Code of Federal Regulations: Section 203
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Title 37: Patents, Trademarks, and Copyrights
§202.1 Material not subject to copyright.
The following are examples of works not subject to copyright and applications for registration of such works cannot be entertained:
(a) Words and short phrases such as names, titles, and slogans; familiar symbols or designs; mere variations of typographic ornamentation, lettering or coloring; mere listing of ingredients or contents;
(b) Ideas, plans, methods, systems, or devices, as distinguished from the particular manner in which they are expressed or described in a writing;
(c) Blank forms, such as time cards, graph paper, account books, diaries, bank checks, scorecards, address books, report forms, order forms and the like, which are designed for recording information and do not in themselves convey information;
(d) Works consisting entirely of information that is common property containing no original authorship, such as, for example: Standard calendars, height and weight charts, tape measures and rulers, schedules of sporting events, and lists or tables taken from public documents or other common sources.
(e) Typeface as typeface.
[24 FR 4956, June 18, 1959, as amended at 38 FR 3045, Feb. 1, 1973; 57 FR 6202, Feb. 21, 1992]
§202.2 Copyright notice.
(a) General. (1) With respect to a work published before January 1, 1978, copyright was secured, or the right to secure it was lost, except for works seeking ad interim copyright, at the date of publication, i.e., the date on which copies are first placed on sale, sold, or publicly distributed, depending upon the adequacy of the notice of copyright on the work at that time. The adequacy of the copyright notice for such a work is determined by the copyright statute as it existed on the date of first publication.
(2) If before January 1, 1978, publication occurred by distribution of copies or in some other manner, without the statutory notice or with an inadequate notice, as determined by the copyright statute as it existed on the date of first publication, the right to secure copyright was lost. In such cases, copyright cannot be secured by adding the notice to copies distributed at a later date.
(3) Works first published abroad before January 1, 1978, other than works for which ad interim copyright has been obtained, must have borne an adequate copyright notice. The adequacy of the copyright notice for such works is determined by the copyright statute as it existed on the date of first publication abroad.
(b) Defects in notice. Where the copyright notice on a work published before January 1, 1978, does not meet the requirements of title 17 of the United States Code as it existed on December 31, 1977, the Copyright Office will reject an application for copyright registration. Common defects in the notice include, among others the following:
(1) The notice lacks one or more of the necessary elements (i.e., the word “Copyright,” the abbreviation “Copr.”, or the symbol ©, or, in the case of a sound recording, the symbol ©; the name of the copyright proprietor, or, in the case of a sound recording, the name, a recognizable abbreviation of the name, or a generally known alternative designation, of the copyright owner; and, when required, the year date of publication);
(2) The elements of the notice are so dispersed that a necessary element is not identified as a part of the notice; in the case of a sound recording, however, if the producer is named on the label or container, and if no other name appears in conjunction with the notice, his name will be considered a part of the notice;
(3) The notice is not in one of the positions prescribed by law;
(4) The notice is in a foreign language;
(5) The name in the notice is that of someone who had no authority to secure copyright in his name;
(6) The year date in the copyright notice is later than the date of the year in which copyright was actually secured, including the following cases:
(i) Where the year date in the notice is later than the date of actual publication;
(ii) Where copyright was first secured by registration of a work in unpublished form, and copies of the same work as later published without change in substance bear a copyright notice containing a year date later than the year of unpublished registration;
(iii) Where a book or periodical published abroad, for which ad interim copyright has been obtained, is later published in the United States without change in substance and contains a year date in the copyright notice later than the year of first publication abroad:
Provided, however, That in each of the three foregoing types of cases, if the copyright was actually secured not more than one year earlier than the year date in the notice, registration may be considered as a doubtful case.
[24 FR 4956, June 18, 1959; 24 FR 6163, July 31, 1959, as amended at 37 FR 3055, Feb. 11, 1972; 46 FR 33249, June 29, 1981; 46 FR 34329, July 1, 1981; 60 FR 34168, June 30, 1995; 66 FR 34373, June 28, 2001; 66 FR 40322, Aug. 2, 2001; 77 FR 18707, Mar. 28, 20120; 77 FR 20988, Apr. 9, 2012]
§202.3 Registration of copyright.
(a) General. (1) This section prescribes conditions for the registration of copyright, and the application to be made for registration under sections 408 and 409 of title 17 of the United States Code, as amended by Pub. L. 94-553.
(2) For the purposes of this section, the terms audiovisual work, compilation, copy, derivative work, device, fixation, literary work, motion picture, phonorecord, pictorial, graphic and sculptural works, process, sound recording, and their variant forms, have the meanings set forth in section 101 of title 17. The term author includes an employer or other person for whom a work is “made for hire” under section 101 of title 17.
(3) For the purposes of this section, a copyright claimant is either:
(i) The author of a work;
(ii) A person or organization that has obtained ownership of all rights under the copyright initially belonging to the author.1
1This category includes a person or organization that has obtained, from the author or from an entity that has obtained ownership of all rights under the copyright initially belonging to the author, the contractual right to claim legal title to the copyright in an application for copyright registration.
(b) Administrative classification and application forms—(1) Classes of works. For the purpose of registration, the Register of Copyrights has prescribed the classes of works in which copyright may be claimed. These classes, and examples of works which they include, are as follows:
(i) Class TX: Nondramatic literary works. This class includes all published and unpublished nondramatic literary works. Examples: Fiction; nonfiction; poetry; textbooks; reference works; directories; catalogs; advertising copy; and compilations of information.
(ii) Class PA: Works of the performing arts. This class includes all published and unpublished works prepared for the purpose of being performed directly before an audience or indirectly by means of a device or process. Examples: Musical works, including any accompanying words; dramatic works, including any accompanying music; pantomimes and choreographic works; and motion pictures and other audiovisual works.
(iii) Class VA: Works of the visual arts. This class includes all published and unpublished pictorial, graphic, and sculptural works. Examples: Two dimensional and three dimensional works of the fine, graphic, and applied arts; photographs; prints and art reproductions; maps, globes, and charts; technical drawings, diagrams, and models; and pictorial or graphic labels and advertisements.
(iv) Class SR: Sound recordings. This class includes all published and unpublished sound recordings fixed on and after February 15, 1972. Claims to copyright in literary, dramatic, and musical works embodied in phonorecords may also be registered in this class under paragraph (b)(4) of this section if:
(A) Registration is sought on the same application for both a recorded literary, dramatic, or musical work and a sound recording;
(B) The recorded literary, dramatic, or musical work and the sound recording are embodied in the same phonorecord; and
(C) The same claimant is seeking registration of both the recorded literary, dramatic, or musical work and the sound recording.
(v) Class SE: Serials. A serial is a work issued or intended to be issued in successive parts bearing numerical or chronological designations and intended to be continued indefinitely. This class includes periodicals; newspapers; annuals; and the journals, proceedings, transactions, etc. of societies.
(2) Submission of application for registration. For purposes of registration, an applicant may submit an application for registration of individual works and certain groups of works electronically through the Copyright Office's Web site, or by using the printed forms prescribed by the Register of Copyrights.
(i) Electronic applications. (A) An applicant may submit an application electronically through the Copyright Office Web site [www.copyright.gov] For non-group registrations, an applicant may submit a standard electronic application, or an applicant may submit a “single” application.
(B) A “single” application can be made only for a single work by a single author that is owned by the person who created it, and is not a work made for hire. The claimant and the author must be the same. A third party may remit a “single” application on behalf of the author/claimant, provided that party lists itself as the correspondent. The following categories of work may not be registered using the “single” application: collective works, unpublished collections, units of publication, group registration options, databases, Web sites, works by more than one author, and works with more than one owner. The designation of a work as eligible for a “single” registration does not include work characterized as a “single work” under paragraph (b)(4) of this section.
(C) An online submission requires a payment of the application fee through an electronic fund transfer, credit or debit card, or through a Copyright Office deposit account.
(D) Deposit materials in support of an online application may be submitted electronically in a digital format (if eligible) along with the application and payment, or a remitter may send physical copies or phonorecords as necessary to satisfy the best edition requirements, by mail to the Copyright Office, using the required shipping slip generated during the online registration process.
(ii) (A) Alternatively, an applicant may submit an application on one of the printed forms prescribed by the Register of Copyrights. Each printed form corresponds to a class set forth in paragraph (b)(1) of this section and is so designated (“Form TX”; “Short Form TX”, “Form PA”; “Short Form PA”, “Form VA”; “Short Form VA”, “Form SR”; “Form SE”; “Short Form SE”, and “Form SE/Group”).
(B) Short form applications may only be used if certain conditions are met. Short Form TX, Short Form PA, and Short Form VA may be used only to register a single work in a case when a living author who is the only author of his or her work is the sole owner of the copyright in the work, the work is not a compilation or derivative work containing a substantial amount of previously published or registered material, and the work is not a work made for hire. Short Form SE may be used only if the claim is in a collective work, the work is essentially an all-new collective work or issue, the author is a citizen or domiciliary of the United States, the work is a work for hire, the author(s) and claimant(s) are the same person(s) or organization(s), and the work was first published in the United States.
(C) Printed form applications should be submitted in the class most appropriate to the nature of the authorship in which copyright is claimed. In the case of contributions to collective works, applications should be submitted in the class representing the copyrightable authorship in the contribution. In the case of derivative works, applications should be submitted in the class most appropriately representing the copyrightable authorship involved in recasting, transforming, adapting, or otherwise modifying the preexisting work. In cases where a work contains elements of authorship in which copyright is claimed which fall into two or more classes, the application should be submitted in the class most appropriate to the type of authorship that predominates in the work as a whole. However, in any case where registration is sought for a work consisting of or including a sound recording in which copyright is claimed, the application shall be submitted on Form SR.
(D) Copies of the printed forms are available on the Copyright Office's Web site [www.copyright.gov] and upon request to the Copyright Public Information Office, Library of Congress. Printed form applications may be completed and submitted by completing a printed version or using a PDF version of the applicable Copyright Office application form and mailing it together with the other required elements, i.e., physically tangible deposit copies and/or materials, and the required filing fee, all elements being placed in the same package and sent by mail or hand-delivered to the Copyright Office.
(3) Continuation sheets. A continuation sheet (Form CON) is appropriate only in the case when a printed form application is used and where additional space is needed by the applicant to provide all relevant information concerning a claim to copyright. An application may include more than one continuation sheet, subject to the limitations in paragraph (b)(10)(v) of this section.
(4) Registration as a single work. (i) For the purpose of registration on a single application and upon payment of a single registration fee, the following shall be considered a single work:
(A) In the case of published works: all copyrightable elements that are otherwise recognizable as self-contained works, that are included in a single unit of publication, and in which the copyright claimant is the same; and
(B) In the case of unpublished works: all copyrightable elements that are otherwise recognizable as self-contained works, and are combined in a single unpublished “collection.” For these purposes, a combination of such elements shall be considered a “collection” if:
(1) The elements are assembled in an orderly form;
(2) The combined elements bear a single title identifying the collection as a whole;
(3) The copyright claimant in all of the elements, and in the collection as a whole, is the same; and
(4) All of the elements are by the same author, or, if they are by different authors, at least one of the authors has contributed copyrightable authorship to each element.
Registration of an unpublished “collection” extends to each copyrightable element in the collection and to the authorship, if any, involved in selecting and assembling the collection.
2This does not require that each of the works must have been first published during the same calendar year; it does require that, to be grouped in a single application, the earliest and latest contributions must not have been first published more than twelve months apart.
(D) Each of the works, if first published before March 1, 1989, bore a separate copyright notice, and the name of the owner of copyright in each work (or an abbreviation by which the name can be recognized, or a generally known alternative designation of the owner) was the same in each notice; and
(E) The deposit accompanying the application must consist of one of the following: one copy of the entire issue of the periodical, or, in the case of a newspaper, the entire section containing the contribution; tear sheets or proof copies of the contribution; a photocopy of the contribution itself, or a photocopy of the entire page containing the contribution; the entire page containing the contribution cut or torn from the collective work; the contribution cut or torn from the collective work; or photographs or photographic slides of the contribution or entire page containing the contribution as long as all contents of the contribution to be registered are clear and legible.
(ii) An application for group registration under section 408(c)(2) of title 17 and paragraph (b)(8) of this section shall consist of:
(A) A basic application for registration on Form TX, Form PA, or Form VA,3 which shall contain the information required by the form and its accompanying instructions;
3The basic application should be filed in the class appropriate to the nature of authorship in the majority of the contributions. However, if any of the contributions consists preponderantly of nondramatic literary material that is in the English language, the basic application for the entire group should be submitted on Form TX.
(B) An adjunct form prescribed by the Copyright Office and designated “Adjunct Application for Copyright Registration for a Group of Contributions to Periodicals (Form GR/CP)”, which shall contain the information required by the form and its accompanying instructions; and
(C) The appropriate filing fee, as required in §201.3(c), and the deposit required by paragraph (b)(8)(i)(E) of this section.
(9) Group registration of daily newsletters. Pursuant to the authority granted by 17 U.S.C. 408(c)(1), the Register of Copyrights has determined that, on the basis of a single application, deposit, and filing fee, a single registration may be made for a group of two or more issues of a daily newsletter if the following conditions are met:
(i) As used in this regulation, daily newsletter means a serial published and distributed by mail or electronic media (online or telefacsimile), or in any medium including but not limited to, paper, cassette tape, diskette or CD-ROM. Publication must occur on at least two days each week and the newsletter must contain news or information of interest chiefly to a special group (for example, trade and professional associations, corporate in-house groups, schools, colleges, or churches).
(ii) The works must be essentially all new collective works or all new issues that have not been published before.
(iii) Each issue must be a work made for hire.
(iv) The author(s) and claimant(s) must be the same person(s) or organization(s) for all of the issues.
(v) All the items in the group must bear issue dates within a single calendar month under the same continuing title.
(vi) Deposit. (A). The deposit for newsletters registered under this section is one complete copy of each issue included in the group.
(B). In addition, if requested in writing by the Copyright Acquisitions Division before an application for registration is submitted, the claimant must give the Library of Congress whichever of the following the Library prefers: either as many as two complimentary subscriptions of the newsletter in the edition most suitable to the Library's needs, or a single positive, 35 mm silver halide microfilm meeting the Library's best edition criteria that includes all issues published as final editions in the designated calendar month. Subscription copies must be delivered to the separate address specified by the Copyright Acquisitions Division in its request. Subscription copies or a microfilm are not required unless expressly requested by the Copyright Acquisitions Division.
(C) The copyright owner of any newsletter that cannot meet the criteria set out in this section may continue to register on Form SE or Short Form SE.
(vii) Registration is sought within three months after the publication date of the last issue included in the group.
(viii) A Form G/DN shall be submitted for daily newsletters bearing issue dates within a single month, together with one copy of each issue, and a filing fee. The application shall designate the first and last day that issues in the group were published.
(10) Group registration of published photographs. Pursuant to the authority granted by 17 U.S.C. 408(c)(1), the Register of Copyrights will accept a single application (on Form VA), deposit and filing fee for registration of a group of photographs if the following conditions are met:
(i) The copyright claimant in all of the photographs must be the same.
(ii) The photographer who photographed each of the photographs submitted for registration as part of the group must be the same person.
(iii) The photographs in the group must have been published within the same calendar year.
(iv) If the photographs in a group were all published on the same date, the date of publication must be identified in space 3b of the application. If the photographs in a group were not all published on the same date, the range of dates of publication (e.g., February 15-September 15, 2004) must be provided in space 3b of the application, and the date of publication of each photograph within the group must be identified either:
(A) On each deposited image;
(B) In a text file on the CD-ROM or DVD that contains the deposited photographic images;
(C) On a list that accompanies the deposit and provides the publication date for each image; or
(D) On a special continuation sheet (Form GR/PPh/CON) provided by the Copyright Office. Dates of publication must be provided in a way that clearly identifies the date of publication for each individual photograph in the group.
(v) If the applicant chooses to identify the date of publication for each photograph in the group on a continuation sheet, the application may include no more than 50 continuation sheets identifying no more than 750 photographs. For these purposes, the applicant must use the special continuation sheet (Form GR/PPh/CON) for registration of a group of photographs made available by the Copyright Office.
(vi) If each photograph within the group was first published within three months before the date on which an acceptable application, an acceptable deposit, and the applicable fee are received in the Copyright Office, the applicant may, in lieu of the procedure set forth in paragraph (b)(10)(iv) of this section, simply state the range of dates of publication (e.g., February 15-May 15, 2001) in space 3b of the application, without specifically identifying the date of publication of each photograph in the group either on the deposited image or on a continuation sheet.
(vii) The deposit(s) and application must be accompanied by the fee set forth in §201.3(c) of this chapter for a basic registration.
(viii) The applicant must state “Group Registration/Photos” and state the approximate number of photographs included in the group in space 1 of the application Form VA under the heading “Previous or Alternative Titles” (e.g., “Group Registration/Photos; app. 450 photographs”).
(ix) If the photographs in the group are works made for hire, the applicant must note, as part of the applicant's entry in space 2 of the application Form VA for “Name of Author,” both the name of the employer for hire and the name of the photographer who photographed the works in the group (e.g., “XYZ Corporation, employer for hire of John Doe”).
(x) As an alternative to the best edition of the work, one copy of each photograph shall be submitted in one of the formats set forth in §202.20(c)(2)(xx).
(xi) Instead of using Form VA, an applicant may submit an electronic application for group registration of published photographs after consultation and with the permission and under the direction of the Visual Arts Division.
(11) One registration per work. As a general rule only one copyright registration can be made for the same version of a particular work. However:
(i) Where a work has been registered as unpublished, another registration may be made for the first published edition of the work, even if it does not represent a new version;
(ii) Where someone other than the author is identified as copyright claimant in a registration, another registration for the same version may be made by the author in his or her own name as copyright claimant;4
4An author includes an employer or other person for whom a work is “made for hire” under 17 U.S.C. 101. This paragraph does not permit an employee or other person working “for hire” under that section to make a later registration in his or her own name. In the case of authors of a joint work, this paragraph does permit a later registration by one author in his or her own name as copyright claimant, where an earlier registration identifies only another author as claimant.
(iii) Where an applicant for registration alleges that an earlier registration for the same version is unauthorized and legally invalid, a registration may be made by that applicant; and
(iv) Supplementary registrations may be made, under the conditions of §201.5 of these regulations, to correct or amplify the information in a registration made under this section.
(c) Application for registration. (1) An application for copyright registration may be submitted by any author or other copyright claimant of a work, or the owner of any exclusive right in a work, or the duly authorized agent of any such author, other claimant, or owner.
(2) An application for copyright registration shall be submitted by using one of the methods set forth in paragraph (b) of this section. All completed application forms shall be accompanied by the appropriate filing fee, as required in §201.3(c) of this chapter, and the deposit copies and materials required under 17 U.S.C. 408 and §202.20.6 All applications submitted for registration shall supply the information required by the particular application and shall include a certification. The certification shall consist of:
(i) A designation that the party signing the print application, or submitting the application electronically, falls within an accepted status from among the following: author, claimant, an owner of exclusive rights, or a duly authorized agent of the author, claimant, owner of exclusive rights;
(ii) For print applications, the handwritten signature of the party described in paragraph (c)(2)(i) of this section accompanied by the typed or printed name of that party; or, if an electronically submitted application, a name provided within the certification screen of the electronic application which represents a party described in paragraph (c)(2)(i) of this section;
(iii) A declaration that information provided within the application is correct to the best of that party's knowledge; and,
(iv) For print applications, the date of completion of the application form, with the date (month, day, year) printed, typed, or handwritten; or, if an electronically submitted application, the date of electronic receipt of the application by the Copyright Office, which date shall be provided automatically by the Copyright Office.
5In the case of applications for group registration of newspapers, contributions to periodicals, and newsletters, under paragraphs (b)(7), (b)(8), and (b)(9) of this section, the deposits shall comply with the deposits specified in the respective paragraphs, and the fees with those specified in §201.3.
An application for registration of a published work will not be accepted if the date of certification is earlier than the date of publication given in the application.
(Pub. L. 94-553; secs. 408, 409, 410, 702)
[43 FR 966, Jan. 5, 1978]
Editorial Note: For Federal Register citations affecting §202.3, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
§202.4 Effective date of registration.
The effective date of registration for claims received in the Copyright Office on or after January 3, 1991, and through December 31, 1991, with a short fee of $10 is the date on which the application, deposit, and $10 fee have all been received in the Copyright Office, provided, the claim is later determined to be acceptable for registration by the Register of Copyrights and a supplementary fee of $10 is received in the Copyright Office. If the supplementary fee is not received promptly after notification of the short fee, the Copyright Office will initiate a proceeding to cancel the copyright registration. If the supplementary fee of $10 is not received in the Copyright Office before the cancellation proceeding is completed, the cancellation will become final and will result in the loss of the effective date of registration. After cancellation, registration could be obtained only by submitting a new application, deposit, and filing fee.
[55 FR 50001, Dec. 4, 1990]
§202.5 Reconsideration Procedure for Refusals to Register.
(a) General. This section prescribes rules pertaining to procedures for administrative review of the Copyright Office's refusal to register a claim to copyright, a mask work, or a vessel hull design upon a finding by the Office that the application for registration does not satisfy the legal requirements of title 17 of the United States Code. If an applicant's initial claim is refused, the applicant is entitled to request that the initial refusal to register be reconsidered.
(b) First reconsideration. Upon receiving a written notification from the Registration Program explaining the reasons for a refusal to register, an applicant may request that the Registration Program reconsider its initial decision to refuse registration, subject to the following requirements:
(1) An applicant must request in writing that the Registration Program reconsider its decision. A request for reconsideration must include the reasons the applicant believes registration was improperly refused, including any legal arguments in support of those reasons and any supplementary information. The Registration Program will base its decision on the applicant's written submissions.
(2) The fee set forth in §201.3(d)(3)(i) of this chapter must accompany the first request for reconsideration.
(3) The first request for reconsideration and the applicable fee must be received by the Copyright Office no later than three months from the date that appears in the Registration Program written notice of its initial decision to refuse registration. When the ending date for the three-month time period falls on a weekend or a Federal holiday, the ending day of the three-month period shall be extended to the next Federal work day.
(4) If the Registration Program decides to register an applicant's work in response to the first request for reconsideration, it will notify the applicant in writing of the decision and the work will be registered. However, if the Registration Program again refuses to register the work, it will send the applicant a written notification stating the reasons for refusal within four months of the date on which the first request for reconsideration is received by the Registration Program. When the ending date for the four-month time period falls on a weekend or a Federal holiday, the ending day of the four-month period shall be extended to the next Federal work day. Failure by the Registration Program to send the written notification within the four-month period shall not result in registration of the applicant's work.
(c) Second reconsideration. Upon receiving written notification of the Registration Program's decision to refuse registration in response to the first request for reconsideration, an applicant may request that the Review Board reconsider the Registration Program's refusal to register, subject to the following requirements:
(1) An applicant must request in writing that the Review Board reconsider the Registration Program's decision to refuse registration. The second request for reconsideration must include the reasons the applicant believes registration was improperly refused, including any legal arguments in support of those reasons and any supplementary information, and must address the reasons stated by the Registration Program for refusing registration upon first reconsideration. The Board will base its decision on the applicant's written submissions.
(2) The fee set forth in §201.3(d)(3)(ii) of this chapter must accompany the second request for reconsideration.
(3) The second request for reconsideration and the applicable fee must be received in the Copyright Office no later than three months from the date that appears in the Registration Program's written notice of its decision to refuse registration after the first request for reconsideration. When the ending date for the three-month time period falls on a weekend or a Federal holiday, the ending day of the three-month period shall be extended to the next Federal work day.
(4) If the Review Board decides to register an applicant's work in response to a second request for reconsideration, it will notify the applicant in writing of the decision and the work will be registered. If the Review Board upholds the refusal to register the work, it will send the applicant a written notification stating the reasons for refusal.
(d) Submission of reconsiderations.—(1) All submissions for reconsideration should be mailed to the address specified in §201.1 of this chapter.
(2) The first page of the written request must contain the Copyright Office control number and clearly indicate either “FIRST RECONSIDERATION” or “SECOND RECONSIDERATION,” as appropriate, on the subject line.
(e) Suspension or wavier of time requirements. For any particular request for reconsideration, the provisions relating to the time requirements for submitting a request under this section may be suspended or waived, in whole or in part, by the Register of Copyrights upon a showing of good cause. Such suspension or waiver shall apply only to the request at issue and shall not be relevant with respect to any other request for reconsideration from that applicant or any other applicant.
(f) Composition of the Review Board. The Review Board shall consist of three members; the first two members are the Register of Copyrights and the General Counsel or their respective designees. The third member will be designated by the Register.
(g) Final agency action. A decision by the Review Board in response to a second request for reconsideration constitutes final agency action.
[69 FR 77636, Dec. 28, 2004, as amended at 70 FR 7177, Feb. 11, 2005; 73 FR 37839, July 2, 2008; 78 FR 42875, July 18, 2013]