Federal Register Vol. 83, No.63,

On April 16, 2016, GAO published a proposed rule (81 FR 22197) to amend its Bid Protest Regulations. The supplementary information included with the proposed rule explained that the proposed revisions to GAO's Bid Protest Regulations were promulgated in accordance with CICA, as the result of a statutory requirement imposed by the Consolidated Appropriations Act for 2014, Public Law 113-76, 128 Stat. 5 (Jan. 14, 2014). Section 1501 of this act directs GAO to establish and operate an electronic filing and document dissemination system, “under which, in accordance with procedures prescribed by the Comptroller General—(A) a person filing a protest under this subchapter may file the protest through electronic means; and (B) all documents and information required with respect to the protest may be disseminated and made available to the parties to the protest through electronic means.” Public Law 113-76, div. I, title I, sec. 1501, 128 Stat. 5, 433-34 (Jan. 17, 2014). The proposed rule advised that GAO was developing the system, which is called the Electronic Protest Docketing System (EPDS). As of the effective date of this final rule, EPDS will be the sole means for filing a bid protest at GAO (with the exception of protests containing classified information) and will enable parties to a bid protest and GAO to file and receive documents. Additional guidance for the use of EPDS is provided by GAO in the EPDS Instructions, which are available at https://epds.gao.gov/login.

In addition to directing GAO to establish and operate an electronic filing and document dissemination system, sec. 1501 of the Consolidated Appropriations Act for 2014 authorizes GAO to “require each person who files a protest under this subchapter to pay a fee to support the establishment and operation of the electronic system under this subsection.” Public Law 113-76, div. I, title I, sec. 1501, 128 Stat. 5, 434 (Jan. 17, 2014). The proposed rule advised that GAO will require persons filing a protest to pay a fee to file a protest through EPDS, and that GAO anticipates that the fee will be $350. Additional guidance regarding procedures for payment of the fee is available in the EPDS Instructions.

Finally, the proposed rule addressed other administrative changes to reflect current practice and to streamline the bid protest process.

GAO received a total of 34 timely comments by the closing date of May 16, 2016. GAO received 6 comments from federal agencies; 11 comments from businesses (including 2 comments from the same business on different dates), all of which were identified as small businesses; 2 comments from professional associations; 3 comments from law firms and consulting firms; and 12 comments from individuals or anonymous commentators. In adopting this final rule, GAO has carefully considered all comments received.

Seven commentators requested additional information as to how EPDS will function. For example, the commentators asked for information concerning how the implementation of EPDS will occur, how to pay the fee, how documents will be uploaded and distributed through EPDS, how agencies will be notified by GAO of the filing of a protest, and the security provisions for EPDS.

GAO response: The purpose of the proposed revisions to our regulations is to implement sec. 1501 of the Consolidated Appropriations Act for Fiscal Year 2014 and to make certain administrative changes to reflect current practice and to streamline the bid protest process. GAO has issued guidance regarding EPDS, including the transition to EPDS, at https://epds.gao.gov/login. Additional information regarding the procedures for using EPDS is available in the EPDS Instructions.

GAO proposed to revise redesignated paragraph (g) of 4 CFR 21.1 to clarify how a document is “filed” under GAO's Bid Protest Regulations by specifying that EPDS will be the sole method for filing a document with GAO for a bid protest—with the exception of protests containing classified material, as explained in a sentence added to the revised paragraph (h) of 4 CFR 21.1. The revisions throughout this final rule reflect that all filings are presumed to be made through EPDS (with the exception of protests containing classified material), which will enable the parties and GAO to file and receive documents.

Two commentators suggested that the proposed rule at paragraph (h) of 4 CFR 21.1, which states that classified documents “may not” be filed through EPDS, should be revised to use more expressly prohibitive language.

GAO response: GAO agrees with the suggestion and will revise our regulations to state that documents with classified material “shall not” be filed through EPDS.

One commentator requested that GAO clarify that the prohibition on filing documents containing “classified” material does not refer to proprietary or source-selection sensitive information.

GAO response: GAO does not believe that the rule requires clarification, but affirms here that the term “classified” refers to information deemed classified by a United States government agency for national security reasons, and not to information that is proprietary or source-selection sensitive.

One commentator requested that we revise the rules to provide for alternative filing procedures for documents that contain classified material.

GAO response: As discussed above, the EPDS Instructions provide guidance regarding the use of EPDS. Consistent with current practice, the EPDS Instructions direct parties to contact GAO for guidance in filing documents that contain classified material.

One commentator opposed the proposed rule in redesignated paragraph (g) of 4 CFR 21.1 that EPDS will be the sole means for filing documents in a bid protest. The commentator expressed concern that some documents may be unsuitable due to size or other formatting issues for electronic submission.

GAO response: GAO confirms that EPDS will be the sole means for filing documents in connection with a protest, with two exceptions: (1) Documents containing classified material, and (2) documents that, for reasons of size or format, are not suitable for filing through EPDS. The EPDS Instructions address the process for filing these two categories of documents.

The final rule makes additional minor corrections to paragraphs (c), (f), and (h) of 4 CFR 21.3 to reflect that documents must be filed through EPDS.

The proposed rule advised that GAO anticipates requiring persons filing a protest to pay a fee to file a protest through EPDS, which, as discussed above, will be the sole means for filing a bid protest at GAO. GAO advised that the anticipated fee will be $350. The EPDS Instructions address how persons filing a protest must pay the fee, and the circumstances under which the fee will apply. A fee will be required for filing a protest. At this time, additional fees will not be required for supplemental protests, requests for reconsideration, requests for recommendation for reimbursement of costs, or requests for recommendation on the amount of costs.

GAO received six comments in favor of the proposed fee.

Five commentators advocated for a higher fee. One commentator proposed requiring an additional, potentially higher fee for each supplemental protest, because, in the commentator's view, protesters routinely supplement their protests with more arguments in an attempt to circumvent timeliness or engage in “gamesmanship.” One commentator proposed requiring protesters to file fees based on a graduated scale to discourage what the commentator viewed as “serial” or frequent protesters. Under the proposed graduated scale, a protester would be required to file higher fees if it files multiple protests during the course of a year, e.g., a base fee for the first five protests, twice the base fee for more than five but less than eight protests, and four times the base fee for more than eight protests.

One commentator suggested that a fee of up to $1,000 would be appropriate, and that the overall goal of the fee should be the reduction of GAO's caseload, which would in turn permit GAO to issue decisions in fewer days. The same commentator suggested that a fee that was based on a percentage of the value of the procurement could be appropriate.

One commentator supported the fee and expressed the view that a fee could discourage “frivolous” protests.

Fifteen commentators opposed the proposed fee. All of the commentators opposed to the fee recommended that GAO either establish a lower fee for small businesses or waive the fee for small businesses.

Fourteen commentators opposed the fee on the basis that the fee creates a barrier to filing protests for small businesses, some of which stated that they lack the resources to pay the fee. In particular, one commentator argued that a $350 fee would make a protest economically infeasible for small businesses seeking the award of very small contracts.

Two commentators argued that because GAO is funded through appropriated funds a separate fee for bid protests is not warranted.

One commentator argued that a fee is not justified because GAO's bid protest forum is not staffed by judges, and that a fee should not be imposed in a manner similar to that imposed by a court. Another commentator argued that a fee is not justified because GAO does not have the same authority to enforce its decisions as a court.

One commentator argued that the fee is an attempt by GAO to discourage bid protests and thereby limit oversight over improper contracting actions by agencies. The commentator opposed the fee based on what the commentator views as GAO's failure to be an effective forum for the resolution of protests concerning small businesses, veteran-owned small businesses, and service-disabled veteran-owned small businesses. The commentator also opposed the fee on the basis that GAO failed to conduct adequate outreach to service-disabled veteran-owned small businesses—in particular, the commentator.

One commentator, while not expressly opposed to the fee, proposed a periodic reassessment of the fee to consider its impact on small business.

GAO response: GAO has considered all of the comments submitted regarding the proposed fee for filing a protest through EPDS. Additionally, GAO solicited views concerning the proposed fee from a number of business groups and associations that represent small businesses, including veteran-owned businesses, women-owned businesses, and minority-owned businesses. Further, although GAO is not subject to the Administrative Procedures Act, GAO voluntarily issued the proposed rule (81 FR 22197, Apr. 16, 2016) and invited comments.

As discussed in the proposed rule, sec. 1501 of the Consolidated Appropriations Act for 2014 directs GAO to establish and operate an electronic filing and document dissemination system, and authorizes GAO to “require each person who files a protest under this subchapter to pay a fee to support the establishment and operation of the electronic system under this subsection.” Public Law 113-76, div. I, title I, sec. 1501, 128 Stat. 5, 434 (Jan. 17, 2014). GAO derived the $350 fee using a methodology that took into account development costs for EPDS, estimates of hosting and maintenance costs, estimates of future bid protest filings, and a recovery period for development costs of approximately seven years.

GAO does not intend for the fee to discourage or reduce the number of protests. Rather, the proposed fee will cover the costs of establishing and operating EPDS. GAO does not agree with the proposals to charge a fee that is higher than necessary to address the costs of EPDS or for the purpose of discouraging protests. With regard to a lower fee or fee waiver for small businesses, GAO has concluded that the anticipated fee of $350 is appropriate given the costs of the system. Additionally, GAO has concluded that the interest of administrative efficiency supports imposition of a uniform fee for all protests.

GAO will monitor the fee to ensure that it is properly calibrated to recover the costs of establishing and maintaining the system. Any adjustment to the fee based on the review will reflect changes in the costs of EPDS, as is consistent with the statutory direction.

In addition to the comments regarding the requirement for a fee and the amount of the fee, GAO received six additional comments.

One commentator proposed that the requirement to pay a fee be expressly incorporated into 4 CFR 21.1, and that the regulation specify that failure to pay the fee will result in dismissal of a protest.

GAO response: GAO believes that the proposed rule makes clear that filing protests through EPDS is mandatory, other than classified protests, and GAO has advised that filing a protest through EPDS will require a fee. The EPDS Instructions provide additional guidance for the use of EPDS. GAO confirms that EPDS will not permit the filing of a protest without confirmation of payment. GAO also confirms that the filing of classified protests will also require payment of a fee.

Three commentators recommended that protesters be automatically refunded or reimbursed the fee if GAO sustains a protest.

GAO response: GAO does not agree that the fee should be automatically reimbursed by GAO if a protest is sustained. Instead, paragraph (d) of 4 CFR 21.8 provides that, if GAO sustains a protest, GAO may recommend that the agency reimburse the protester's costs of pursuing its protest. Additionally, paragraph (e) of 4 CFR 21.8 provides that, where an agency takes corrective action in response to a protest, the protester may request that GAO recommend that the agency reimburse the protester's costs of pursuing its protest. Fees will be reimbursable costs of pursuing a protest in the event GAO recommends that the agency reimburse protest costs.

Two commentators proposed that protesters be automatically refunded or reimbursed the fee if an agency takes corrective action in response to a protest.

GAO response: GAO does not agree that the fee should be automatically reimbursed by GAO if an agency takes corrective action in response to a protest. Instead, paragraph (e) of 4 CFR 21.8 provides that, if an agency decides to take corrective action in response to a protest, the protester may request that GAO recommend that the agency reimburse the protester's costs of pursuing the protest. Fees will be reimbursable costs of pursuing a protest in the event GAO recommends that the agency reimburse protest costs.

One commentator asked whether, in light of the requirement to file all documents with GAO through EPDS, protesters will continue to be required to provide a copy of the protest to the contracting officer, as required by paragraph (e) of 4 CFR 21.1.

GAO response: GAO did not revise the requirement to provide a copy of the protest to the contracting officer, as required by paragraph (e) of 4 CFR 21.1. GAO believes that this requirement, which is separate from the requirement to file documents with GAO through EPDS, remains an important requirement so that contracting officers are provided prompt notice of protests, which enables them to meet their obligations to notify interested parties, as required by Federal Acquisition Regulation section 33.104(a)(2) and paragraph (a) of 4 CFR 21.3.

One commentator requested that redacted versions of protests should be posted in EPDS in a manner that is available to the public.

GAO response: EPDS does not allow access to documents, redacted or otherwise, to non-parties.

GAO proposed to revise paragraph (a) of 4 CFR 21.2 to clarify that where a basis for challenging a solicitation becomes known after the solicitation's closing date, but the solicitation does not establish a new closing date, the protest must be filed within 10 days of when the protester knew or should have known of that basis—regardless of whether the time period for filing other protest claims was “tolled” because a required debriefing had been requested. The revision was proposed to address a conflict as to which of our timeliness rules—21.2(a)(1) or 21.2(a)(2)—takes precedence where a solicitation impropriety becomes apparent after proposals have been submitted, but there is no opportunity to submit revised proposals. Our Office addressed this issue in two decisions: Protect the Force, Inc.—Reconsideration, B-411897.3, Sept. 30, 2015, 2015 CPD ¶ 306, and Armorworks Enterprises, LLC, B-400394, B-400394.2, Sept. 23, 2008, 2008 CPD ¶ 176. The revision as proposed makes 4 CFR 21.2(a)(2) consistent with the policy outlined in those decisions.

One commentator opposed the proposed revision to paragraph (a)(2) of 4 CFR 21.2 and argued that the policy established in the two decisions should be reversed. The commentator argued that allowing protests concerning this type of solicitation impropriety to be “tolled” until after a required and requested debriefing has been provided would avoid the possibility of a protester with “mixed” protest claims (i.e., claims of an alleged solicitation impropriety as well as claims concerning the source selection) from being required to file two separate protests.

GAO response: GAO believes the revision is necessary to reflect our decisions and to avoid the conflict in the current rules. As an initial matter, the circumstance described by the commentator arises in exceedingly few protests. In any event, and as discussed in the two decisions that address this issue, there is sound policy underlying the proposed revision. Namely, the revision advances the principle that allegations of solicitation improprieties should be resolved as early as possible in the procurement process in order to promote fairness and efficiency. Further, adopting the policy advocated by the commentator could result in protesters and agencies unnecessarily expending time and resources on actions—such as preparing a protest concerning a source selection decision, in the protester's case, and preparing and providing debriefings, in the agency's case—in instances where there is merit in the allegation regarding the solicitation impropriety. For these reasons, we decline to eliminate the revision as requested by the commentator.

GAO proposed to revise paragraph (a) of 4 CFR 21.3 to require that parties to a protest provide copies of all protest communications “to the agency and to other participating parties” either through EPDS or email.

Three commentators expressed concern that the proposed revision would require parties to copy all other parties on all exchanges concerning the protest, including strategy or settlement communications.

GAO response: The proposed revision to paragraph (a) of 4 CFR 21.3 was not intended to prohibit the parties from engaging in communications that do not involve GAO, or communications between some, but not all parties. Rather, the rule was intended to update the current rule to include EPDS. The current rule requires all parties to be copied on all protest communications, which, in practice, means that when a party communicates with GAO, it must copy the other parties. To avoid confusion, GAO will revise the final rule to provide that parties must copy all other parties on communications with GAO.

Two commentators requested clarification as to how GAO will communicate with parties after the implementation of EPDS.

GAO response: As discussed above, the EPDS Instructions provide guidance regarding the use of EPDS. EPDS will provide email notification to parties of communications by GAO to the parties transmitted through EPDS. GAO also anticipates that some communications to the parties will continue to be made through email and telephone, as appropriate.

GAO proposed to revise paragraph (c) of 4 CFR 21.3 to clarify that if the fifth day for filing the agency's required response to a protester's request for documents falls on a weekend or federal holiday, the response shall be filed on the last business day that precedes the weekend or federal holiday.

One commentator expressed support for the revision to paragraph (c) because it avoids a potential ambiguity as to the due date for the agency's response.

One commentator objected to the revision to paragraph (c) because it results in less time for agencies to prepare their responses to document requests and allows protesters more time to object to an agency's list of documents to be filed.

GAO response: GAO believes that a revision to the date for the agency's response is required due to a potential ambiguity when the due date falls on a weekend or federal holiday. The resolution of the ambiguity necessarily results in either a longer or shorter time for agencies to respond. GAO concludes that a potentially shorter time for the agency's response, and potentially longer time for the protester to identify concerns or objections regarding the agency's response, is consistent with our statutory obligation to resolve protests within 100 days.

One commentator suggested that the requirement to file an agency's response “on the last business day . . .”, should be revised to require filing “by the last business day . . .”, to reflect an agency may file its response earlier.

GAO response: GAO agrees that the use of the term “by,” rather than “on” is appropriate and will revise paragraph (c) of 4 CFR 21.3 in the final rule to reflect this change.

One commentator expressed the view that paragraph (d) of 4 CFR 21.3, which requires the agency report to “include” a contracting officer's statement, inadvertently suggests that the memorandum of law is part of the contracting officer's statement.

GAO response: Although this language was not proposed for revision, and does not appear to have caused confusion for agencies in the preparation of their agency reports, GAO agrees that placing the phrase “including a best estimate of the contract value” in parentheses avoids any implication that the contracting officer is responsible for preparing a memorandum of law. This revision is reflected in the final rule.

One commentator objected to the revision to paragraph (d) of 4 CFR 21.3, which currently requires the agency report to include a copy of the protest. The commentator argued that the protest is a relevant document that should be included in the report.

GAO response: We believe that inclusion of a copy of the protest is no longer required because this document will already have been filed through EPDS. This revision is reflected in the final rule.

GAO proposed to redesignate paragraph (b) of 4 CFR 21.4 as paragraph (c), redesignate paragraph (c) as paragraph (d), redesignate paragraph (d) as paragraph (e), and add a new paragraph (b). New paragraph (b) provides that when parties file documents that are covered by a protective order, the parties must provide copies of proposed redacted versions of the document to the other parties within 1 day after the protected version is filed. Proposed redacted versions of documents should not be filed through EPDS; rather, the party responsible for preparing the proposed redacted version of the document should provide the document to the other parties by email or facsimile. New paragraph (b) provides that, where appropriate, the exhibits to the agency report or other documents may be proposed for redaction in their entirety. Additionally, new paragraph (b) provides that the party that files the protected document must file through EPDS within 5 days a final, agreed-to redacted version of the document. New paragraph (b) also directs the parties to seek GAO's resolution of any disputes concerning redacted documents.

Five commentators expressed concern that requirements to prepare and review proposed and final redacted versions of documents will place a burden on parties because of the resources required to prepare and approve the redactions. One commentator argued that a requirement to prepare redacted versions of all documents filed under a protective order would be inconsistent with GAO's statutory mandate under CICA to provide for the inexpensive resolution of bid protests.

Two commentators expressed the view that the “current practice” for parties filing protected documents is for the parties to negotiate among themselves as to which documents should remain under the protective order in their entirety and which documents should be redacted for release outside the protective order. These commentators suggested that the proposed rule in new paragraph (b) be revised to allow the parties “flexibility” in deciding which documents to redact. One commentator expressed concern that the requirement that the agency prepare redacted versions that inform pro se parties will be burdensome. Another commentator expressed specific concern with regard to pro se intervenors where there is a protester represented by counsel admitted to a protective order.

GAO response: Paragraph 2 of GAO's standard protective order requires parties to file proposed redacted versions of every document marked protected. GAO recognizes, however, that the practice among parties in many protests is to agree not to prepare redacted versions of all documents. GAO also recognizes that preparation of redacted versions of documents requires resources on the part of the parties that prepare them and on the part of the other parties who must review them. GAO will revise new paragraph (b) of 4 CFR 21.4 to provide that when a party files a document in EPDS that is marked protected, that party must, at the request of another party, provide a proposed redacted version of the document to the requesting party within 2 days. This revision is intended to balance the legitimate interest in providing public versions of documents against the parties' costs of preparing and reviewing such documents.

One commentator requested that new paragraph (b) of 4 CFR 21.4 expressly permit party-specific redactions, for example, redactions that may be released only to either the protester or intervenor.

GAO response: GAO has not opposed the preparation and approval of party-specific redactions. Neither 4 CFR 21.4 nor the protective order prohibit this practice, and GAO does not see a need to address this matter in the rule.

One commentator noted that the proposed rule stated that “Proposed redacted versions of documents should not be filed through EPDS; rather, the party responsible for preparing the proposed redacted version of the document should provide the document to the other parties by email or facsimile.” The commentator suggested that there is no reason to limit the non-EPDS exchanges between the parties to email or facsimile.

GAO response: Although this instruction was not included in the text of the revised regulation, GAO agrees with the commentator that there is no reason to limit the non-EPDS exchanges between the parties to email or facsimile.

GAO proposed to add paragraph (l) of 4 CFR 21.5 to reference the provisions of 10 U.S.C. 2304c(e)(1) and 41 U.S.C. 4106(f)(1), which limit GAO's jurisdiction to hear protests in connection with the issuance or proposed issuance of a task or delivery order issued under indefinite-delivery, indefinite-quantity contracts where the order is valued at dollar thresholds established by the statutory provisions, unless it is alleged that the order increases the scope, period, or maximum value of the contract under which the order was issued.

One commentator proposed that paragraph (l) of 4 CFR 21.5 be revised to clarify that GAO has jurisdiction to hear protests concerning orders issued under the Federal Supply Schedule (FSS).

GAO response: The proposed rule states that GAO's jurisdiction to review protests of orders issued under task or delivery order contracts is limited by the provisions of 10 U.S.C. 2304c(e)(1) and 41 U.S.C. 4106(f)(1), which were enacted as part of the Federal Acquisition Streamlining Act of 1994 (FASA), as amended. As GAO has explained in numerous bid protest decisions, the statutory authority under FASA for agencies to award multiple-award task and delivery order contracts and issue orders under those contracts is separate from the statutory authority to award multiple-award FSS contracts and for agencies to issue orders under those contracts. E.g., Severn Cos., Inc., B-275717.2, Apr. 28, 1997, 97-1 CPD ¶ 181. For this reason, we have concluded that the jurisdictional limitations on GAO's review of orders issued under task or delivery order contracts pursuant to FASA does not affect our Office's jurisdiction to hear protests concerning orders issued under the FSS. Because the proposed revision addresses only the jurisdictional limits under FASA, we see no reason to add additional provisions addressing the FSS.

GAO proposed to add paragraph (m) to 4 CFR 21.5 to clarify that GAO has the authority to review protests that an agency is improperly using a non-procurement instrument.

One commentator proposed that we clarify that our review of protests alleging that an agency is improperly using a non-procurement instrument is limited to whether an agency is improperly using the non-procurement instrument to procure goods or services.

GAO response: We agree that the proposed clarification reflects the longstanding practice by our Office to review such protests and will revise paragraph (m) of 4 CFR 21.5 in the final rule to reflect that GAO will review protests that an agency is improperly using a non-procurement instrument to procure goods or services.

GAO proposed to revise 4 CFR 21.6 to require agencies to file a notification in instances where it overrides a requirement to withhold award or suspend contract performance, and to file a copy of any issued determination and finding.

One commentator questioned why GAO proposed to require this information, in light of the statement in the same paragraph that “GAO does not administer the requirements to stay award or suspend contract performance under CICA at 31 U.S.C. 3553(c) and (d).”

GAO response: GAO's proposed rule noted that 31 U.S.C. 3554(b)(2) requires our Office to consider the basis for an agency's override in determining the remedy to recommend in the event we sustain a protest. To further clarify, 31 U.S.C. 3554(b)(2) states that if an agency issues an override based on the “best interests of the United States,” then GAO shall make a recommendation upon sustaining a protest “without regard to any cost or disruption from terminating, recompeting, or reawarding the contract.” Since this statutory provision requires GAO to consider the basis for any agency's override decision, GAO proposed to revise 4 CFR 21.6.

One commentator objected to the requirement to file the override decision, and proposed that agencies be required to advise GAO whether an override decision was based on the “best interests of the United States,” or “urgent and compelling circumstances.”

GAO response: GAO agrees that the statutory requirement for our Office to issue recommendations that take into consideration the basis for an override can also be met if the agency advises GAO of that basis, without providing the decision itself. GAO is therefore issuing this final rule to state that, when an agency issues a determination and finding to override a requirement to withhold award or suspend contract performance, the agency must file either the determination and finding itself or a statement by the official who approved the determination and finding that specifies the statutory basis for the override.

One commentator proposed revising the proposed rule to state that the decision must be filed “unless classified.”

GAO response: GAO does not believe that a revision is required here, as the proposed revision to paragraph (h) of 4 CFR 21.1 states that documents containing classified material cannot be filed through EPDS. As explained above, this proposed revision is further revised in the final rule to make clear that documents containing classified material “shall not” be filed through EPDS.

GAO proposed revising paragraph (e) of 4 CFR 21.8 to provide that a protester must file comments on an agency's response to a request for a recommendation for reimbursement of costs within 10 days and to further provide that GAO will dismiss the request if the protester fails to file comments within 10 days.

One commentator opposed this proposed revision, arguing that GAO should consider requests even where the protester does not file comments on the agency's response. The commentator suggested that the agency's response to the request should be sufficient for GAO to rule on the request.

GAO response: A protester's comments on an agency's response to a request for a recommendation for reimbursement of protest costs are necessary to provide an adequate record for GAO to review in issuing its decision. GAO believes that where a protester fails to respond within 10 days—the same period of time permitted for filing comments on an agency report—it is appropriate to deem the protester as having abandoned its request. GAO does not believe that resolution of an abandoned request is an appropriate use of our Office's resources.

One commentator expressed concern that the requirement in paragraph (e) of 4 CFR 21.8 that agencies respond to a request for a recommendation for reimbursement of costs within 15 days will require agencies to address requests for costs that are contained in the initial protest—thus requiring the agency to address requests for costs within 15 days of a protest's initial filing, that is, before the due date for filing the agency report as required by paragraph (c) of 4 CFR 21.3.

GAO response: We do not agree with the commentator's interpretation of the requirements of paragraph (e) of 4 CFR 21.8. The plain language of paragraph (e) refers to requests filed by protesters for recommendation of reimbursement of costs after GAO dismisses a protest based on an agency's decision to take corrective action. For this reason, we see no basis to conclude that paragraph (e) requires an agency to file a response to a request that is made outside the procedures set forth in that paragraph.

One commentator proposed that we revise paragraph (e) to state that GAO will not recommend reimbursement of costs where an agency takes corrective action in response to a protest prior to providing the agency report. Another commentator proposed that we revise paragraph (e) to state that GAO will not recommend reimbursement of costs unless the agency has unreasonably delayed taking corrective action.

GAO response: Paragraph (e) of 4 CFR 21.8 provides that GAO “may recommend” reimbursement of protest costs where an agency has taken corrective action in response to a protest. The two commentators' suggestions relate to the legal standard applied by our Office in determining when a recommendation for reimbursement is appropriate. The proposed rule is meant to establish the procedure for filing requests for recommendation of reimbursement of costs and does not attempt to set forth the full legal standard that has been applied by our Office. Because it would be impractical to incorporate all circumstances encompassed within our decisions in this rule, we conclude that a revision is not necessary.

One commentator requested that we incorporate a reference to the legislative history concerning the statutory provision at 31 U.S.C. 3554(c), which provides that although reimbursement for a protester's legal fees shall be capped at $150 per hour, small businesses are not subject to this limitation. The commentator noted that the conference committee's report on FASA, which imposed the $150 per hour cap, stated as follows: “The conferees expect the Comptroller General to be vigilant in reviewing attorneys' fees to ensure that they are reasonable. The cap placed on attorneys' fees for businesses other than small business constitutes a benchmark as to what constitutes a `reasonable' level for attorneys' fees for small businesses.” H. Rept. 103-712, section 1403 (Aug. 21, 1994), as reprinted in 1994 U.S.C.C.A.N. 2607, 2621-22.

GAO response: Our Office previously addressed this provision in a decision recommending the amount of attorneys' fees to be reimbursed for a small business whose protest had been sustained. See Public Communications Services, Inc.—Costs, B-400058.4, June 25, 2009, 2009 CPD ¶ 131. In that decision, GAO stated that “we recognize that the FASA conference committee reiterated our Office's responsibility, imposed in 1984 by CICA, to ensure that attorneys' fees sought for reimbursement are reasonable.” Id. at 8. Nonetheless, we concluded “we do not view the benchmark language as imposing an additional limitation (i.e., a cap) on attorneys' fees that are otherwise reasonable,” because “[s]uch an interpretation would be inconsistent with the plain statutory language of FASA which exempts small businesses from the specific cap imposed on large businesses—and we see no evidence that the Congress intended such a result.” Id. Because this matter was fully addressed in Public Communications Services, Inc.—Costs, we see no reason to add the benchmark language to the final regulation.

GAO proposed to revise 4 CFR 21.10 to reflect the requirement to file documents through EPDS.

One commentator proposed that we revise the flexible schedule procedures in 4 CFR 21.10 to provide that GAO will seek the “concurrence” of the parties before using an alternate schedule. The commentator notes that the flexible schedule procedures, in particular the express option schedule, may change the parties' filing dates and reduce the amount of time for filings.

GAO response: As a matter of practice, GAO considers the views of the parties when using the flexible schedule procedures in 4 CFR 21.10. However, GAO reserves the right to use these procedures even where the parties do not concur. GAO believes that the use of flexible schedule procedures aids our Office's ability to meet our statutory obligations to provide an inexpensive and expeditious forum for the resolution of protests.

Although not addressed in our proposed rule, GAO will revise 4 CFR 21.13(b) to clarify that certain provisions of 4 CFR do not apply to nonstatutory protests. The rule currently states that GAO will not issue recommendations for the payment of costs associated with nonstatutory protests, as otherwise provided for in 4 CFR 21.8(d). The revised rule clarifies that GAO will also not issue recommendations for the payment of costs when an agency takes corrective action in response to a nonstatutory protest, as otherwise provided for in 4 CFR 21.8(e). The revised rule also clarifies that 4 CFR 21.6, which pertains to the withholding of award and the suspension of contract performance pursuant to 31 U.S.C. 3553(c) and (d), does not apply to nonstatutory protests.

For the reasons set out in the preamble, title 4, chapter I, subchapter B, part 21 of the Code of Federal Regulations is amended as follows:

Table of Contents I. Statutory and Regulatory Background II. Overview of Final Rule III. Adjustments by Component A. National Protection and Programs Directorate B. U.S. Customs and Border Protection C. U.S. Immigration and Customs Enforcement D. U.S. Coast Guard E. Transportation Security Administration IV. Administrative Procedure Act V. Regulatory Analyses A. Executive Orders 12866 and 13563 B. Regulatory Flexibility Act C. Unfunded Mandates Reform Act D. Paperwork Reduction Act I. Statutory and Regulatory Background

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74 section 701 (Nov. 2, 2105)) (2015 Act).1 The 2015 Act amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note) to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act required agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through issuance of an Interim Final Rule (IFR) and (2) make subsequent annual adjustments for inflation. Through the “catch-up” adjustment, agencies were required to adjust the maximum amounts of civil monetary penalties to more accurately reflect inflation rates.

For the subsequent annual adjustments, the 2015 Act requires agencies to increase the penalty amounts by a cost-of-living adjustment. The 2015 Act directs OMB to provide guidance to agencies each year to assist agencies in making the annual adjustments. The 2015 Act requires agencies to make the annual adjustments no later than January 15 of each year and to publish the adjustments in the Federal Register.

Pursuant to the 2015 Act, DHS undertook a review of the civil penalties that DHS and its components administer.2 On July 1, 2016, DHS published an IFR adjusting the maximum civil monetary penalties with an initial “catch-up” adjustment, as required by the 2015 Act. See 81 FR 42987. DHS calculated the adjusted penalties based upon nondiscretionary provisions in the 2015 Act and upon guidance that OMB issued to agencies on February 24, 2016.3 The adjusted penalties were effective for civil penalties assessed after August 1, 2016 (the effective date of the IFR) whose associated violations occurred after November 2, 2015 (the date of enactment of the 2015 Act). On January 27, 2017, DHS published a final rule finalizing the IFR and making the annual adjustment for 2017. See 82 FR 8572.

This final rule makes the 2018 annual inflation adjustments to civil monetary penalties pursuant to the 2015 Act and pursuant to guidance OMB issued to agencies on December 15, 2017.4 The penalty amounts in this final rule will be effective for penalties assessed after April 2, 2018 where the associated violation occurred after November 2, 2015. Consistent with OMB guidance, the 2015 Act does not change previously assessed penalties that the agency is actively collecting or has collected.

The adjusted penalty amounts will apply to penalties assessed after the effective date of this final rule. We discuss civil penalties by DHS component in Section III below. For each component identified in Section III, below, we briefly describe the relevant civil penalty (or penalties), and we provide a table showing the increase in the penalties for 2018. In the table for each component, we show (1) the penalty name, (2) the penalty statutory and/or regulatory citation, (3) the penalty amount as adjusted in the 2017 final rule, (4) the cost-of-living adjustment multiplier for 2018 that OMB provided in its December 15, 2017 guidance, and (5) the new 2018 adjusted penalty. The 2015 Act instructs agencies to round penalties to the nearest $1. For a more complete discussion of the method used for calculating the initial “catch-up” inflation adjustments and a component-by-component breakdown to the nature of the civil penalties and relevant legal authorities, please see the IFR preamble at 81 FR 42987-43000.

In the following sections, we briefly describe the civil penalties that DHS and its components assess. We include tables at the end of each section, which list the individual adjustments for each penalty.

The National Protection and Programs Directorate (NPPD) administers only one civil penalty that the 2015 Act affects. That penalty assesses fines for violations of the Chemical Facility Anti-Terrorism Standards (CFATS). CFATS is a program that regulates the security of chemical facilities that, in the discretion of the Secretary, present high levels of security risk. DHS established the CFATS program in 2007 pursuant to section 550 of the Department of Homeland Security Appropriations Act of 2007 (Pub. L. 109-295).5 The CFATS regulation is located in part 27 of title 6 of the Code of Federal Regulations (CFR). Below is a table showing the 2018 adjustment for the CFATS penalty that NPPD administers.

U.S. Customs and Border Protection (CBP) assesses civil monetary penalties under various titles of the United States Code and the CFR. These include penalties for certain violations of title 8 of the CFR regarding the Immigration and Nationality Act of 1952 (Pub. L. 82-414, as amended) (INA). The INA contains provisions that impose penalties on persons, including carriers and aliens, who violate specified provisions of the INA. The relevant penalty provisions are located in numerous sections of the INA, however CBP has enumerated these penalties in regulation in one location—in 8 CFR 280.53. For a complete list of the INA sections for which penalties are assessed, in addition to a brief description of each violation, see the IFR preamble at 81 FR 42989-42990.

On December 8, 2017, CBP adjusted three non-INA penalties inadvertently left out of the IFR and 2017 final rule. See 82 FR 57821. The three penalties concern the following violations: Transporting passengers between coastwise points in the United States by a non-coastwise qualified vessel; towing a vessel between coastwise points in the United States by a non-coastwise qualified vessel; and dealing in or using an empty stamped imported liquor container after it has already been used once. This final rule incorporates those three penalties alongside the other CBP penalties and adjusts them according to the 2018 multiplier.

Below is a table showing the 2018 adjustment for the penalties that CBP administers.

U.S. Immigration and Customs Enforcement (ICE) assesses civil monetary penalties for certain employment-related violations arising from the INA. ICE's civil penalties are located in title 8 of the CFR.

There are three different sections in the INA that impose civil monetary penalties for violations of the laws that relate to employment actions: Sections 274A, 274B, and 274C. ICE has primary enforcement responsibilities for two of these civil penalty provisions (sections 274A and 274C), and the Department of Justice (DOJ) has enforcement responsibilities for one of these civil penalty provisions (section 274B). The INA, in sections 274A and 274C, provides for imposition of civil penalties for various specified unlawful acts pertaining to the employment eligibility verification process (Form I-9, Employment Eligibility Verification) and the employment of unauthorized aliens.

Because both DHS and DOJ implement the three employment-related penalty sections in the INA, both Departments' implementing regulations reflect the civil penalty amounts. For a complete description of the civil money penalties assessed and a discussion of DHS's and DOJ's efforts to update the penalties in years past, see the IFR preamble at 81 FR 42991. Below is a table showing the 2018 adjustment for the penalties that ICE administers.6

Part 391, subpart A, was included in the regulations that were transferred to the FDIC from the Office of Thrift Supervision (“OTS”) on July 21, 2011, in connection with the implementation of applicable provisions of title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”).1 With the exception of one provision (§ 391.5) the requirements for State savings associations in part 391, subpart A, are substantively identical to the requirements in the FDIC's 12 CFR part 326 (“part 326”), which is entitled “Minimum Security Procedures.” The one exception directs savings associations to comply with appendix B to subpart B of Interagency Guidelines Establishing Information Security Standards (Interagency Guidelines) contained in FDIC rules at part 364, appendix B. The FDIC previously revised part 364 to make the Interagency Guidelines applicable to both State nonmember banks and State savings associations.2

The FDIC is adopting a final rule (“Final Rule”) to rescind in its entirety part 391, subpart A and to modify the scope of part 326 to include State savings associations to conform to and reflect the scope of the FDIC's current supervisory responsibilities as the appropriate Federal banking agency. The FDIC is also adding definitions of “FDIC-supervised insured depository institution or institution” and “State savings association.” Upon removal of part 391, subpart A, the Security Procedures, regulations applicable for all insured depository institutions for which the FDIC has been designated the appropriate Federal banking agency will be found at 12 CFR part 326.

The Dodd-Frank Act provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, codified at 12 U.S.C. 5411, the powers, duties, and functions formerly performed by the OTS were divided among the FDIC, as to State savings associations, the Office of the Comptroller of the Currency (“OCC”), as to Federal savings associations, and the Board of Governors of the Federal Reserve System (“FRB”), as to savings and loan holding companies. Section 316(b) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(b), provides the manner of treatment for all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. This section provides that if such materials were in effect on the day before the transfer date, they continue to be in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law.

Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations that would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC's Board of Directors approved a “List of OTS Regulations to be Enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.” This list was published by the FDIC and the OCC as a Joint Notice in the Federal Register on July 6, 2011.3

Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank Act affected the FDIC's existing authority to issue regulations under the FDI Act and other laws as the “appropriate Federal banking agency” or under similar statutory terminology. Section 312(c) of the Dodd-Frank Act amended the definition of “appropriate Federal banking agency” contained in section 3(q) of the FDI Act, 12 U.S.C. 1813(q), to add State savings associations to the list of entities for which the FDIC is designated as the “appropriate Federal banking agency.” As a result, when the FDIC acts as the designated “appropriate Federal banking agency” (or under similar terminology) for State savings associations, as it does here, the FDIC is authorized to issue, modify, and rescind regulations involving such associations, as well as for State nonmember banks and insured branches of foreign banks.

As noted, on June 14, 2011, pursuant to this authority, the FDIC's Board of Directors reissued and redesignated certain transferring regulations of the former OTS. These transferred OTS regulations were published as new FDIC regulations in the Federal Register on August 5, 2011.4 When it republished the transferred OTS regulations as new FDIC regulations, the FDIC specifically noted that its staff would evaluate the transferred OTS rules, and might later recommend incorporating the transferred OTS regulations into other FDIC rules, amending them, or rescinding them as appropriate.

One of the OTS rules transferred to the FDIC governed OTS oversight of minimum security devices and procedures for State savings associations. The OTS rule, formerly found at 12 CFR part 568, was transferred to the FDIC with only nominal changes, and is now found in the FDIC's rules at part 391, subpart A, entitled “Security Procedures.” Before the transfer of the OTS rules and continuing today, the FDIC's rules contained part 326, subpart A, entitled “Minimum Security Procedures,” a rule governing FDIC oversight of security devices and procedures to discourage burglaries, robberies, and larcenies, and assist law enforcement in the identification and apprehension of those who commit such crimes with respect to insured depository institutions for which the FDIC has been designated the appropriate Federal banking agency. One provision in part 391, subpart A, namely § 391.5, is not contained in part 326, subpart A. It directs savings associations and certain subsidiaries to comply with the Interagency Guidelines Establishing Information Security Standards, which were adopted jointly by the OTS and the FDIC and other banking agencies, and are contained in appendix B to part 364 in FDIC regulations.

After careful review and comparison of part 391, subpart A, and part 326, the FDIC is adopting a Final Rule to rescind part 391, subpart A, because, as discussed below, it is substantively redundant to existing part 326, and simultaneously finalizes the technical conforming edits to the FDIC's existing rule.

Section 3 of the Bank Protection Act of 1968 directed the appropriate Federal banking agencies and the OTS' predecessor, the Federal Home Loan Bank Board (“FHLBB”), to establish minimum security standards for banks and savings associations, at reasonable cost, to serve as a deterrent to robberies, burglaries, and larcenies, and to assist law enforcement in identifying and prosecuting persons who commit such acts.5 In the initial rulemakings, the agencies consulted and cooperated with each other to promote a goal of uniformity where practicable. The initial minimum security rules were simultaneously issued in January 1969 and were substantively the same.6

In 1991, the minimum security rules were substantially revised to reduce unnecessary specificity, remove obsolete requirements, and place greater responsibility on the boards of directors of insured financial institutions for establishing and ensuring the implementation and maintenance of security programs and procedures. The former FHLBB rules at 12 CFR part 563a were redesignated as 12 CFR part 568 by the OTS. The OTS rules remained substantively the same as the FDIC's rules in part 326, subpart A.7

In 2001, the FDIC, other Federal banking agencies, and the OTS issued Interagency Guidelines for Safeguarding Customer Information pursuant to section 501 of the Gramm Leach Bliley Act (“Protection of Nonpublic Personal Information”).8 At the same time, the OTS added a provision at the end of its security procedures rules at section 568.5 directing saving associations and certain subsidiaries to comply with appendix B to the Interagency Guidelines. In a preamble footnote, the OTS indicated that the reason for the additional provision to its minimum security rules was “[b]ecause information security guidelines are similar to physical security procedures.” 9 In 2004, following enactment of the Fair and Accurate Credit Transactions Act (FACT Act), the OTS, FDIC, and other banking agencies revised the Interagency Guidelines for Safeguarding Customer Information and renamed them the Interagency Guidelines for Establishing Information Security Standards. The Interagency Guidelines were located in the FDIC rules at part 364. In 2015, the FDIC amended part 364 to, among other reasons, make it applicable to State savings associations.10 After careful comparison of the FDIC's part 326, subpart A, with the transferred OTS rule in part 391, subpart A, the FDIC has concluded that the transferred OTS rules governing minimum security procedures are substantively redundant. Based on the foregoing, the FDIC is adopting a Final Rule to rescind and remove from the Code of Federal Regulations the transferred OTS rules located at part 391, subpart A, and to make technical amendments to part 326, subpart A, to incorporate State savings associations.

Regarding the functions of the former OTS that were transferred to the FDIC, section 316(b)(3) of the Dodd-Frank Act, 12 U.S.C. 5414(b)(3), in pertinent part, provides that the former OTS's regulations will be enforceable by the FDIC until they are modified, terminated, set aside, or superseded in accordance with applicable law. After reviewing the rules currently found in part 391, subpart A, the FDIC issued a Notice of Proposed Rulemaking (“NPR” or “Proposed Rule”), which proposed to (1) rescind part 391, subpart A, in its entirety; (2) modify the scope of part 326, subpart A, to include State savings associations and their subsidiaries to conform to and reflect the scope of FDIC's current supervisory responsibilities as the appropriate Federal banking agency for State savings associations; (3) delete the definition of “insured nonmember bank” and replace it with a definition of “FDIC-supervised insured depository institution or institution,” which means “any State nonmember insured bank or State savings association for which the Federal Deposit Insurance Corporation is the appropriate Federal banking agency pursuant to section 3(q) of the Federal Deposit Insurance Act (12 U.S.C. 1813(q))”; (4) add a new subsection (i), which would define “State savings association” as having “the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act (12 U.S.C. 1813(b)(3))”; and (5) make conforming technical edits throughout, including replacing the term “bank” with “FDIC-supervised insured depository institution” or “institution”. Under the Proposed Rule, oversight of minimum security procedures in part 326, subpart A, would apply to all FDIC-supervised institutions, including State savings associations, and part 391, subpart A, would be removed because it is largely redundant of the rules found in part 326. Rescinding part 391, subpart A, will serve to streamline the FDIC's rules and eliminate unnecessary regulations.

The FDIC issued the NPR with a 60-day comment period, which closed on January 3, 2017. The FDIC received no comments on its Proposed Rule, and consequently the Final Rule is adopted as proposed without any changes.

As discussed in the NPR, with the exception of one provision (§ 391.5), the requirements for State savings associations in part 391, subpart A, are substantively identical to the requirements in the FDIC's 12 CFR part 326 (“part 326”). The one exception directs savings associations to comply with appendix B to subpart B of Interagency Guidelines Establishing Information Security Standards (Interagency Guidelines) contained in FDIC rules at part 364, appendix B. The FDIC previously revised part 364 to make the Interagency Guidelines applicable to both State nonmember banks and State savings associations. The designation of part 326 as a single authority regarding security standards and procedures will serve to streamline the FDIC's rules and eliminate unnecessary regulations. To that effect, the Final Rule removes and rescinds 12 CFR part 391, subpart A, in its entirety.

Consistent with the Proposed Rule, the Final Rule modifies the scope of part 326, subpart A, to include State savings associations and their subsidiaries to conform to and reflect the scope of FDIC's current supervisory responsibilities as the appropriate Federal banking agency for State savings associations. The Final Rule also deletes the definition of “insured nonmember bank” and replaces it with a definition of “FDIC-supervised insured depository institution or institution,” which means “any State nonmember insured bank or State savings association for which the Federal Deposit Insurance Corporation is the appropriate Federal banking agency pursuant to section 3(q) of the Federal Deposit Insurance Act (12 U.S.C. 1813(q)).” Additionally, the Final Rule adds a new subsection (i), which would define “State savings association” as having “the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act (12 U.S.C. 1813(b)(3)) and makes conforming technical edits throughout, including replacing the term “bank” with “FDIC-supervised insured depository institution” or “institution”.

In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number.

The Final Rule would rescind and remove part 391, subpart A, from the FDIC regulations. This rule was transferred with only nominal changes to the FDIC from the OTS when the OTS was abolished by title III of the Dodd-Frank Act. Part 391, subpart A, is substantively similar to the FDIC's existing part 326, subpart A, regarding oversight of minimum security procedures for depository institutions with the exception of one provision at the end of part 391, subpart A, which directs savings associations to comply with Interagency Guidelines, which are located in Appendix B to part 364. In 2015, the FDIC proposed and finalized revisions to part 364 that made part 364, including the Interagency Guidelines in Appendix B, applicable to State savings associations as well as State nonmember banks.

The Final Rule also (1) amends part 326, subpart A to include State savings associations and their subsidiaries within its scope; (2) defines “FDIC-supervised insured depository institution or institution” and “State savings association”; and (3) makes conforming technical edits throughout. These measures clarify that State savings associations, as well as State nonmember banks, are subject to part 326, subpart A. With respect to part 326, subpart A, the Final Rule does not revise any existing, or create any new information collection pursuant to the PRA. Consequently, no submission has been made to the Office of Management and Budget for review.

The Regulatory Flexibility Act requires an agency to consider the impact that a final rule will have on small entities (defined in regulations promulgated by the Small Business Administration to include banking organizations with total assets of less than or equal to $550 million).11 However, a regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory Statement in the Federal Register together with the rule. For the reasons provided below, the FDIC certifies that the Final Rule would not have a significant economic impact on a substantial number of small entities.

As discussed in the NPR, part 391, subpart A, was transferred from OTS part 568, which governed minimum security procedures for depository institutions. The initial minimum security rules, though issued separately by the agencies, were all published in January 1969. The OTS rule, part 568, had been in effect since 1991 and all State savings associations were required to comply with it. Because it is substantially the same as existing part 326, subpart A of the FDIC's rules and therefore redundant, the FDIC is adopting a final rule to rescind and remove the transferred regulation now located in part 391, subpart A. As a result, all FDIC-supervised institutions—including State savings associations and their subsidiaries—would be required to comply with the minimum security procedures in part 326, subpart A. Because all State savings associations and their subsidiaries have been required to comply with nearly identical security procedures rules since 1969, the Final Rule would not place additional requirements or burdens on any State savings association irrespective of its size. Therefore, the Final Rule would not have a significant impact on a substantial number of small entities.

The Office of Management and Budget has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), 5 U.S.C. 801 et seq. As required by SBREFA, the FDIC will submit the Final Rule and other appropriate reports to Congress and the Government Accountability Office for review.

Section 722 of the Gramm-Leach- Bliley Act, codified at 12 U.S.C. 4809, requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the NPR, the FDIC invited comments on whether the Proposed Rule was clearly stated and effectively organized, and how the FDIC might make it easier to understand. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.

Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (“EGRPRA”), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions.12 The FDIC, along with the other Federal banking agencies, submitted a Joint Report to Congress on March 21, 2017 (“EGRPRA Report”) discussing how the review was conducted, what has been done to date to address regulatory burden, and further measures we will take to address issues that were identified.13 As noted in the EGRPRA Report, the FDIC is continuing to streamline and clarify its regulations through the OTS rule integration process. By removing outdated or unnecessary regulations, such as part 391, subpart A, and modifying the Minimum Security Procedures, this rule complements other actions the FDIC has taken, separately and with the other Federal banking agencies, to further the EGRPRA mandate.

The Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA) requires the FDIC, in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. In addition, new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions generally must take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.14 The final rule includes no new reporting, disclosure, or other new requirements on insured depository institutions. Therefore, the final rule is not subject to the requirements of the statute.

For the reasons stated in the preamble, the Board of Directors of the Federal Deposit Insurance Corporation amends 12 CFR parts 326 and 391 as follows:

Part 390, subpart I was included in the regulations that were transferred to the FDIC from the Office of Thrift Supervision (“OTS”) on July 21, 2011, in connection with the implementation of applicable provisions of title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”). The requirements for State savings associations in part 390, subpart I are substantively similar to the requirements in the FDIC's 12 CFR part 343 (“part 343”) which is also entitled “Consumer Protection in Sales of Insurance.”

The FDIC is adopting a final rule to rescind in its entirety part 390, subpart I and to modify the scope of part 343 to include State savings associations and their subsidiaries to conform to and reflect the scope of the FDIC's current supervisory responsibilities as the appropriate Federal banking agency. The final rule also defines “FDIC-supervised insured depository institution or institution” and “State savings association.” In the final rule, the FDIC also transfers an anticoercion and antitying provision from part 390, subpart I that is applicable to State savings associations.

Upon removal of part 390, subpart I, the Consumer Protection in Sales of Insurance regulations applicable for all insured depository institutions for which the FDIC has been designated the appropriate Federal banking agency will be found at 12 CFR part 343.

The Dodd-Frank Act 1 provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, codified at 12 U.S.C. 5411, the powers, duties, and functions formerly performed by the OTS were divided among the FDIC, as to State savings associations, the Office of the Comptroller of the Currency (“OCC”), as to Federal savings associations, and the Board of Governors of the Federal Reserve System (“FRB”), as to savings and loan holding companies. Section 316(b) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(b), provides the manner of treatment for all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. This section provides that if such materials were in effect on the day before the transfer date, they continue to be in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law.

Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations that would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC's Board of Directors approved a “List of OTS Regulations to be enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.” This list was published by the FDIC and the OCC as a Joint Notice in the Federal Register on July 6, 2011.2

Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank Act affected the FDIC's existing authority to issue regulations under the Federal Deposit Insurance Act (“FDI Act”) and other laws as the “Appropriate Federal Banking Agency” or under similar statutory terminology. Section 312(c) of the Dodd-Frank Act amended the definition of “Appropriate Federal Banking Agency” contained in section 3(q) of the FDI Act, 12 U.S.C. 1813(q), to add State savings associations to the list of entities for which the FDIC is designated as the “appropriate Federal banking agency.” As a result, when the FDIC acts as the designated “Appropriate Federal Banking Agency” (or under similar terminology) for State savings associations, as it does here, the FDIC is authorized to issue, modify and rescind regulations involving such associations, as well as for State nonmember banks and insured branches of foreign banks.

As noted, on June 14, 2011, pursuant to this authority, the FDIC's Board of Directors reissued and redesignated certain transferring regulations of the former OTS. These transferred OTS regulations were published as new FDIC regulations in the Federal Register on August 5, 2011.3 When it republished the transferred OTS regulations as new FDIC regulations, the FDIC specifically noted that its staff would evaluate the transferred OTS rules and might later recommend incorporating the transferred OTS regulations into other FDIC rules, amending them, or rescinding them, as appropriate.

One of the OTS rules transferred to the FDIC governed OTS oversight of consumer protections for depository institution sales of insurance. The OTS rule, formerly found at 12 CFR part 536, was transferred to the FDIC with only nominal changes and is now found in the FDIC's rules at part 390, subpart I, entitled “Consumer Protection in Sales of Insurance.” Before the transfer of the OTS rules and continuing today, the FDIC's rules contained part 343, entitled “Consumer Protection in Sales of Insurance,” a rule governing FDIC oversight of consumer protection regulations that apply to retail sales practices, solicitations, advertising, or offers of any insurance product with respect to insured depository institutions for which the FDIC has been designated the appropriate Federal banking agency.

After careful review and comparison of part 390, subpart I, and part 343, the FDIC is adopting a final rule to rescind part 390, subpart I, because, as discussed below, it is substantively redundant to existing part 343 and simultaneously finalize technical conforming edits to the existing rule.

Section 305 of the Gramm-Leach-Bliley Act (“GLB Act”) 4 added section 47 to the FDI Act,5 entitled “Insurance Consumer Protections.” Section 47 applies to retail sales practices, solicitations, advertising, or offers of insurance products by depository institutions 6 or persons engaged in these activities at an office of the institution or on behalf of the institution.7 Section 47 directs the FDIC, the OTS, the OCC, and the FRB (collectively the “Federal banking agencies”) to include provisions specifically relating to sales practices, disclosures and advertising, the physical separation of banking and nonbanking activities, and domestic violence discrimination.8 On December 4, 2000, pursuant to section 305 of the GLB Act,9 the Federal banking agencies published a joint final rule 10 to implement consumer protection in sales of insurance provisions of section 47 of the FDI Act.

Section 47 of the FDI Act instructs the Federal banking agencies to consult and coordinate with one another and prescribe and publish joint consumer protection regulations that apply to retail sales practices, solicitations, advertising, or offers of insurance products by depository institutions or persons engaged in these activities at an office of the institution or on behalf of the institution.11 Section 47 also requires the Federal banking agencies to consult with the State insurance regulators, as appropriate.12 Pursuant to Section 47, the Federal banking agencies consulted and coordinated with respect to this rulemaking and on an interagency basis jointly issued rules that are substantively identical with regard to consumer protection in sales of insurance requirements,13 including the same definition of a “covered person” or “you.” 14

The scope of part 343 in the FDIC's regulations and of part 390, subpart I in the OTS's regulations is substantively similar. The FDIC regulations apply to any bank 15 or any other person that is engaged in such activities at an office of the bank or on behalf of the bank.16 Similarly, the OTS regulations apply to any State savings association or any other person that is engaged in such activities at an office of a State savings association or on behalf of a State savings association.17 In the FDIC's scope provisions, any other person includes subsidiaries 18 because only subsidiaries that are selling insurance products or annuities at an office of the institution or acting on behalf of the depository institution as defined in the rules would be subject to the requirements of the rules.19 The OTS regulation specifically states that its regulation applies to subsidiaries of a State savings association only to the extent that it sells, solicits, advertises, or offers insurance products or annuities at an office of a State savings association or on behalf of a State savings association.20 This OTS provision will not be carried over to the FDIC's part 343 because it is redundant and unnecessary, since the FDIC scope provision already includes subsidiaries within its definition.21 The rule specifically states that a covered person (or you) includes any person including a subsidiary or other affiliate if that person or one of its employees sells, solicits, advertises, or offers insurance products or annuities at an office of an institution or on behalf of an institution.22

Accordingly, the portions of the OTS regulations that applied to State savings associations, their subsidiaries and their affiliates, originally codified at 12 CFR part 536 and subsequently transferred to FDIC's part 390, subpart I, are substantively similar to the current FDIC regulations codified at 12 CFR part 343. By amending part 343 to encompass State savings associations and rescinding part 390, subpart I, the FDIC will streamline its regulations and reduce redundancy.

Although the former OTS rule and part 390, subpart I, covers savings and loan holding companies that are affiliated with savings associations in addition to savings associations, the FDIC does not supervise savings and loan or bank holding companies for purposes of this rule. Section 312 of the Dodd-Frank Act 23 divides and transfers the functions of the former OTS to the FDIC, OCC, and FRB by amending section 1813(q) of the FDI Act. Specifically, section 312 transfers the former OTS's power to regulate State savings associations to the FDIC, while it transfers the power to regulate savings and loan holding companies to the FRB.24 As a result, whereas the former OTS part 536 applied to savings associations, their subsidiaries and their affiliates, including savings and loan holding companies,25 upon transfer of part 536 to FDIC's part 390, subpart I, only the authority over State savings associations and their subsidiaries and other affiliates was transferred to the FDIC for purposes of this rule.26 The FRB currently has jurisdiction over the regulation and supervision of consumer protections in connection with retail insurance sales practices as it applies to affiliates, including savings and loan holding companies of State savings associations.27 For this reason, the existing references to affiliates in part 390, subpart I, are not transferred to part 343 of the FDIC rules.

After careful comparison of the FDIC's part 343 with the transferred OTS rule in part 390, subpart I, the FDIC has concluded that the transferred OTS rules governing consumer protection in sales of insurance are substantively redundant. Based on the foregoing, the FDIC is adopting a final rule to rescind and remove from the Code of Federal Regulations the transferred OTS rules located at part 390, subpart I, and to make technical and conforming changes to part 343 to incorporate State savings associations.

The functions of the former OTS that were transferred to the FDIC, section 316(b)(3) of the Dodd-Frank Act, 12 U.S.C. 5414(b)(3), in pertinent part, provide that the former OTS's regulations will be enforceable by the FDIC until they are modified, terminated, set aside, or superseded in accordance with applicable law. After reviewing the rules currently found in part 390, subpart I, on November 15, 2016 the FDIC published a Notice of Proposed Rulemaking (“NPR” or “Proposed Rule”) to (1) rescind part 390, subpart I, in its entirety; (2) modify to the scope of part 343 to include State savings associations and their subsidiaries to conform to and reflect the scope of FDIC's current supervisory responsibilities as the appropriate Federal banking agency for State savings associations; (3) delete the definition of “bank” and replace it with a definition of “FDIC-supervised insured depository institution or institution”, which means “any State nonmember insured bank or State savings association for which the Federal Deposit Insurance Corporation is the appropriate Federal banking agency pursuant to section 3(q) of the Federal Deposit Insurance Act (12 U.S.C. 1813(q));” (4) add a new subsection (i), which would define “State savings association” as having “the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act (12 U.S.C. 1813(b)(3));” (5) transfer an anticoercion and antitying provision from part 390, subpart I that is applicable to State savings associations to part 343; and (6) make conforming technical edits throughout, including replacing the term “institution” in place of “bank” throughout the rule where necessary.

Under the NPR, oversight of consumer protection in sales of insurance in part 343 would apply to all FDIC-supervised institutions, including State savings associations, and part 390, subpart I, would be removed because it is largely redundant of the rules found in part 343. Rescinding part 390, subpart I, would serve to streamline the FDIC's rules and eliminate unnecessary regulations.

The FDIC issued the NPR with a 60-day comment period which closed on January 20, 2017. The FDIC received no comments on its Proposed Rule. The final rule (“Final Rule”) is adopted as proposed without changes.

As discussed in the NPR, part 390, subpart I is substantively the same as the requirements in part 343 and therefore is redundant. The Final Rule removes and rescinds 12 CFR part 390, subpart I in its entirety. This will serve to streamline the FDIC's rules and eliminate unnecessary regulation.

Consistent with the Proposed Rule, the Final Rule also amends the scope of part 343 to include State savings associations and their subsidiaries. The modified scope conforms to and reflects the scope of FDIC's current supervisory responsibilities as the appropriate Federal banking agency for State savings associations. The Final Rule also deletes the definition of “bank” and replaces it with a definition of “FDIC-supervised insured depository institution or institution” defined as “any State nonmember insured bank or State savings association for which the Federal Deposit Insurance Corporation is the appropriate Federal banking agency pursuant to section 3(q) of the Federal Deposit Insurance Act (12 U.S.C. 1813(q)).” As in the Proposed Rule, the Final Rule adds a new subsection (i), which would define “State savings association” as “having the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act (12 U.S.C. 1813(b)(3)).” The Final Rule, as the NPR, transfers an anticoercion and antitying provision that is applicable to State savings associations from part 390, subpart I, to part 343. As in the Proposed Rule, the Final Rule also makes conforming technical edits throughout, including using the term “institution” in place of “bank” throughout the rule where necessary.

In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number.

The Final Rule would rescind and remove from the FDIC regulations part 390, subpart I. Part 390, subpart I was transferred with only nominal changes to the FDIC from the OTS when the OTS was abolished by title III of the Dodd-Frank Act and is substantively similar to the FDIC's existing part 343 regarding consumer protection in the sales of insurance by depository institutions. The information collections contained in part 343 are cleared by OMB under the FDIC's Insurance Sales Consumer Protections information collection (OMB Control No. 3064-0140). The FDIC reviewed its burden estimates for the collection at the time it assumed responsibility for supervision of State savings associations transferred from the OTS and determined that no changes to the burden estimates were necessary. The Final Rule would not revise the Insurance Sales Consumer Protections information collection under OMB Control No. 3064-0140 or create any new information collection pursuant to the PRA. Consequently, no submission will be made to the Office of Management and Budget for review. In the Proposed Rule, the FDIC requested comment on its conclusion that the NPR did not revise the Insurance Sales Consumer Protections information collection 3064-0140. No comments were received.

The Final Rule, as the Proposed Rule, (1) amends part 343 to include State savings associations and their subsidiaries within its scope; and (2) defines “FDIC-supervised insured depository institution or institution” and “State savings association;” (3) transfers an anticoercion and antitying provision from part 390, subpart I, that is applicable to State savings associations to part 343; and (4) makes conforming technical edits throughout. These measures clarify that State savings associations, as well as State nonmember banks, are subject to part 343. With respect to part 343, the Final Rule does not revise any existing, or create any new information collection pursuant to the PRA. Consequently, no submission will be made to the Office of Management and Budget for review. The FDIC requested comment on its conclusion that this aspect of the NPR did not create a new or revise and existing information collection. No comments on this issue were received.

The Regulatory Flexibility Act (“RFA”), requires that, in connection with a final rulemaking, an agency prepare and make available for public comment a final regulatory flexibility analysis that describes the impact of the proposed rule on small entities (defined in regulations promulgated by the Small Business Administration to include banking organizations with total assets of less than or equal to $550 million).28 However, a regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory statement in the Federal Register together with the rule. For the reasons provided below, the FDIC certifies that the Final Rule would not have a significant economic impact on a substantial number of small entities.

As discussed in the NPR, Part 390, subpart I, was transferred to the FDIC from OTS part 536, which governed consumer protections for depository institution sales of insurance. OTS part 536 had been in effect since 2001 and all State savings associations were required to comply with it. Because it is substantially the same as existing part 343 of the FDIC's rules and therefore redundant, the FDIC is rescinding and removing the transferred regulation now located in part 390, subpart I, as proposed in the NPR. As a result, all FDIC-supervised institutions—including State savings associations and their subsidiaries—would be required to comply with part 343 if they are selling, soliciting, advertising, or offering any insurance product. Because all State savings associations and their subsidiaries have been required to comply with substantially similar consumer protection rules if they engaged in sales of insurance since 2001,29 the Final Rule would not place additional requirements or burdens on any State savings association irrespective of its size. Therefore, the Final Rule would not have a significant impact on a substantial number of small entities.

The OMB has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), 5 U.S.C. 801 et seq. As required by SBREFA, the FDIC will submit the Final Rule and other appropriate reports to Congress and the Government Accountability Office for review.

Section 722 of the GLB Act, codified at 12 U.S.C. 4809, requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the NPR, the FDIC invited comments on whether the NPR was clearly stated and effectively organized, and how the FDIC might make it easier to understand. No comments on this issue were received. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.

Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (“EGRPRA”), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions.30 The FDIC, along with the other federal banking agencies, submitted a Joint Report to Congress on March 21, 2017 (“EGRPRA Report”) discussing how the review was conducted, what has been done to date to address regulatory burden, and further measures we will take to address issues that were identified. As noted in the EGRPRA Report, the FDIC is continuing to streamline and clarify its regulations through the OTS rule integration process. By removing outdated or unnecessary regulations, such as part 390, subpart I, and modifying part 343, this rule complements other actions the FDIC has taken, separately and with the other federal banking agencies, to further the EGRPRA mandate.

The Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA) requires the FDIC, in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure or other requirements on insured depository institutions to consider, consistent with the principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, as well as the benefits of such regulations.

In addition, new regulations and amendments to regulations that impose additional reporting, disclosures or other new requirements on insured depository institutions generally must take effect on the first day of the calendar quarter that begins on or after the date on which the regulations are published in final form.31 The Final Rule has no new reporting or other new requirements on insured depository institutions. Therefore, the final rule is not subject to the requirements of the statute.

For the reasons stated in the preamble, the Board of Directors of the Federal Deposit Insurance Corporation is amending 12 CFR parts 343 and 390 as follows:

We use the listings in appendix 1 to subpart P of part 404 of 20 CFR at the third step of the sequential evaluation process to evaluate claims filed by adults and children for benefits based on disability under the title II and title XVI programs.1 20 CFR 404.1520(d), 416.920(d), 416.924(d). The listings are in two parts: Part A has listings criteria for adults and Part B has listings criteria for children. If you are age 18 or over, we apply the listings criteria in Part A when we assess your impairment or combination of impairments. If you are under age 18, we first use the criteria in Part B of the listings when we assess your impairment(s). If the criteria in Part B do not apply, we may use the criteria in Part A when those criteria consider the effects of your impairment(s). 20 CFR 404.1525(b), 416.925(b).

In this final rule, we are extending the dates on which the listings for the following two body systems will no longer be effective as set out in the following chart:

We continue to revise and update the listings on a regular basis, including those body systems not affected by this final rule.2 We intend to update the two listings affected by this final rule as quickly as possible, but may not be able to publish final rules revising these listings by the current expiration dates. Therefore, we are extending the expiration dates listed above.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 in promulgating regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). Generally, the APA requires that an agency provide prior notice and opportunity for public comment before issuing a final regulation. The APA provides exceptions to the notice-and-comment requirements when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest.

We have determined that good cause exists for dispensing with the notice and public comment procedures. 5 U.S.C. 553(b)(B). This final rule only extends the date on which two body system listings will no longer be effective. It makes no substantive changes to our rules. Our current regulations 3 provide that we may extend, revise, or promulgate the body system listings again. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this regulation as a final rule.

In addition, for the reasons cited above, we find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C. 553(d)(3). We are not making any substantive changes to the listings in these body systems. Without an extension of the expiration dates for these listings, we will not have the criteria we need to assess medical impairments in these two body systems at step three of the sequential evaluation processes. We therefore find it is in the public interest to make this final rule effective on the publication date.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the requirements for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB did not review it. We also determined that this final rule meets the plain language requirement of Executive Order 12866.

We certify that this final rule does not have a significant economic impact on a substantial number of small entities because it affects only individuals. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

This final rule does not create any new or affect any existing collections and, therefore, it does not require OMB's approval under the Paperwork Reduction Act.

For the reasons set out in the preamble, we are amending appendix 1 to subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below.

FDA is amending our regulations in 21 CFR parts 890, 900, 1020, and 1040 to correct typographical errors and to update addresses, office titles, and wording to ensure accuracy and clarity in the Agency's medical device regulations.

FDA is making nonsubstantive changes to the following regulations:

1. FDA is revising § 890.5525(b)(2)(i)(A) by replacing “Testing using a drug approved for iontophoretic delivery, or a solution, if identified in the labeling, to demonstrate safe use of the device as intended” with “Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended”.

2. FDA is revising § 900.3(b)(1) by replacing “Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiology Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography Standards Branch” with “Division of Mammography Quality Standards, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993, Attn: Program Management Branch”.

3. FDA is revising § 900.11(b)(2)(i) by replacing “42 U.S.C. 263b(c)(2)” with “42 U.S.C. 263b(c)(4)”.

4. FDA is revising § 1020.30(c) by replacing “Director of the Office of Communication, Education, and Radiation Programs of the Center for Devices and Radiological Health” with “Director, Center for Devices and Radiological Health”.

5. FDA is revising § 1040.10(a)(3)(i) by replacing “Food and Drug Administration, Center for Devices and Radiological Health, Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, Rm. 3521, Silver Spring, MD 20993-0002” with “Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002”.

6. FDA is revising § 1040.10(f)(6)(ii) by replacing “Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health” with “Director, Center for Devices and Radiological Health”.

7. FDA is revising § 1040.10(g)(10) by replacing “Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health” with “Director, Center for Devices and Radiological Health”.

8. FDA is revising § 1040.20(d)(3)(iii) by replacing “Director, Office of Communication, Education, and Radiation Programs 10903 New Hampshire Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993-0002, Center for Devices and Radiological Health” with “Director, Center for Devices and Radiological Health”.

9. FDA is revising § 1040.20(d)(3)(iv) by replacing “manfacturer” with “manufacturer,” and replacing “Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health” with “Director, Center for Devices and Radiological Health”.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 890, 900, 1020, and 1040 are amended as follows:

The Port Authority Trans-Hudson Corporation, the owner of the bridge, requested a temporary deviation from the normal operating schedule to facilitate the replacement of rails and timbers across the length of the span of the bridge. The PATH Bridge across the Hackensack River, mile 3.0, has a vertical clearance in the closed position of 40 feet at mean high water and 45 feet at mean low water. The existing bridge operating regulations are listed at 33 CFR 117.723(b).

Under this temporary deviation, the PATH Bridge shall remain in the closed position between 12:01 a.m. Saturday and 12:01 a.m. Monday as follows: March 31-April 2, 2018; April 7-9, 14-16, 21-23, and 28-30, 2018; May 5-7, 12-14, and 19-21, 2018; June 2-4, 9-11, 16-18, 23-25, and 30-July 2, 2018; July 7-9, 14-16, 21-23, and 28-30, 2018; August 4-6, 11-13, 18-20, and 25-27, 2018; September 8-10, 15-17, 22-24, 2018.

The waterway is transited by commercial and recreational traffic. The Coast Guard notified known companies of the commercial vessels that transit the area, including the Sandy Hook Pilots and the local Tug/Tow Committee; there were no objections to this temporary deviation. Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Seattle Department of Transportation, bridge owner, requested a temporary deviation from the operating schedule for the Fremont Bridge, mile 2.6, and the University Bridge, mile 4.3, both crossing the Lake Washington Ship Canal at Seattle, WA, to facilitate safe passage of participants in the Tenacious Ten run event. The Fremont Bridge provides a vertical clearance of 14 feet (31 feet of vertical clearance for the center 36 horizontal feet) in the closed-to-navigation position. The University Bridge provides a vertical clearance of 30 feet in the closed-to-navigation position. Both bridge clearances are referenced to the mean water elevation of Lake Washington. The normal operating schedule for both the Fremont Bridge and the University Bridge is in 33 CFR 117.1051. During this deviation period, the Fremont Bridge need not open to marine vessels from 8:15 a.m. to 10:15 a.m. on April 21, 2018, and the University Bridge need not open to marine vessel from 8 a.m. to 8:30 a.m. on April 21, 2018. Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft.

Vessels able to pass through the bridges in the closed-to-navigation positions may do so at any time. Both bridges will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), both drawbridges must return to their regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Multnomah County, the bridge owner, has requested a temporary deviation from the operating schedule for the Hawthorne Bridge across the Willamette River, mile 13.1, at Portland, OR. The requested deviation is to accommodate the Walk MS Portland event. To facilitate this event, the draw of the subject bridge will be allowed to remain in the closed-to-navigation position and need not open to marine traffic from 7 a.m. to 11:30 on April 7, 2018. The Hawthorne Bridge provides a vertical clearance of 49 feet in the closed-to-navigation position referenced to the vertical clearance above Columbia River Datum 0.0. The normal operating schedule is in 33 CFR 117.897(c)(3(v). Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. The Coast Guard requested objections to this deviation from local mariners via the Local Notice Mariners, and email. No objections were submitted to the Coast Guard.

Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over the Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position 5 a.m. to 11:30 a.m. on April 8, 2018, to allow the community to participate in the Sactown Run 10 mile and 5K races. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Union Pacific Railroad Company (UPRR) owns and operates the Steel Bridge across the Willamette River, at mile 12.1, in Portland, OR. UPRR has requested a temporary deviation from the operating schedule for the Steel Bridge upper lift span. The deviation is necessary to accommodate the annual Bridge to Brews run event. The Steel Bridge is a double-deck lift bridge, and the lower lift span operates independent of the upper lift span. To facilitate this temporary deviation request, the upper lift span is authorized to remain in the closed-to-navigation position, and need not open to marine vessels from 8:30 a.m. to 10:45 a.m. on April 15, 2018. When the lower span is in the closed-to-navigation position, the bridge provides 26 feet of vertical clearance above Columbia River Datum 0.0. When the upper span is in the closed-to-navigation position, and the lower span is in the open-to-navigation position, the vertical clearance is 71 feet above Columbia River Datum 0.0. The lower lift span of the Steel Bridge operates in accordance with 33 CFR 117.5.

Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass through the subject bridge with the lower deck in the closed-to-navigation position, or in the open-to-navigation position may do so at any time. The lower and upper lift of the Steel Bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard requested objections to this deviation be submitted to the Local Notice to Mariners. We have not received any objections to this temporary deviation from the operating schedule. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the subject bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Throughout this document, “we,” “us” and “our” refer to the EPA.

On January 9, 2018 (83 FR 1001), the EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule based on a determination that it satisfies the applicable CAA requirements. Our proposed action contains more information on the rule and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received one public comment that fails to identify any specific issue that is germane to our action on the rule. The comment letter is available in the docket for this rulemaking.

No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the YSAQMD rule described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we,” “us” and “our” refer to the EPA.

On December 20, 2017, the EPA proposed to approve the following rule and rule rescission into the California SIP (82 FR 60348).

Table 1 lists the rules addressed by this action with the date that they were adopted and repealed by the local air agency, and submitted by the California Air Resources Board (CARB).

We proposed to approve this rule and rule rescission because we determined that they comply with the relevant CAA requirements. Our proposed action contains more information on the rule and rule rescission, and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received seven comments. Commenters generally raised issues that are outside the scope of this rulemaking, including bird and bat deaths associated with wind and solar facilities, the regulation of wildfire risks and emissions from wildfires, and the study of hydraulic fracturing and drinking water. One commenter supported the regulation of emissions from polyester resin operations, and one commenter wrote that “I do not want to repeal the regulations of air pollution.” The EPA notes that it proposed to approve the rescission of SDCAPCD Rule 67.12, while simultaneously proposing to approve its replacement: Rule 67.12.1. The EPA's Technical Support Document, included in the docket for this action, contains the EPA's evaluation, including a SIP relaxation analysis, detailing the EPA's proposed conclusion that the rescission of Rule 67.12 and its replacement with Rule 67.12.1 met the requirements of the Act.

The EPA is required to approve a state submittal if the submittal meets all applicable requirements. 42 U.S.C. 7410(k)(3). The submitted comments either fail to identify any specific issue that is germane to our action, or they do not change our assessment of the SDCAPCD Polyester Resin Operations Rule as described in our proposed action and supporting documents.

No comments were submitted that change our assessment of the rule and rule rescission as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule and rule rescission into the California SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SDCAPCD rule and rule rescission, described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we,” “us” and “our” refer to the EPA.

On December 27, 2017 (82 FR 61203), the EPA proposed to approve the following measure into the California SIP.

We proposed to approve this rule based on a determination that it satisfies the applicable CAA requirements. Our proposed action contains more information on the measure and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received three public comments that fail to identify any specific issue that is germane to our action on the rule. Two of these comments identify issues that are outside of the scope of this rulemaking, including forest management, wildfire suppression, and greenhouse-gas and other emissions from wildfires. The third comment fails to identify any specific issue. The comment letters are available in the docket for this rulemaking.

No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, the EPA is fully approving this rule into the California SIP in accordance with section 110(k)(3) of the Act.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the NSAQMD measure described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

The Northern Kentucky Area was included in the Cincinnati-Hamilton Area, which was originally designated as a moderate nonattainment area for the 1-hour ozone standard on November 6, 1991 (56 FR 56694). In 1995, Kentucky voluntarily opted into the RFG program under Phase I of a two-phase nationwide program to reduce the volatility of commercial gasoline during the summer ozone season. Kentucky elected to stay in the program under Phase II which was more stringent than Phase I.

On July 18, 1997, EPA promulgated a revised 8-hour ozone standard of 0.08 parts per million (ppm). This standard was more stringent than the 1-hour ozone standard. On June 19, 2000 (65 FR 37879), the Cincinnati-Hamilton 1-hour nonattainment Area was redesignated as attainment for the 1-hour ozone NAAQS, and was considered to be a maintenance area subject to a CAA section 175A maintenance plan for the 1-hour ozone NAAQS. On April 30, 2004, EPA designated the Cincinnati-Hamilton OH-KY-IN Area under subpart 1 as a “basic” 1997 8-hour ozone NAAQS nonattainment area (69 FR 23857).1 On August 5, 2010 (75 FR 47218), the Kentucky portion of the Cincinnati-Hamilton 1997 8-hour ozone area was redesignated to attainment.

On March 12, 2008, EPA revised both the primary and secondary NAAQS for ozone to a level of 0.075 ppm to provide increased protection of public health and the environment. See 73 FR 16436 (March 27, 2008). The 2008 ozone NAAQS retains the same general form and averaging time as the 0.08 ppm NAAQS set in 1997, but is set at a more protective level. Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. See 40 CFR 50.15.

Effective July 20, 2012, EPA designated any area that was violating the 2008 8-hour ozone NAAQS based on the three most recent years (2008-2010) of air monitoring data as a nonattainment area. See 77 FR 30088 (May 21, 2012). The Cincinnati-Hamilton, OH-KY-IN Area was designated as a marginal ozone nonattainment area. See 40 CFR 81.318. Areas that were designated as marginal nonattainment areas were required to attain the 2008 8-hour ozone NAAQS as expeditiously as possible but no later than July 20, 2015, based on 2012-2014 monitoring data. On May 4, 2016 (81 FR 26697), EPA published its determination that the Cincinnati-Hamilton, OH-KY-IN Area had attained the 2008 8-hour ozone NAAQS by the attainment deadline.

On August 26, 2016, Kentucky submitted a 2008 8-hour ozone redesignation request and maintenance plan for the Cincinnati-Hamilton Area, which EPA approved on July 5, 2017 (82 FR 30976).2 With its redesignation request, Kentucky included a maintenance demonstration plan that estimated emissions through 2030 that modeled RFG because Kentucky previously opted into the RFG program.

In a September 13, 2017, SIP revision submittal, KDAQ updated the mobile (on-road and non-road) emissions inventory for the August 26, 2016, maintenance plan (including the MVEBs) to reflect Kentucky's petition (see below) to opt-out of the RFG requirements for Boone, Campbell, and Kenton counties in the Northern Kentucky Area. The updates were summarized in KDAQ's submittal. On April 18, 2017, Kentucky's Energy and Environment Cabinet submitted a petition to the EPA Administrator requesting to opt-out of the federal RFG program in the Northern Kentucky Area, and as stated above, the September 13, 2017, SIP revision was submitted in support of that petition (particularly the requirements of 40 CFR 80.72(b)(3) and (4)). Kentucky's opt-out petition will be acted on by the Administrator in a separate action, and if approved in that separate action, will establish the effective date of the opt-out. EPA's RFG regulations require that the opt-out cannot become effective less than 90 days from the effective date of this final action. EPA will also publish a notice in the Federal Register to notify the public of the approval and effective date of the opt-out (See 40 CFR 80.72(c)(7) and (d).)

In a notice of proposed rulemaking (NPRM) published on February 14, 2018 (83 FR 6496), EPA proposed to approve the September 13, 2017, SIP revision. The Agency did not receive any adverse comments on the NPRM.

EPA is approving the changes in the September 13, 2017, SIP revision which includes updating the 2008 maintenance plan 2020 and 2030 MVEBs. The same criteria used to develop the MVEBs in the August 26, 2016, maintenance SIP are used for this SIP revision. The revised MVEBs for nitrogen oxides (NOX) and volatile organic compounds (VOC) are outlined in Table 1 below.

EPA is approving Kentucky's September 13, 2017, SIP revision seeking to revise the maintenance plan emissions inventory and associated MVEBs for years 2020 and 2030 to remove reliance on emissions reductions from the federal RFG program requirements; a program that the Commonwealth voluntarily opted into in 1995. The SIP revision also includes a non-interference demonstration evaluating whether removing reliance on the RFG requirements in the Northern Kentucky Area would interfere with the requirements of the CAA. Within 24 months from this final rule, the transportation partners will need to demonstrate conformity to the new NOX and VOC MVEBs pursuant to 40 CFR 93.104(e)(3). For analysis years 2020 through 2029, the new 2020 MVEBs will be used, and for analysis years 2030 and beyond, the new 2030 MVEBs will be used.

In accordance with 5 U.S.C. 553(d), EPA finds that there is good cause for this action to become effective immediately upon publication. This is because a delayed effective date is unnecessary because this action approves a SIP revision and noninterference demonstration that serves as the basis of a subsequent action to relieve the Area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule grants or recognizes an exemption or relieves a restriction, and section 553(d)(3), which allows an effective date less than 30 days after publication as otherwise provided by the agency for good cause found and published with the rule. The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, this rule will serve as a basis for a subsequent action to relieve the Area from certain CAA requirements. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for this action to become effective on the date of publication of this action.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

I. What actions is EPA taking today?

On February 1, 2017, FDEP submitted to EPA for approval a SIP revision for the purpose of updating Florida's requirements and procedures for emissions monitoring at stationary sources. Florida's February 1, 2017, SIP revision includes amendments to three F.A.C. rule sections and the removal of one F.A.C. rule section from the Florida SIP. Specifically, these changes to Florida's rules include the amendments of Rule 62-297.310, F.A.C.—“General Emissions Test Requirement;” Rule 62-297.440, F.A.C.—“Supplementary Test Procedures;” and Rule 62-297.450, F.A.C.—“EPA VOC Capture Efficiency Test Procedures.” In addition, Florida's February 1, 2017, SIP submittal includes the removal of one of Florida's rule sections from the SIP. Specifically, Florida requested to remove Rule 62-297.401, F.A.C.—“Compliance Test Methods” from the State's implementation plan because it has been repealed at the state level, and, according to the submittal, the section is unnecessary, obsolete or duplicative of other F.A.C. Rules.

Through this rulemaking, EPA is finalizing approval of the portions of Florida's February 1, 2017, SIP revision regarding amendments to Rule 62-297.440, F.A.C., and Rule 62-297.450, F.A.C., as well as the removal of Rules 62-297.401, F.A.C., from the State's implementation plan. The portion of the SIP regarding Rule 62-297.310 was previously approved in a separate rulemaking, which approved several SIP amendments making administrative and recodification changes to Florida's SIP. See 82 FR 46682 (October 6, 2017).

In addition to the removal of Rule 62-297.401, F.A.C., EPA is removing Rule 62-297.400, F.A.C.—“EPA Methods Adopted by Reference” from the Florida SIP. The removal of this rule section was previously approved by EPA, but was never reflected in Florida's SIP-approved rules table in 40 CFR 52.520(c). For more detail on the approval to remove Rule 62-297.400, F.A.C., see the June 16, 1999, rulemaking (64 FR 32346).

On October 13, 2017, EPA published a proposed rulemaking (82 FR 47662), which accompanied a direct final rulemaking (82 FR 47636) published on the same date. The proposed rule proposed to approve the portion of Florida's February 1, 2017 SIP revision described above. It also stated that if EPA received adverse comment on the direct final rule, the direct final rule would be withdrawn and all public comments received would be addressed in a subsequent final rule based on the proposed rule. EPA received 11 comments on the direct final rule, 10 of which were not relevant to the action. However, one of those comments was adverse. As a result, the direct final rule was subsequently withdrawn. After considering the adverse comment, EPA is now taking final action, based on the proposed rule, on the portion of Florida's February 1, 2017 SIP revision described above.

As stated in the proposed rule (82 FR 47662), a detailed rationale for EPA's approval of the above-described portions of Florida's February 1, 2017 SIP revision is set forth in the preamble to the direct final rule (82 FR 47636). In summary, EPA is approving amendments to Rule 62-297.440, F.A.C. that remove several subsections which contain test methods that are either adopted by reference in other rule sections or are now obsolete. EPA is approving amendments to Rule 62-297.450, F.A.C. because the changes clarify and simplify the language in the rule, and are consistent with EPA's VOC capture efficiency test procedure guidelines, as established in the agency's GD-035 guideline. EPA is approving the removal of Rule 62-297.401, F.A.C. from Florida's SIP because the requirements are still in place in other state rules and is unnecessary. Finally, EPA is removing Rule 62-297.400, F.A.C. from Florida's SIP because removal was previously approved by EPA, but was never reflected in Florida's SIP-approved rules table in 40 CFR 52.520(c).

Comment: As mentioned above, EPA received one adverse public comment on the direct final rule published on October 13, 2017. The comment is available for public viewing as a part of the electronic docket for this rulemaking.1 In summary, the Commenter requested EPA to take additional public comments on these SIP revisions because the information in the docket was not fully accessible to the public during the initial comment period for this action. A second portion of the comment was not relevant to the action being taken by EPA.

Response: EPA subsequently made the state submittals and related materials fully accessible to the public in the electronic docket, and on December 14, 2017 (82 FR 58790), reopened the comment period for the proposed rule that accompanied the now withdrawn direct final rule. In the rulemaking reopening the comment period, EPA explained that it would accept public comments until January 16, 2018, and that it would address any comments received in a separate final action based on the proposed action published on October 13, 2017 (82 FR 47662). During the reopened comment period from December 14, 2017, until January 16, 2018, EPA received an additional 12 comments, but those comments were not relevant. The 12 additional comments are included in the electronic docket for this action.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Rule 62-297.440, F.A.C., entitled “Supplementary Test Procedures” and Rule 62-297.450, F.A.C., entitled “EPA VOC Capture Efficiency Test Procedures,” both state effective on July 19, 2014. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally-enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.2

EPA is finalizing approval of the above mentioned changes to the Florida SIP, as submitted to us in Florida's February 1, 2017, SIP revision. Specifically, EPA is approving the amendments to Rule 62-297.440, F.A.C., and Rule 62-297.450, F.A.C., both state effective on July 19, 2014, as well as the removal of Rule 62-297.401, F.A.C., from Florida's SIP. In addition, EPA is removing Rule 62-297.400, F.A.C., from Florida's SIP as approved in a previous rulemaking.3 This action is limited to the two rule revisions and two rule removals mentioned above and does not act on the portion of the February 1, 2017, SIP submittal regarding Rule 62-297.310. As mentioned in Section I above, the changes to Rule 62-297.310, were previously approved in a separate rulemaking. See 82 FR 46682 (October 6, 2017).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under Section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See Section 307(b)(2).

40 CFR part 52 is amended as follows:

Sections 111(d) and 129 of the CAA require states to submit plans to control certain pollutants (designated pollutants) at existing solid waste combustor facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines (EG) for such existing sources. CAA section 129 directs EPA to establish standards of performance for new sources and emissions guidelines for existing sources for each category of solid waste incineration unit. CAA section 129(a) and (b). According to section 129(a)(4) of the CAA, EPA also must specify numerical emissions limitations for particulate matter (total and fine), opacity (as appropriate), sulfur dioxide, hydrogen chloride, oxides of nitrogen, carbon monoxide, lead, cadmium, mercury, and dioxins and dibenzofurans.

If a state fails to submit a satisfactory plan, the CAA provides EPA the authority to prescribe a plan for regulating the designated pollutants at the designated facilities. EPA prescribed plan, also known as a federal plan, is often delegated to states with designated facilities but no EPA approved state-specific plan. If no such designated facilities exist within a state's jurisdiction, a state may submit to the EPA a letter of certification to that effect (referred to as a negative declaration) in lieu of a state plan to satisfy the state's obligation. 40 CFR 60.23(b) and 62.06. A negative declaration exempts the state from the requirement to submit a CAA section 111(d)/section 129 plan for that designated pollutant and source category. 40 CFR 60.23(b).

The Maryland Department of the Environment (MDE) has determined that there are no existing CISWI units subject to the requirements of sections 111(d) and 129 of the CAA in its respective air pollution control jurisdiction. Accordingly, MDE submitted a negative declaration letter to EPA certifying this fact on January 20, 2017. A notice of proposed rulemaking was published in the Federal Register on February 1, 2018 (83 FR 4621). EPA received three comments during the public comment that were not specific nor related to this action and thus are not addressed here. The negative declaration letter and EPA's notice of proposed rulemaking are available in the docket for this rulemaking and online at www.regulations.gov.

In this final action, EPA is approving the negative declaration for CISWI units submitted by MDE on January 20, 2017 and amending part 62 to reflect receipt of the negative declaration and subsequent approval by EPA. EPA is accepting the negative declaration in accordance with the requirements of the CAA and 40 CFR 60.23(b) and 62.06.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely notifies the public of EPA receipt of a negative declaration from an air pollution control agency without any existing CISWI units in their jurisdiction. This action imposes no requirements. Accordingly, EPA certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This action also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves the negative declaration for existing CISWI units from the MDE and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This action also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

With regard to negative declarations for designated facilities received by EPA from states, EPA's role is to notify the public of the receipt of such negative declarations and revise 40 CFR part 62 accordingly. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to approve or disapprove a CAA section 111(d)/129 plan negative declaration submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a CAA section 111(d)/129 negative declaration, to use VCS in place of a section 111(d)/129 negative declaration that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving the negative declaration for existing CISWI units within the State of Maryland may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 62 is amended as follows: