n) (advance or final) confidentiality determination concerning the information you have claimed as CBI. If you feel that some or all of the information is entitled to confidential treatment, you must make the showings below with specific reference to those portions of the information you consider confidential.
      Please be specific by page (including Bates Stamp, if applicable), paragraph, and sentence when identifying and substantiating the information subject to your claim. Where your claim, as originally made or as modified by your response to this letter, does not include all information on a page, please attach a copy of each such page with brackets around the text that you claim to be CBI. Please note that if a page, document, group, or class of documents claimed by you to be CBI contains a significant amount of information which (appropriate legal office) determines is not CBI, your CBI claim regarding that page, document, group, or class of documents may be denied.  Any information not specifically identified as subject to a confidentiality claim and substantiated as such in your response to this letter may be disclosed to the requester without further notice to you.
      For each item or class of information that you continue to claim as CBI, please answer the following questions, giving as much detail as possible. Your comments in response to these questions will be used by the EPA to determine whether the information has been shown to be entitled to confidential treatment:
      1. 	For what period of time do you request that the information be maintained as confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.
      2. 	Information submitted to the EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question #1?
      3. 	What measures have you taken to protect the information claimed as confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information be considered confidential?
      4. 	Is the information contained in any publicly available material such as the Internet, publicly available databases, promotional publications, annual reports, or articles? If so, specify which.
      5. 	Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?
      6. 	Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.
      7. 	For each item or category of information claimed as confidential, explain with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?
      8. 	Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If you assert that the information is voluntarily submitted information, please explain whether the information is the kind that would customarily not be released to the public.
      9. 	Whether you assert the information as voluntary or involuntary, please address why disclosure of the information would tend to lessen the availability to the EPA of similar information in the future.
      10. 	If you believe any information to be (a) trade secret (s), please so state and explain the reason for your belief. Please attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade secret (s).
      11. 	Explain any other issue you deem relevant (including, if pertinent, reasons why you believe that the information you claim to be CBI is not emission data or effluent data).
      [For contract-related CBI: Enclosed is the EPA Class Determination 1-95 entitled, Confidentiality of Certain Business Information Submitted by Contractors and Prospective Contractors, which addresses the treatment of different types of information related to contracts. You may consider reviewing Class Determination 1-95 as you develop your response.]
      [If applicable to another EPA class determination:  Enclosed is the EPA Class Determination [class determination number] entitled, [name of the class determination], which addresses the treatment of [description of class determination].  You may consider reviewing Class Determination [#] as you develop your response.]
      Please note that you bear the burden of substantiating your confidentiality and trade secret claim(s). Generalized or conclusory statements will be given little or no weight in EPA's determination on the confidentiality of the information you claim to be CBI.
      Your comments must be postmarked or hand delivered to this office, or emailed to [email address], by the 15th working day after your receipt of this letter. You may seek an extension of time to submit your comments to this office, but the request must be made before the end of the 15-day period. Except in extraordinary circumstances, no extension will be approved without the consent of the FOIA requester. Failure to submit your comments within that time will be regarded as a waiver of your confidentiality claim or claims, and the EPA may release the information.
      If you wish to claim any information that you provide in your response to this letter to itself be confidential, you must mark the response "CONFIDENTIAL" or with a similar designation, and must bracket all text in the response that you so claim. Information so designated will be disclosed by the EPA only to the extent allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail to claim the information provided in your response as confidential, it may be made available to the public without further notice to you.
      Should you have any questions concerning this matter, please call me at [telephone number].
                              Sincerely,

                                    [Signature and Title ;   Office Name and Address]
 [Enclosure]

                              SAMPLE LETTER B: Generic Substantiation, Non-FOIA

                                                         Approved OMB 2020-0003
                                                          Approval expires xxxx

             Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]
Re: _________
Dear [Addressee]:
      The U.S. Environmental Protection Agency ("EPA" or "Agency") is seeking to determine the entitlement to confidentiality of [description of the information that is the subject of the advance or final confidentiality determination] [if submitted by the business whose information it is: that you submitted to the EPA] [if submitted by an entity other than the business whose information it is: in EPA's possession.] [If information has been claimed as CBI: You have claimed (all or part) of this information as confidential business information ("CBI").] [If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has determined that you might be expected to assert a claim that some or all of [if submitted by the business whose information it is: the information you submitted to the EPA] [if submitted by an entity other than the business whose information it is: this information in EPA's possession] is confidential business information ("CBI").]
      The purpose of this letter is to notify you that the EPA [appropriate legal office] will be making a(n) [advance or final] confidentiality determination concerning the information you have claimed as CBI. If you feel that some or all of the information is entitled to confidential treatment, you must make the showings below with specific reference to those portions of the information you consider confidential.
      Please be specific by page (including Bates Stamp, if applicable), paragraph, and sentence when identifying and substantiating the information subject to your claim. Where your claim, as originally made or as modified by your response to this letter, does not include all information on a page, please attach a copy of each such page with brackets around the text that you claim to be CBI. Please note that if a page, document, group or class of documents claimed by you to be CBI contains a significant amount of information which our [appropriate legal office] determines is not CBI, your CBI claim regarding that page, document, group, or class of documents may be denied.  Any information not specifically identified as subject to a confidentiality claim and substantiated as such in your response to this letter may be disclosed without further notice to you.
      For each item or class of information that you continue to claim as CBI, please answer the following questions, giving as much detail as possible. Your comments in response to these questions will be used by the EPA to determine whether the information has been shown to be entitled to confidential treatment:
      1. 	For what period of time do you request that the information be maintained as confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.
      2. 	Information submitted to the EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question #1?
      3. 	What measures have you taken to protect the information claimed as confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information be considered confidential?
      4. 	Is the information contained in any publicly available material such as the Internet, publicly available databases, promotional publications, annual reports, or articles? If so, specify which.
      5. 	Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?
      6. 	Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.
      7. 	For each item or category of information claimed as confidential, explain with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?
      8. 	Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If you assert that the information is voluntarily submitted information, please explain whether the information is the kind that would customarily not be released to the public.
      9. 	Whether you assert the information as voluntary or involuntary, please address why disclosure of the information would tend to lessen the availability to the EPA of similar information in the future.
      10. 	If you believe any information to be (a) trade secret(s), please so state and explain the reason for your belief. Please attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade secret(s).
      11. 	Explain any other issue you deem relevant (including, if pertinent, reasons why you believe that the information you claim to be CBI is not emission data or effluent data).
      [For contract-related CBI: Enclosed is the EPA Class Determination 1-95 entitled, Confidentiality of Certain Business Information Submitted by Contractors and Prospective Contractors, which addresses the treatment of different types of information related to contracts. You may consider reviewing Class Determination 1-95 as you develop your response.]
      [If applicable to another EPA class determination:  Enclosed is the EPA Class Determination [class determination number] entitled, [name of the class determination], which addresses the treatment of [description of class determination].  You may consider reviewing Class Determination [#] as you develop your response.]
      Please note that you bear the burden of substantiating your confidentiality and trade secret claim(s). Generalized or conclusory statements will be given little or no weight in EPA's determination on the confidentiality of the information you claim to be CBI.
      Your comments must be postmarked or hand delivered to this office, or emailed to [email address], by the 15th working day after your receipt of this letter. You may seek an extension of time to submit your comments to this office, but the request must be made before the end of the 15-day period. Except in extraordinary circumstances, no extension will be approved. Failure to submit your comments within that time will be regarded as a waiver of your confidentiality claim or claims, and the EPA may release the information.
      If you wish to claim any information that you provide in your response to this letter to itself be confidential, you must mark the response "CONFIDENTIAL" or with a similar designation, and must bracket all text in the response that you so claim. Information so designated will be disclosed by the EPA only to the extent allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail to claim the information provided in your response as confidential, it may be made available to the public without further notice to you.
      Should you have any questions concerning this matter, please call me at [telephone number].
                              Sincerely,
                                    [Signature and Title ;   Office Name and Address]
[Enclosure]
                                                   SAMPLE LETTER C: FIFRA, FOIA

	OMB 2020-0003
	Expires: XXXX
	Inert Ingredients

             Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]

      RE:  Confidential Business Information Determination

Dear [ADDRESSEE]:

      The U.S. Environmental Protection Agency ("EPA") Office of Pesticide Programs has received a request under the FOIA for certain records [if submitted by the business whose information it is: that you submitted to the EPA] [if submitted by an entity other than the business whose information it is: in EPA's possession] pertaining to [a detailed description of the information or specific list of documents that is/are the subject of the advance or final confidentiality determination]. [If information has been claimed as CBI: You have claimed (all or part) of this information as confidential business information ("CBI").] [If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has determined that you might be expected to assert a claim that some or all of [if submitted by the business whose information it is: the information you submitted to the EPA] [if submitted by an entity other than the business whose information it is: this information in EPA's possession] is confidential business information ("CBI").] Under the EPA regulations at 40 C.F.R. Part 2, Subpart B, the FOIA request has been initially denied to afford you an opportunity to provide comments to [If no claim has been made: claim this information as CBI and] substantiate your claim(s) as described below.
      The purpose of this letter is to notify you that the EPA Office of General Counsel will be making a(n) [advance or final] confidentiality determination concerning the information you have claimed as CBI. If you feel that some or all of the information is entitled to confidential treatment, you must make the showings below with specific reference to those portions of the information you consider confidential.

      Please be specific by page (including Bates Stamp, if applicable), paragraph, and sentence when identifying and substantiating the information subject to your claim. Where your claim, as originally made or as modified by your response to this letter, does not include all information on a page, please attach a copy of each such page with brackets around the text that you claim to be CBI. Please note that if a page, document, group, or class of documents claimed by you to be CBI contains a significant amount of information which the Office of General Counsel determines is not CBI, your CBI claim regarding that page, document, group, or class of documents may be denied.  Any information not specifically identified as subject to a confidentiality claim and substantiated as such in your response to this letter may be disclosed to the requester without further notice to you.

  For what period of time do you request that the information be maintained as confidential? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.

 Information submitted to EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question #1?

 What measures have you taken to protect the information claimed as confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information still be considered confidential?

 Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.

 Is the information contained in any publicly available material such as promotional publications, annual reports, articles, etc.? Is there any means by which a member of the public could obtain access to the information?

 For each category of information claimed as confidential, discuss with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?

 Do you assert that the information is "voluntarily submitted" as defined at 40 C.F.R. § 2.201(i)? If so, explain why and how disclosure would tend to lessen EP A's ability to obtain similar information in the future.

 Any other issue you deem relevant.

      Please note that you bear the burden of substantiating your confidentiality and trade secret claim(s) pursuant to 40 CFR § 2.208(e). Generalize or conclusory allegations will be given little or no weight in EPA's determination on the confidentiality of information you claim to be CBI.

      If you wish to claim any information that you provide in your response to this letter to itself be confidential, you must mark the response "CONFIDENTIAL" or with a similar designation, and must bracket all text in the response that you so claim. Information so designated will be disclosed by the EPA only to the extent allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail to claim the information provided in your response as confidential, it may be made available to the public without further notice to you.
Your reply can be mailed to the following address:

Or your reply can be delivered to the following address:

      Your comments must be postmarked or hand-delivered by the 15th working day after your receipt of this letter. If you intend to submit timely comments, please notify by phone at [TELEPHONE NUMBER], by email at or by mail at the address above. Failure to submit timely comments will be regarded as a waiver of your confidentiality claim and EPA will release the information.  You may request an extension of the 15-day deadline. Except in extraordinary circumstances, no extension will be granted without the permission of the requestor.

      Should you have any questions in this matter, please contact [CONTACT NAME].

	Sincerely,

Enclosures

                  SAMPLE LETTER D:  FIFRA; Non-FOIA

	OMB 2020-0003
	Expires

             Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]

      Re: Freedom of Information Act Request [INSERT NUMBER]

Dear [INSERT NAME]:

      The U.S. Environmental Protection Agency ("EPA") Office of Pesticide Programs is seeking to determine the entitlement to confidentiality of [description of the information that is the subject of the advance or final confidentiality determination] [if submitted by the business whose information it is: that you submitted to the EPA] [if submitted by an entity other than the business whose information it is: in EPA's possession.] [If information has been claimed as CBI: You have claimed (all or part) of this information as confidential business information ("CBI").] [If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has determined that you might be expected to assert a claim that some or all of [if submitted by the business whose information it is: the information you submitted to the EPA] [if submitted by an entity other than the business whose information it is: this information in EPA's possession] is confidential business information ("CBI").]
      The purpose of this letter is to notify you that the EPA Office of General Counsel will be making a(n) [advance or final] confidentiality determination concerning the information you have claimed as CBI. If you feel that some or all of the information is entitled to confidential treatment, you must make the showings below with specific reference to those portions of the information you consider confidential.

      Please be specific by page (including Bates Stamp, if applicable), paragraph, and sentence when identifying and substantiating the information subject to your claim. Where your claim, as originally made or as modified by your response to this letter, does not include all information on a page, please attach a copy of each such page with brackets around the text that you claim to be CBI. Please note that if a page, document, group, or class of documents claimed by you to be CBI contains a significant amount of information which the Office of General Counsel determines is not CBI, your CBI claim regarding that page, document, group, or class of documents may be denied.  Any information not specifically identified as subject to a confidentiality claim and substantiated as such in your response to this letter may be disclosed to the requester without further notice to you.

Questions 1-7 must be answered with respect to any confidentiality claims pertaining to the enclosed product chemistry information.

       What value can your competitors derive from knowing the identity, percent by weight, certified limits, or parent process of each impurity? Is this impurity unique to your manufacturing process? Why would your competitors find this impurity preferable over whatever impurity results from their equivalent process?

       Does published analytical methodology exist that could identify and quantify this impurity? If so, why do you believe that your competitors have not already performed such analysis?

       What value can your competitors derive from knowing the description of materials used to produce the product, the description of the production process, or the preliminary production analysis? Why would your competitors find these processes preferable over their equivalent processes?

Questions 4-7 must be answered with respect to any confidentiality claims pertaining to the inert ingredients. Each question must be answered separately with respect to each inert ingredient:

       What is the value that this inert ingredient brings to the product formulation? What characteristics of this ingredient are unique such that competitors might prefer it over whatever ingredients perform the equivalent function in their formulations? Is the use of this ingredient limited to your product, or does it have broader applications?

       Why is it unlikely that your competitors have not already discovered the value of this ingredient? Are you aware of the use of this ingredient as an inert by your competitors?

       To your knowledge, has the use of this inert ingredient in a pesticide been disclosed in a patent? If so, how would disclosure of the identity of the ingredient assist your competitors beyond what is already available through a patent?
       Can the identity of this inert ingredient be determined by product sample analysis? If so, why do you believe that your competitors have not already performed such analysis?

Question 8 must be answered with respect to any confidentiality claims pertaining to the enclosed records:

       For each category of information claimed as confidential, discuss with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?

Questions 9 through 15 must be answered for each type of information that you claimed as confidential:

       For what period of time do you request that the information be maintained as confidential? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.

       Information submitted to EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question number 9?

       What measures have you taken to protect the information? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose it further? If so, why should it still be considered confidential?

       Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.

       Is the presence of this information disclosed in any publicly available material such as Material Safety Data Sheets, promotional publications, annual reports, articles, etc.? Is there any means by which a member of the public could obtain access to the information?

       Do you assert that the information is "voluntarily submitted" as defined at 40 CFR § 2.201(i)? If so, explain why, and how disclosure would tend to lessen EPA's ability to obtain similar information in the future.

       Any other issue you deem relevant.

      Please note that you bear the burden of substantiating your confidentiality and trade secret claim(s) pursuant to 40 CFR § 2.208(e). Generalize or conclusory allegations will be given little or no weight in EPA's determination on the confidentiality of information you claim to be CBI.

      If you wish to claim any information that you provide in your response to this letter to itself be confidential, you must mark the response "CONFIDENTIAL" or with a similar designation, and must bracket all text in the response that you so claim. Information so designated will be disclosed by the EPA only to the extent allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail to claim the information provided in your response as confidential, it may be made available to the public without further notice to you.
      Be advised that information described by Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") section 10(d)(l)(A), (B), and (C) is not automatically entitled to confidential treatment.  Disclosure of such information would only be prohibited, by FIFRA section (b), if the information is eligible for confidential treatment as described by 40 CFR 2.208.

Your reply can be mailed to the following address:

Or your reply can be delivered to my attention at the following address:

      Your comments must be postmarked or hand-delivered by the 15th working day after your receipt of this letter. If you intend to submit timely comments, please notify by phone: [TELEPHONE], by email: [EMAIL ADDRESS], or by mail at the address above.  Failure to submit timely comments will be regarded as a waiver of your confidentiality claim and EPA will release the information.  You may request an extension of the 15-day deadline. Except in extraordinary circumstances, no extension will be granted without the permission of the requester.

      Should you have any questions in this matter, please contact:  [CONTACT PERSON].

                        Sincerely,

					[SIGNATORY AND TITLE]

Enclosures

	SAMPLE LETTER E: TSCA

                                                                  OMB 2020-0003
                                                              Approval expires

By Certified U.S. Mail; Return Receipt Requested

                 MAY CONTAIN CONFIDENTIAL BUSINESS INFORMATION

[Technical Contact Name, title, Company, and Address]

Re: Notice of Review and Request for Substantiation of Confidential Business Information Claim(s)

Document Type:
Document Identifying Number:
Date of Submission:
Type of claim(s) to be reviewed:	 specific chemical identity
					 all other CBI claims

Dear [Addressee]:

Under the Toxic Substance Control Act (TSCA) most confidential business information (CBI) claims for chemical identity and at least 25% of other CBI claims are subject to a review and final determination.  TSCA section 14(g).  15 U.S.C. § 2613(g).

This letter is to notify you that the U.S. Environmental Protection Agency (EPA) Office of General Counsel will be making a final confidentiality determination concerning information you have claimed as CBI, as identified above.  All non-exempt CBI claims must be substantiated.

If you feel that some or all of the information checked above is entitled to confidential treatment, you must substantiate as described below with specific reference to those portions of the information you consider confidential.

Note that TSCA section 14(c)(2) generally exempts certain information types from the requirement to substantiate.  15 U.S.C. § 2613(c)(2).  See EPA webpage [INSERT WEBPAGE] for more guidance on information exempt from substantiation.  To the extent that you believe the information that you have claimed as CBI is one of these exempt information types, you may make this assertion in your response by identifying the specific section 14(c)(2) exemption, in lieu of substantiating the CBI claim for that information.  If the Agency disagrees with this assertion, you may be asked to provide additional information to support your claim.

Substantiating a CBI Claim.

There are two different sets of substantiation questions for CBI claims: (I) questions for all CBI claims in the submission; and (II) questions for chemical identity CBI claims.  Please use the appropriate question set.  In some instances, your TSCA submission may contain both types of CBI claims or a CBI claim may require completing both sets of substantiation questions.  For example, if you assert a CBI claim to protect a chemical substance's identity, then you must answer both question sets.  EPA has identified the appropriate question set(s) via the checkboxes at the top of this letter.  In some instances, for example TSCA section 8(a) Chemical Data Reporting (CDR) Rule submissions, you may have already provided up-front substantiations for some of the CBI claims.  If you have already substantiated your CBI claim at the time of submission, please refer to or preferably physically attach your substantiation to your response to this letter.

Note also that the providing of incorrect information in this substantiation request may be a failure to comply with TSCA, specifically 15 U.S.C. § 2614.

 REQUIRED FOR ALL CBI CLAIMS.

If you are asserting ANY information in the submission as CBI, please answer the following questions.

In supporting your CBI claim(s), please be specific by page, paragraph, sentence, or by data element when identifying and substantiating the information subject to your claim.  Where your claim, as originally made or as modified by your response to this letter, does not include all information on a page, please attach a copy of each such page with brackets around the text that you claim to be CBI.

In some cases, it may be appropriate to group the information into a class of information rather than responding to each item claimed as CBI. See EPA webpage [INSERT WEBPAGE] for suggested approaches to providing substantiations of materials grouped.  For any information that is not specifically identified as subject to a confidentiality claim and substantiated as such in your response to this letter, it shall be determined that you have waived your CBI claim, pursuant to 40 C.F.R. § 2.205(d).

For each item or class of information that you continue to claim as CBI, please answer the following questions, giving as much detail as possible. Your substantiation response to these questions will be used by the EPA to determine whether the information has been shown to be entitled to confidential treatment:

    Do you believe that any of the information claimed as CBI is exempt from substantiation pursuant to TSCA section 14(c)(2)?  Yes/No.

      If you answered yes, please identify the information, provide the specific exemption and answer no further questions related to that information.

      If you answered no, please respond to the questions below.

    Will disclosure of the information likely result in substantial harm to your business competitive position?  Yes/No.

If you answered yes, please describe with specificity the substantial harmful effects that would result to your competitive position if the CBI information is made available to the public.  In your answer, explain the causal relationship between disclosure and any resulting substantial harmful effects. Consider in your answer such constraints as capital and marketing cost, specialized technical expertise, or unusual processes and your competitor's access to your customers.

    To the extent you have disclosed information to others (both internally and externally), what precautions has your business taken?  Please identify any measures or internal controls your business has taken to protect the information claimed as confidential.

 Non-disclosure agreement required prior to access.  Yes/No
 Access is limited to individuals with a need-to-know.  Yes/No
 Information is physically secured (e.g. locked in room or cabinet) or electronically secured (encrypted, password protected, etc.).  Yes/No
 Other internal control measure(s).  If so, please explain.

    Does the information claimed as confidential appear in any public documents, including (but not limited to) safety data sheet, advertising or promotional material, professional or trade publication, or any other media or publications available to the general public?  Yes/No.

      If you answered yes, please explain why the information should nonetheless be treated as confidential.

    Does the information claimed to be CBI contain (a) trade secret(s) ?  Yes/No

If yes, please explain the reason for your belief. Please attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade secret(s).

    If you assert a claim of confidentiality that is less than 10 years (see TSCA section 14(e)(1)(B)), then please indicate the number of years (between 1-10 years) or specific date of which the claim is withdrawn.

    Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this substance? Yes/No.

      If yes, please explain the outcome of that determination and provide EPA with a copy of the previous confidentiality determination or any information that will assist the Agency in identifying the prior determination.

 REQUIRED FOR ONLY CHEMICAL IDENTITY CBI CLAIMS.

If you are claiming a specific chemical identity as CBI, please answer the additional following questions.  If you are not substantiating a chemical identity CBI claim, then you do not need to respond to the questions below.

    Is the chemical substance on the confidential portion of the TSCA Inventory?  Yes/No.

    Commerce:
          Has the chemical substance (or mixture) been offered for commercial distribution?  Yes/No.

          Is the chemical substance known to be in U.S. commerce?  Yes/No.

      If you answered yes, please explain why the information should nonetheless be treated as confidential.

    Disclosure of the specific chemical name would release:

          Confidential process information.  Yes/No.
          Confidential portion of a mixture information.  Yes/No.

      If you answered yes to either question, please explain.

Asserting a CBI claim in your substantiation response.

Businesses may claim their substantiation response as CBI.  Information claimed as confidential should be clearly marked by bracketing, circling, or underlining. All pages containing such information must also be stamped "CONFIDENTIAL BUSINESS INFORMATION" or with similar designation in order to assert a confidentiality claim. Care should be taken to ensure that these markings do not obscure the text.

If you claim your substantiation response as CBI, you must include the following statement in the submission.

      I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
      I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that
             My company has taken reasonable measures to protect the confidentiality of the information;
             I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
             I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
             I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

      Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Timely Responses and Postal Requirements

Your substantiation response must be postmarked or hand delivered to this office by the 15th working day after your receipt of this letter.  While it is anticipated that there will be a means for sending these to the Agency electronically in the future, at this point substantiations should be sent via US Mail or courier.

Filings should be directed to the below address.

      TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

      Courier Deliveries:

U.S. EPA
Office of Pollution Prevention and Toxics
      Confidential Business Information Center (CBIC)
      Attn: TSCA CBI Substantiations
      1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
<PHONE_NUMBER>

You may seek an extension of time to submit your substantiation response to this office, but the request must be made before the end of the 15-day period.  Requests for an extension may be directed to Ms. Quoc Nguyen, Office of General Counsel<EMAIL_ADDRESS>
Failure to timely submit your substantiation response will be regarded as a waiver of your confidentiality claim or claims, and the EPA may release the information.

Should you have any questions concerning this matter, please contact Mr. Scott Sherlock,<PHONE_NUMBER> and<EMAIL_ADDRESS>or Ms. Jessica Barkas,<PHONE_NUMBER> and<EMAIL_ADDRESS>                              Sincerely,

                                    [Signature and Title ;   Office Name and Address]


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73589
Federal Register/Vol. 72, No. 248 /Friday, December 28, 2007 /Rules and Regulations
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We have determined that this AD will
not have federalism implications under
Executive Order 13132. This AD will
not have a substantial direct effect on
the States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
(3) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this AD and placed it in the AD docket.
See the
ADDRESSES
section for a location
to examine the regulatory evaluation.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
ٱ
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
ٱ
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§39.13
[Amended]
ٱ
2. The Federal Aviation
Administration (FAA) amends §39.13
by adding the following new
airworthiness directive (AD):
2007
–26–07 Boeing: Amendment 39–15309.
Docket No. FAA–2007–28352;
Directorate Identifier 2007–NM–037–AD.
Effective Date
(a) This AD becomes effective February 1,
2008.
Affected ADs
(b) None.
Applicability
(c) This AD applies to Boeing Model 747–
200B, 747–300, 747–400, 747–400D, and
747
–400F series airplanes, certificated in any
category, equipped with General Electric
CF6–80C2 engines.
Unsafe Condition
(d) This AD results from two reports of
missing flipper doors for the engine core
cowl. We are issuing this AD to detect and
correct migrated hinge pins and damaged
flipper doors, which could allow the flipper
door to fall off, resulting in the potential for
an engine fire to propagate into the
flammable leakage zone of the strut and for
the amount of fire extinguishing agent
reaching the fire to be diluted, and
subsequent uncontained fire in the engine
strut.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified, unless the
actions have already been done.
Inspection of the Flipper Door Assemblies
(f) Within 24 months after the effective
date of this AD: Do a general visual
inspection for migrated hinge pins and
damaged flipper doors of the left- and right-
hand flipper door assemblies of the engine
core cowls, and do all applicable corrective
actions, by accomplishing all the actions
specified in the Accomplishment
Instructions of Boeing Special Attention
Service Bulletin 747–71–2310, dated October
13, 2005. Do all applicable corrective actions
before further flight. Repeat the inspection
thereafter at intervals not to exceed 18
months for that flipper door assembly, until
doing the actions specified in paragraph (g)
of this AD.
Note 1: Boeing Special Attention Service
Bulletin 747–71–2310, dated October 13,
2005, refers to Rohr Service Bulletin TBC/
80C2–NAC–71–035, dated October 10, 2005,
as an additional source of service information
for accomplishing the actions specified in
paragraph (f) of this AD.
Terminating Action for Repetitive
Inspections
(g) Accomplishing the inspection and
applicable modification of a hinge assembly
of a flipper door assembly of the engine core
cowl in accordance with the
Accomplishment Instructions of Boeing
Special Attention Service Bulletin 747–71–
2310, dated October 13, 2005; or Rohr
Service Bulletin TBC/80C2–NAC–71–035,
dated October 10, 2005; terminates the
repetitive inspection requirements of this AD
for that hinge assembly.
Parts Installation
(h) As of the effective date of this AD, no
person may install, on any airplane, a hinge
assembly, part number 224–2335–69, for the
flipper door of the engine core cowl unless
it has been modified in accordance with the
requirements of paragraph (g) of this AD.
Material Incorporated by Reference
(i) You must use Boeing Special Attention
Service Bulletin 747–71–2310, dated October
13, 2005, to perform the actions that are
required by this AD, unless the AD specifies
otherwise. The Director of the Federal
Register approved the incorporation by
reference of this document in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
Contact Boeing Commercial Airplanes, P.O.
Box 3707, Seattle, Washington 98124–2207,
for a copy of this service information. You
may review copies at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW.,
Renton, Washington; or at the National
Archives and Records Administration
(NARA). For information on the availability
of this material at NARA, call 202–741–6030,
or go to:
http://www.archives.gov/federal-
register/cfr/ibr-locations.html.
Issued in Renton, Washington, on
December 11, 2007.
Michael J. Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E7–24520 Filed 12–27–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 772
Definitions of Terms
CFR Correction
In Title 15 of the Code of Federal
Regulations, Parts 300 to 799, revised as
of January 1, 2007, on page 577, in
§772.1, in the second column, the
second definition of
Production
is
removed.
[FR Doc. 07–55526 Filed 12–27–07; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 312, 314, 601, 610,
801, 807, 809, 812, and 814
[Docket No. 2006N–0466]
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Interim final rule; request for
comments.
SUMMARY:
The Food and Drug
Administration (FDA) is issuing
regulations to permit FDA Center
Directors to grant exceptions or
alternatives to certain regulatory
labeling requirements applicable to
human drugs, biological products, or
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73590
Federal Register/Vol. 72, No. 248 /Friday, December 28, 2007 /Rules and Regulations
medical devices that are or will be
included in the Strategic National
Stockpile (SNS). Under this rule, the
appropriate FDA Center Director may
grant an exception or alternative to such
labeling requirements if he or she
determines that compliance with the
requirements could adversely affect the
safety, effectiveness, or availability of
specified lots, batches, or other units of
human drugs, biological products, or
medical devices that are or will be
included in the SNS, including not only
those that are approved, licensed, or
cleared for marketing, but also those
that are investigational. A grant of an
exception or alternative under these
regulations will include any safeguards
or conditions deemed appropriate by
the FDA Center Director to ensure that
the labeling of such products includes
information for the safe and effective
use of the products given their
anticipated circumstances of use. This
rule will facilitate the safety,
effectiveness, and availability of
appropriate medical countermeasures in
the event of a public health emergency.
DATES:
The interim final rule is effective
on December 28, 2007. Submit written
or electronic comments on the interim
final rule by March 27, 2008. Submit
written or electronic comments
regarding the information collection by
January 28, 2008 to the Office of
Management and Budget (OMB) (see
ADDRESSES
).
ADDRESSES:
You may submit comments,
identified by Docket No. 2006N–0466,
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
•
Federal eRulemaking Portal:
http://
www.regulations.gov
. Follow the
instructions for submitting comments.
•
Agency Web site:
http://
www.fda.gov/dockets/ecomments
.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
•
FAX: 301–827–6870.
•
Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by e-
mail. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described in the
Electronic Submissions
portion of this
paragraph.
Instructions
: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received may be posted
without change to
http://www.fda.gov/
ohrms/dockets/default.htm
, including
any personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION
section of
this document.
Docket
: For access to the docket to
read background documents or
comments received, go to
http://
www.fda.gov/ohrms/dockets/
default.htm
and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Information Collection Provisions
:
Submit written comments on the
information collection provisions to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget (OMB). To ensure that
comments on the information collection
are received, OMB recommends that
written comments be faxed to the Office
of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202
–395–6974.
FOR FURTHER INFORMATION CONTACT:
For
information concerning human
biological products
: Stephen Ripley,
Center for Biologics Evaluation and
Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301
–827–6210.
For information concerning human
drug products
: Brad G. Leissa, Center for
Drug Evaluation and Research, Food
and Drug Administration, Mail Stop
1603, 10903 New Hampshire Ave.,
White Oak Complex, Building 21, Room
1624, Silver Spring, MD 20993, 301–
796
–2190.
For information concerning medical
devices
: Casper E. Uldriks, Center for
Devices and Radiological Health, Food
and Drug Administration, 2094 Gaither
Rd., rm. 229, Rockville, MD 20850, 301–
276
–0106.
SUPPLEMENTARY INFORMATION:
I. Introduction
This interim final rule applies to
human drugs, biological products, and
medical devices (hereinafter referred to
collectively as medical products) that
are or will be held in the SNS, including
those SNS assets that are held at the
manufacturer’s facility or elsewhere on
behalf of the SNS (e.g., vendor managed
inventory that is distributed, held, and
managed by manufacturers or
commercial distributors for the SNS)
and prepositioned locations (e.g.,
CHEMPACKs that are distributed, held,
and managed by hospitals and other
facilities for the SNS).
An act of terrorism or a natural
disaster event may result in the need for
rapid access to large quantities of
medical products. Under the Public
Health Service Act (PHS Act), the
Department of Health and Human
Services (HHS) stockpiles medical
products that are essential to the health
security of the Nation. (See PHS Act
section 319F–2, 42 U.S.C. 247d–6b)).
This collection of medical products ,
known as the SNS, is to ‘‘provide for the
emergency health security of the United
States, including the emergency health
security of children and other
vulnerable populations, in the event of
a bioterrorist attack or other public
health emergency.’’ The SNS is
maintained by the Assistant Secretary
for Preparedness and Response (ASPR),
exercising this responsibility and
authority of the Secretary, in
collaboration with the Director of the
Centers for Disease Control and
Prevention (CDC), and in coordination
with the Department of Homeland
Security. Examples of situations that
may necessitate the deployment of such
products from the SNS are:
•
Acts of terrorism using chemical,
biological, radiological, or nuclear
agents;
•
Mass trauma; or
•
Natural disasters such as
hurricanes, pandemics, or earthquakes.
The SNS is also designed to augment
similar stockpiles of medical supplies
held by State and local public health
agencies for use in the event of a
national emergency.
II. Background
It may be appropriate for certain
medical products that are or will be
held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations, given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (the FFD&C Act or the
act) (21 U.S.C. 352).
Under this rule, the appropriate FDA
Center Director may grant an exception
or alternative to certain FDA labeling
requirements if compliance with the
requirements could adversely affect the
safety, effectiveness, or availability of
products that are or will be in the SNS.
An exception or alternative granted
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73591
Federal Register/Vol. 72, No. 248 /Friday, December 28, 2007 /Rules and Regulations
1
Medical products stockpiled in the SNS may
also include products that will ultimately be used
in an emergency under section 564 of the FFD&C
act (21 U.S.C. 360bbb-3) (regarding Emergency Use
Authorizations).
under this rule may include conditions
or safeguards so that the labeling for
such products includes appropriate
information necessary for the safe and
effective use of the product given the
product’s anticipated circumstances of
use.
Issues relating to the labeling of
products that are or will be in the SNS
exist now and will likely continue to
develop. Such labeling issues may arise
as a result of many different factors,
including the indicated use, the storage
location, the necessary storage
conditions for a particular product, or
the unique distribution mechanisms
that may be used in an emergency. The
provisions of this rule apply only to
medical products that are or will be
included in the SNS.
The medical products that may be
stockpiled in the SNS include not only
those that are approved, licensed, or
cleared for marketing, but also those
that are investigational. When HHS
1
procures investigational medical
products for the SNS (i.e., products for
which investigational new drug (IND)
applications or investigational device
exemptions (IDE) are in effect), it
anticipates that these products may
eventually become licensed, approved,
or cleared for marketing by FDA while
the products remain stockpiled. Labels
on investigational products, however,
including those in the SNS, ordinarily


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Rules and Regulations]
[Pages 59484-59486]
[FR Doc No: 2016-20856]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0832]
RIN 1625-AA00

Safety Zone; Caribbean Fantasy, Vessel on Fire; Punta Salinas,
Toa Baja, Puerto Rico

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone of
1,000 yards radius for the Cruise Ship Caribbean Fantasy due to an
imminent fire on board, in the vicinity of Punta Salinas, Toa Baja,
Puerto Rico. The safety zone is needed to protect personnel, vessels,
and the marine environment from potential hazards associated with the
fire on board the vessel. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
San Juan.

DATES: This rule is effective without actual notice from August 30,
2016 until 11:59 p.m. on August 31, 2016. For purposes of enforcement,
actual notice will be used from 3 p.m. on August 17, 2016 through
August 30, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0832 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Efrain Lopez, Sector San Juan

Prevention Department, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because of the immediate actions needed to
respond to the emergency and potential safety hazards associated with
the fire on board the Caribbean Fantasy. It is impracticable to publish
an NPRM because we must establish this safety zone immediately, on
August 17, 2016.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making it effective less than 30
days after publication in the Federal Register. Delaying the effective
date of this rule would be contrary to public interest because
immediate action is needed to respond to the emergency and potential
safety hazards associated with the fire on board the Caribbean Fantasy.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port San Juan (COTP) has determined that
potential hazards associated with fire will be a safety concern for
anyone within a 1000-yard radius the Caribbean Fantasy. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone.

IV. Discussion of the Rule

    This rule establishes a safety zone from 3 p.m. on August 17, 2016
until 11:59 p.m. on August 31, 2016. The safety zone will cover all
navigable waters within 1000 yards of the vessel Caribbean Fantasy. The
duration of the zone is intended to protect personnel, vessels, and the
marine environment in these navigable waters while the passenger gets
rescued and the fire gets suppressed. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    The safety zone listed in this rule will restrict vessel traffic
from entering, transiting in or operating on the waters within this
zone. The effect of this regulation will not be significant for several
reasons: (1) this rule will only affect vessel traffic for a short
duration; (2) vessels may request permission from the COTP to transit
through the safety zone; and (3) the impacts on routine navigation are
expected to be minimal. Notifications to the marine community will be
made through Broadcast Notice to Mariners via VHF-FM marine channel 16
and on-scene representatives. These notifications will allow the public
to plan operations around the affected areas.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes,

or on the distribution of power and responsibilities between the
Federal Government and Indian tribes. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone that will prohibit entry within 1000 yards
of the Caribbean Fantasy due to an imminent fire on board. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

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2. Add a temporary Sec.  165.T07-0832 to read as follows:

Sec.  165.T07-0832  Safety Zone; Caribbean Fantasy, Vessel on Fire;
Punta Salinas, Toa Baja, Puerto Rico.

    (a) Regulated area. The following area is a safety zone: all waters
within 1,000 yard radius from the Caribbean Fantasy, located in Punta
Salinas, Toa Baja, Puerto Rico.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Jacksonville in the enforcement of the regulated
area.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this safety zone is prohibited unless
specifically authorized by the Captain of the Port San Juan or a
designated representative.
    (2) Persons or vessels desiring enter into, pass through, or
operate on the waters within this zone, must request permission from
the Captain of the Port San Juan or a designated representative. They
may be contacted on VHF-FM Channel 16 or by telephone at (787) 289-
2041.
    (3) If permission is granted, all persons and vessels shall comply
with any specific instructions of the Captain of the Port San Juan or
designated representative, while transiting through the zone.
    (d) Informational broadcasts. The Coast Guard will provide notice
of the regulated area by Broadcast Notices to Mariners and on-scene
designated representatives.
    (e) Enforcement period. This safety zone will be enforced from 3
p.m. on August 17, 2016 through 11:59 p.m. on August 31, 2016.

    Dated: August 17, 2016.
R.W. Warren,
Captain, U.S. Coast Guard, Captain of the Port San Juan.
[FR Doc. 2016-20856 Filed 8-29-16; 8:45 am]
 BILLING CODE 9110-04-P