Comments Invited

We invite you to send us any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2009-0331; Directorate Identifier 2008-NE-40-AD” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of the Web site, anyone can find and read the comments in any of our dockets, including, if provided, the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is the same as the Mail address provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

On April 6, 2009, we issued a proposal to amend part 39 of the Code of Federal Regulations (14 CFR part 39) to add an AD, for Honeywell International Inc. TFE731 series turbofan engines with certain second stage LPCR discs and/or certain third stage LPCR discs installed. The proposed AD published as an NPRM in the Federal Register on April 13, 2009 (74 FR 16807). That NPRM proposed to require removing from service, certain second and third stage LPCR discs, P/Ns 3072396-1, 3072397-1, 3075109-1, or 2075192-1.

Since we issued that NPRM, we became aware that LPCR disc P/N 2075192-1 is incorrect. We changed the AD to the correct disc P/N of 3075192-1.

We also became aware that the NPRM compliance is unclear in that it describes the affected parts as “second and third stage LPCR disc”. To clarify, we changed the description to “a second stage LPCR disc and/or a third stage LPCR disc.” We also changed the applicability statement from “* * * turbofan engines with certain low-pressure compressor rotor (LPCR) discs, part numbers (P/Ns) 3072396-1, 3072397-1, 3075190-1, or 2075192-1, installed” to “turbofan engines with certain second stage low-pressure compressor rotor (LPCR) discs, part number (P/N) 3072396-1 or 3075190-1, and/or certain third stage LPCR discs, P/N 3072397-1 or 3075192-1, installed.” Because we are making these corrections, this supplemental NPRM reopens the comment period.

As we stated in the original proposed AD, we received a report of cracks found during an FPI of the disc bore. This condition, if not corrected, could result in an uncontained failure of a second stage LPCR disc and/or third stage LPCR disc due to cracks in the bore, which could result in damage to the airplane.

We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other products of this same type design. We are proposing this AD, which would require removing from service engines with second stage LPCR discs and/or third stage LPCR discs that have a S/N:

• In Table 5 of ASBs TFE731-72-A3748, dated August 21, 2008, or TFE731-72-A3749, dated August 21, 2008, within 100 cycles-in-service (CIS) after the effective date of this proposed AD, and

• In Table 6 of ASBs TFE731-72-A3748, dated August 21, 2008, or TFE731-72-A3749, dated August 21, 2008, within 2,000 CIS or the next access after the effective date of this proposed AD, whichever occurs first.

The proposed AD would require you to use the service information described previously to perform these actions.

We estimate that this supplemental proposed AD would affect 27 engines installed on airplanes of U.S. registry. We also estimate that it would take about 4 work-hours per engine to perform the proposed actions during scheduled maintenance and 140 work-hours per engine for the proposed actions during unscheduled maintenance. The average labor rate is $80 per work-hour. Required parts would cost about $31,000 per engine. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators to be $900,000.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

Under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2009-1166; Directorate Identifier 2009-NM-107-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2009-0111, dated May 13, 2009 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Airbus has issued Mandatory Service Bulletin A300-27-0201, including Appendices 1, 2, and 3, dated March 9, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Paragraph (f)(4) of this NPRM specifies to return certain THSA units to the manufacturer. These parts must be returned to the manufacturer so that it can investigate the root cause of the identified unsafe condition. In addition, for certain findings, only the manufacturer can repair/overhaul the unit.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect about 12 products of U.S. registry. We also estimate that it would take about 5 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $4,800, or $400 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

In the Federal Register of October 1, 2009 (74 FR 50744), FDA published a proposed rule with a 90-day comment period to request comments on postmarketing safety reporting requirements for combination products. Comments on the proposed rule will inform FDA's rulemaking to establish regulations for postmarketing safety reporting for combination products.

The agency has received requests for a 30-day extension of the comment period for the proposed rule. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the requests and is extending the comment period for the proposed rule for 30 days, until January 29, 2010. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

This proposed rule is necessary to implement the Veterans' Benefits Improvement Act of 2008, Public Law 110-389, 122 Stat. 4145, 4147. Section 101(a)(1) of the Act redesignated former 38 U.S.C. 5103(a) as 38 U.S.C. 5103(a)(1) but made no change to its language. 122 Stat. 4147. Section 5103(a)(1) continues to require VA to notify a claimant for veterans benefits of the information and evidence not previously provided to the Department that is necessary to substantiate a claim and of the respective responsibilities of VA and the claimant in obtaining various portions of the evidence. The United States Court of Appeals for the Federal Circuit (Federal Circuit) has held that section 5103(a)(1) “on its face does not address the level of required detail” in the notice provided and “must be interpreted as requiring only generic notice at the outset.” Wilson v. Mansfield, 506 F.3d 1055, 1059-60 (Fed. Cir. 2007). The Federal Circuit explained that “generic notice”, refers to notice that “identif[ies] the information and evidence necessary to substantiate the particular type of claim being asserted” by a claimant. Id. In Angel Vazquez-Flores v. Eric K. Shinseki, Secretary of Veterans Affairs, and Michael R. Schultz v. Eric K. Shinseki, Secretary of Veterans Affairs, Nos. 2008-7150 & 2008-7115, 2009 WL 2835434, *6 (Fed. Cir. Sept. 4, 2009), the Federal Circuit stated that the term “particular type of claim” refers to the type of claim filed, e.g., claim for service connection or an increased rating. See also Wilson, 506 F.3d at 1059-60; Paralyzed Veterans of Am. v. Secretary of Veterans Affairs, 345 F.3d 1334, 1347 (Fed. Cir. 2003).

Section 101(a)(2) of Public Law 110-389 amends 38 U.S.C. 5103(a) by adding subsection (a)(2), requiring the Secretary of Veterans Affairs to prescribe in regulations requirements relating to the content of notice to be provided under section 5103(a). VA's regulations must specify “different contents” for notice based on the type of claim filed (e.g., original claims, reopened claims, claims for increase), must provide that the contents of the notice be appropriate to the type of benefits or services sought under the claim, and must specify the “general information and evidence required to substantiate the basic elements” of each type of claim. Public Law 110-389, 122 Stat. 4147. Section 101(b) of Public Law 110-389, 112 Stat. 4147, specifies that the regulations will apply to notice provided to claimants on or after the effective date of such regulations. However, the statute does not specify the types of “information and evidence” that would be required for any type of claim, nor does it limit VA's authority to determine what types of information and evidence are necessary for that purpose.

VA is proposing to amend current 38 CFR 3.159 so that it would pertain only to VA's duty to notify a claimant upon receipt of an application for veterans benefits, as required by 38 U.S.C. 5102 and 5103. Therefore, § 3.159(a)(1) and (2), (c), (d), (e), (f), and (g), which pertain to VA's duty to assist in developing claims under 38 U.S.C. 5103A, rather that the duty to notify under section 5103, would be redesignated as new § 3.167(a) through (e). We have made one substantive amendment to current § 3.159(d)(3) which will be redesignated as new § 3.167(c)(1). We are eliminating lack of veteran status as a basis upon which VA will refrain from or discontinue assistance under section 5103A in new section 3.167(c)(1) because the United States Court of Appeals for Veterans Claims (Veterans Court) held in Gardner v. Shinseki, 22 Vet. App. 415, 421 (2009), that VA has a duty to assist a person who files a claim for veterans benefits alleging that he or she is a veteran even if the person has not demonstrated veteran status.

VA provides the following assistance to develop a claimant's status as a veteran. Sections III through V of VA Form 21-526, Veteran's Application for Compensation and/or Pension, ask a veteran to provide information about his or her military service and to attach an original or certified copy of the claimant's DD214, Certification of Release or Discharge from Active Duty. As part of the initial screening process, VA conducts a routine check of the application and accompanying documents to determine whether the claimant has provided sufficient information to verify the character of discharge from military service and the claimed service. If the information provided is not sufficient to verify the claimed service or to establish the claimant's status as a “veteran,” VA assists the claimant by requesting military records and other relevant records, as explained in § 3.167(b)(1)-(3) of this rulemaking, which is a recodification of current § 3.159(c)(1)-(3). VA discontinues its assistance if the Department determines that the claimant's service does not satisfy the requirements of title 38, United States Code, or the claimant does not submit essential information missing from the application that VA has requested. Also, VA will not provide assistance if no reasonable possibility exists that such assistance would aid in substantiating the claimant's status as a veteran, e.g., the claimant's DD214 shows that the claimant received a dishonorable discharge from service.

Current § 3.159(a)(4) defines “event” for purposes of current § 3.159(c)(4)(ii), which pertains to VA's duty to assist. However, the term is also relevant with regard to the notice VA must provide regarding the elements necessary to substantiate a claim for service connection. We are therefore retaining the definition without substantive amendment as new § 3.159(a)(5) and also redesignating it without substantive amendment as proposed new § 3.167(a)(3).

In addition to current § 3.159(a)(4), VA would retain in amended § 3.159 another definition in current § 3.159(a) that pertains to VA's duty to notify. The current definition of “[s]ubstantially complete application” in § 3.159(a)(3) would be redesignated in new § 3.159(a)(1) and we would additionally define the term to include an application “identifying” pertinent information. Proposed new § 3.159(a)(2) would define “[T]ype of claim filed” to mean “an original claim, claim to reopen a prior final decision on a claim, or a claim for increase in benefits.” This regulatory definition incorporates 38 U.S.C. 5103(a)(2)(B)(i) identifying “an original claim, claim for reopening a prior decision on a claim, [and] a claim for an increase in benefits” as the three types of claims for which VA must specify different contents.

VA would state in § 3.159(a)(3) that “[t]ype of benefit sought” refers to “the general nature of the benefits sought, such as disability compensation, increased compensation, dependency and indemnity compensation, and pension.” The definition would not include “specific disabilities, theories of entitlement, or other case-specific facts.” Section 5103(a)(1) itself makes clear that the requisite notice must be provided soon after VA receives the complete or substantially complete application. At the juncture in the claims process at which VA must comply with 38 U.S.C. 5103(a)(1), VA is unable to provide notice that accounts for specific disabilities, theories of entitlement, or particular facts. VA solicits case-specific information and evidence by sending development letters to claimants as part of the Department's duty to assist in obtaining evidence to substantiate claims as required by 38 U.S.C. 5103A.

VA would redesignate without change the definition of “[i]nformation” in current § 3.159(a)(5) as proposed new § 3.159(a)(4).

VA would redesignate without substantive amendment current § 3.159(f) as proposed new § 3.159(b), which would state that, for purposes of the notice requirements in §§ 3.159 through 3.166, notice to the claimant means notice to the claimant or his or her fiduciary, if any, as well as to his or her representative, if any.

VA would redesignate without amendment current § 3.159(b)(2) as proposed new § 3.159(c), describing the notice that VA would provide upon receipt of an incomplete application.

Proposed new § 3.159(d) would address the notice VA would provide upon receipt of a complete or substantially complete application, as required by 38 U.S.C. 5103(a)(1). Proposed new § 3.159(d)(1) describes the purpose of the notice required by 38 U.S.C. 5103(a)(1). Consistent with the plain language of 38 U.S.C. 5103(a)(1), which is unchanged by Public Law 110-389 and section 101(a)(2) of the Act, § 3.159(d)(1) would explain that, upon receipt of a complete or substantially complete application, VA “will provide a claimant with notice of the general information and types of evidence that could be used by VA in deciding the type of claim filed for the type of benefit sought.” The first and second sentences of this paragraph would generally restate 38 U.S.C. 5103(a)(2)(B)(ii) and (iii).

The third sentence of proposed § 3.159(d)(1) would state that “VA generally will not * * * identify specific evidence necessary to substantiate an individual claimant's case.” As the Federal Circuit explained in Vazquez-Flores, 38 U.S.C. 5103(a)(1) does not require veteran-specific notice. 2009 WL 2835434, *6; see also Wilson, 506 F.3d at 1059-60. In addition, because VA provides notice under section 5103(a) at an early stage in the claim, VA can provide notice of the general types of evidence that would be needed to substantiate the claim for the type of benefit sought, but generally cannot at that stage identify specific items of evidence that may prove necessary in each individual case once the facts and arguments have been developed pursuant to VA's duty to assist. Further, any attempt to identify specific items of evidence would not only be potentially speculative, but would often require highly detailed and complex notice to account for the variety of facts and arguments that may be raised as the claim is developed.

The report of the Senate Veterans' Affairs Committee on S. 3023, which was enacted as Public Law 110-389, noted that IBM Global Business Services found “the current [VA notice] letter to be `long and complex, containing a great deal of legal language that can be confusing to veterans when trying to understand the process for completing their disability claim.' ” S. Rep. 110-449, at 8-9 (2008). IBM recommended that VA revise the notice letter “to be shorter and more transparent,” a conclusion that the Senate committee appeared to endorse. Id. at 9-10. VA formed a work group and, consistent with the recommendations, VA revised notice letters provided to claimants for compensation, pension, and death benefits to make the letters shorter and more specific. We believe that VA notice will be more easily read and understood by claimants if VA provides short, succinct notice about the information and evidence necessary to substantiate the type of claim filed and benefit sought at the initial stages of a claim and defers case-specific letters to the development stage of the claim. Id. at 78 (letter from Secretary of Veterans Affairs James B. Peake, M.D., dated July 8, 2008). VA currently receives more than 800,000 claims annually, most of which require VA to provide section 5103(a)(1) notice. Id. By providing generic rather than case-specific notice, the Department is able to respond quickly to a claimant's application for benefits, thereby commencing the claims-adjudication process. Id. Case-specific notice, by contrast, is not administratively feasible and would only delay the process without appreciably furthering development of the information and evidence necessary to substantiate the claim.

Consistent with proposed new § 3.159(d)(1), we would explain in the proposed new § 3.159(d)(2)(i) that VA will notify a claimant of the general type of information and evidence that is necessary to substantiate entitlement for the type of veterans benefits for which a claim was filed. Vazquez-Flores, 2009 WL 2835434, *6; Wilson, 506 F.3d at 1058-60.

Proposed new § 3.159(d)(2)(ii) and (iii) would explain how VA's notice will delineate the parties' respective obligations under 38 U.S.C. 5103(a)(1) to obtain the information or evidence necessary to substantiate a claim. As set forth in § 3.159(d)(2)(ii), VA will notify a claimant that VA will obtain records that a claimant adequately identifies and authorizes VA to obtain from any Federal agency or from any other entity or person and will provide a medical examination or obtain a medical opinion if necessary to decide the claim.

Proposed new § 3.159(d)(2)(i)(A) and (B) would state that VA will notify a claimant of the claimant's obligation to provide VA with enough information to identify and locate the records, including the person or entity holding the records, the approximate time frame covered by the records, and, in the case of medical-treatment records, the condition for which treatment was provided and, if necessary, to authorize the release to VA of existing records in a form acceptable to the person or entity holding the records.

Proposed new § 3.159(d)(3) would explain the circumstances under which VA will not provide notice under 38 U.S.C. 5301(a)(1). This is a restatement of current § 3.159(b)(3), with one additional circumstance. In proposed new § 3.159(d)(3)(i), we would state that VA will not provide notice if the claim can be granted when the initial application is filed. In such cases, there is no need to delay award of the benefit by issuing notice and waiting at least 30 days for a response from the claimant because VA already has the information and evidence necessary to grant the claim.

Proposed new § 3.159(d)(4) would provide the time period within which a claimant must provide the information and evidence requested by VA. Proposed new § 3.159(d)(4)(i) and (ii) would redesignate the last three sentences of current § 3.159(b)(1).

We propose to redesignate current §§ 3.160 and 3.161 as §§ 3.170 and 3.171 respectively.

Proposed new § 3.160 would provide the content of the notice that VA will provide upon receipt of an original claim for disability compensation. Paragraph (a)(1) would explain that, if a veteran alleges disability resulting from active duty, VA will notify the veteran that information and evidence of the following is necessary to substantiate the claim: (1) A current disability, which is established by medical treatment records, medical opinions, and evidence from non-medical persons about persistent and recurrent symptoms of disability they have observed; (2) inservice incurrence or aggravation of an injury or disease, symptoms that were noted during service and that persisted until diagnosis of an injury or disease causing the symptoms, or an event in service capable of causing injury or disease, which is established by medical treatment records, medical opinions, and, in the case of certain symptoms or inservice events, evidence from non-medical persons; and (3) a relationship between the inservice disease, injury, symptoms, or event and the veteran's current disability, which is generally established by medical treatment records, medical opinions, or by use of a legal presumption that the disability is related to a particular type of military service, such as detention as a prisoner of war, participation in a radiation-risk activity, or service in Vietnam or the Southwest Asia theater of operations during the Gulf War. Subsection (a)(1) would also explain that information and evidence must show the extent of current disability, which may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran's ability to work and from other people about how the veteran's symptoms affect the veteran.

VA would not provide notice of the information and evidence necessary to establish the claimant's status as a veteran. VA Form 21-526, Veteran's Application for Compensation and/or Pension, solicits from a veteran information that enables VA to verify the veteran's service and character of discharge, and, under its duty to assist with claim development, VA requests the records necessary to verify the veteran's service and character of discharge from the military service departments. “ `Service department findings are binding on VA for purposes of establishing service in the U.S. Armed Forces.' ” Spencer v. West, 13 Vet. App. 376, 380 (2000) (quoting Duro v. Derwinski, 2 Vet. App. 530, 532 (1992)); 38 CFR 3.203. Therefore, in most cases, there is no need to notify a claimant of the information and evidence necessary to substantiate veteran status and VA instead tailors the notice provided to the type of benefit sought.

VA also would not provide notice regarding the information and evidence necessary to substantiate an effective date for an award of benefits. We recognize that the Veterans Court has held that VA must provide notice under 38 U.S.C. 5103(a)(1) as to all elements of a claim, including “downstream elements” such as establishing entitlement to an effective date. Dingess v. Nicholson, 19 Vet. App. 473, 484 (2006), aff'd per curiam, Nos. 2006-7247 & 2006-7312, 2007 WL 1686737 (Fed. Cir. June 5, 2007). However, we believe that, at the initial stage of a claim when section 5103(a)(1) notice must be provided, notice of the information and evidence necessary to establish an effective date for an award of benefits “may be misleading and confusing” to the claimant. S. Rep. 110-449, at 10. For example, it may lead the claimant to assume that service connection has been conceded and that the issue on which evidence must be submitted relates to the effective date. Id.

Further, there is generally no need to notify claimants of the need to submit evidence relating to the effective dates of VA awards. The determination of an effective date of an award is governed by statute and there generally is no evidence that a claimant can submit to substantiate a particular effective date. Pursuant to 38 U.S.C. 5110, the effective date of an award in most circumstances is based upon the date of the claim for benefits, the date of separation from service, the date of a veteran's death, or the date a disability arose or worsened. The date of the claim will be a matter of record before VA sends notice under section 5103(a)(1). The other events upon which an effective date may be based generally will be established by the same evidence that VA obtains or requests the claimant to submit for purposes of establishing entitlement to the benefit sought. As noted above, VA routinely obtains verification of service from the service department, as needed, upon receipt of a complete application providing the necessary information. Further, at the time VA grants disability or death benefits and the issue of effective date therefore arises, VA will necessarily have obtained, pursuant to its notice under section 5103(a)(1) and its duty to assist under section 5103A, evidence documenting the date of the veteran's death (in death benefit claims) or medical evidence concerning the diagnosis, treatment, and history of the veteran's disability (in disability benefit cases). There will seldom be circumstances where additional evidence would be relevant with respect to the issue of effective date. However, in the event that additional evidence would be relevant at the stage of proceedings in which VA assigns an effective date, it may be addressed in the notices relevant to that stage of proceedings, including notices of decisions and statements of the case.

As explained in § 3.160(a)(2), VA will notify a claimant who files a claim alleging disability based on active duty for training that information and evidence of the following is necessary to show service connection for the disability: (1) A current disability, which is established by medical treatment records, medical opinions, and evidence from non-medical persons about persistent and recurrent symptoms of disability they have observed; (2) disability during active duty for training from a disease or injury that was incurred or aggravated in line of duty, symptoms that were noted during active duty for training and that persisted until diagnosis of an injury or disease causing the symptoms, or an event during such training capable of causing injury or disease, which is generally established by medical treatment records, medical opinions and competent non-medical evidence based on personal observations; and (3) a relationship between the current disability and the disability suffered during active duty for training, which is generally established by medical treatment records or medical opinions. Subsection (a)(2) would also explain that the information and evidence must show the extent of the claimant's current disability, which may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the claimant's ability to work and from other people about how the claimant's symptoms affect the claimant.

Section 3.160(a)(3) would state that VA will notify a claimant who files a claim based on inactive duty training that the following information and evidence is necessary to substantiate the claim: (1) A current disability, which is established by medical treatment records, medical opinions, and evidence from non-medical persons about persistent and recurrent symptoms of disability they have observed; (2) disability during inactive duty training from an injury that was incurred or aggravated during such training or an acute myocardial infarction, cardiac arrest, or cerebrovascular accident during such training, which is generally established by medical treatment records or medical opinions; and (3) a relationship between the claimant's current disability and the disability suffered during inactive duty training. Subsection (a)(3) would also explain that the information and evidence must show the extent of current disability, which may be based on medical treatment records, medical opinions, statements from the claimant's employer about how the disability affects the claimant's ability to work and from other people about how the claimant's symptoms affect the claimant.

Section 3.160(b) would explain that, if a veteran files a claim alleging disability caused or aggravated by a service-connected disability, VA will notify the veteran that information and evidence of the following is necessary to substantiate the claim: (1) The veteran has a disability in addition to the service-connected disability, which is established by medical treatment records, medical opinions, and evidence from non-medical persons about persistent and recurrent symptoms of disability they have observed; (2) a relationship between the additional disability and a service-connected disability, which is generally established by medical treatment records and medical opinions; and (3) the extent of current disability, which may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran's ability to work and from other people about how the veteran's symptoms affect the veteran.

Section 3.160(c) would describe the notice that VA will provide upon receipt of an application for disability caused by VA treatment, vocational rehabilitation, or compensated work therapy. Section 3.160(c) would explain that VA will notify the veteran that information and evidence of the following is necessary to substantiate the claim: (1) An additional physical or mental disability or an aggravation of an existing injury or disease, which is established by medical treatment records, medical opinions, and evidence from non-medical persons about persistent and recurrent symptoms of disability they have observed; (2) the veteran's additional disability or aggravation of an existing injury or disease was caused by VA hospital care, medical or surgical treatment or examination, VA training or rehabilitation services, or participation in VA's compensated work therapy program, which is generally established by medical treatment records and medical opinions; (3) the additional disability or aggravation caused by VA hospital care, medical or surgical treatment or examination was the direct result of VA fault (carelessness, negligence, lack of proper skill, or error in judgment) or was the direct result of an event not reasonably foreseeable (i.e., not an ordinary risk of the services provided); and (4) the extent of current additional disability, which may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran's ability to work and from other people about how the veteran's symptoms affect the veteran.

Section 3.161 would explain the notice that VA will provide upon receipt of an application seeking increased disability compensation. Section 3.161(a) would state that VA will notify a claimant the following information and evidence is necessary to substantiate a claim for an increased schedular rating: (1) An increase in the extent of the claimant's service-connected disability, which is based on medical treatment records, medical opinions, and statements from non-medical persons about persistent and recurrent symptoms of disability they have observed; and (2) the extent of current disability, which may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran's ability to work and from other people about how the veteran's symptoms affect the veteran. VA will notify a claimant that VA will assign a rating for the disability from 0 to 100 percent under the VA Schedule for Rating Disabilities.

Consistent with proposed new § 3.159(d)(1), VA will not provide case-specific notice in increased-rating claims regarding the relevant rating criteria under diagnostic codes (DC) that are applicable to rating the current extent of a claimant's disability for the following reasons. First, as the Federal Circuit has explained, 38 U.S.C. 5103(a)(1) is satisfied by generic notice regarding an increased-rating claim rather than veteran-specific notice regarding the DCs applicable to a particular veteran's claim. Vazquez-Flores, 2009 WL 2835434, *6, *10; Wilson, 506 F.3d at 1059-60; Paralyzed Veterans, 345 F.3d at 1347. We note as well that section 101(a) of the Veterans' Benefits Improvement Act of 2008 retained section 5103(a) as subsection (a)(1) and made no amendment to the provision. Thus, the unamended text of 38 U.S.C. 5103(a)(1) does not require that VA provide case-specific notice of potentially applicable DCs.

Second, notifying the claimant to submit evidence that their disability has increased in severity generally will put the claimant on notice to submit or direct VA's attention to all evidence that potentially may bear upon the severity of the disability. Third, many provisions in VA's rating schedule necessarily contain detailed medical criteria that would not be useful to claimants. A notice conveying extensive and often technical regulatory criteria will likely be long and complex, containing a great deal of medical language that can be confusing for the average reader, thereby diminishing its usefulness. See S. Rep. 110-449, at 8-9. Generic notice, on the other hand, will be more readily understandable and useful to claimants. Id. at 78. Fourth, it is VA's policy to assign a rating under the DC that most closely reflects the features of the current disability as shown by the medical evidence. This may require consideration of several potentially applicable DCs containing different criteria. Providing notice of the criteria under a single DC, such as that previously used in a particular case, may be misleading and may dissuade claimants from submitting all evidence bearing upon the current severity of their disabilities. At the same time, a notice conveying the requirements of several potentially applicable DCs, many of which may ultimately prove inapplicable upon development of the claim, may be confusing the claimant and may create unrealistic expectations. Fifth, providing notice tailored to the specific DCs potentially applicable to each claim requires time-consuming review in each case by VA employees in order to identify potentially applicable DCs based on the facts previously of record. The time devoted to such review would divert resources from the development and adjudication of claims and, for the reasons stated above, generally would not make VA's notices more helpful to claimants. By providing generic notice, VA will be able to focus its resources on adjudicating the more than 800,000 claims filed annually. Id.

We recognize that the Senate Veterans' Affairs Committee report on Public Law 110-389 urges VA to codify in regulations the holding of Vazquez-Flores v. Peake, 22 Vet. App. 91 (2008), vacated, No. 2008-7150, 2009 WL 2835434 (Fed. Cir. Sept. 4, 2009), in which the Veterans Court held that 38 U.S.C. 5103(a)(1) requires VA to provide case-specific notice in increased-rating claims regarding the relevant DC criteria applicable to a claim. S. Rep. 110-449, at 11-12. However, VA believes, and the Federal Circuit concurs, that the Veterans Court's interpretation of section 5103(a)(1) does not accurately reflect the plain language of the statute and does not appropriately defer to VA's interpretation of the statute as reflected in former 38 CFR 3.159(b). Vazquez-Flores, 2009 WL 2835434, *6. In accordance with the provisions of Public Law 110-389 directing VA to prescribe regulations governing the content of VA notices under section 5103(a)(1), we propose to clarify our interpretation of the statute, consistent with the Federal Circuit's guidance in Vazquez-Flores and Wilson. With all due respect to the views expressed in the Committee report, such statements do not carry the force of law, particularly where they do not illuminate the meaning of the statutory terms, but merely express expectations that were not themselves reflected in the statute as passed. See Strickland v. Commissioner, Maine Dep't of Human Servs., 48 F.3d 12, 19 (1st Cir. 1995). We note that there was no mention of Vazquez-Flores during deliberations by the House of Representatives on Public Law 110-389. 154 Cong. Rec. H9387-H9405 (daily ed. Sept. 24, 2008). It is well established that expressions of expectations in isolated committee reports do not have the force of law, nor do they express the intent of Congress. See Strickland, 48 F.3d at 19 (declining to rely on legislative history comprised of “one paragraph in one report of one of the two chambers that passed the law”); Scalise v. Thornburgh, 891 F.2d 640, 645 (7th Cir. 1989) (“An expression of an `expectation' by one committee of the House * * * does not establish congressional intent”); cf. Lincoln v. Vigil, 508 U.S. 182, 193 (1993) (“Congress may always circumscribe agency discretion to allocate resources by putting restrictions in the operative statutes (though not * * * just in the legislative history).”). In addition, section 101(b) of Public Law 110-389 authorizes the Secretary of Veterans Affairs to prescribe regulations regarding the content of the notices that the Department will provide. The fact that Public Law 110-389 itself contains no language circumscribing in any way the Secretary's discretion to promulgate such regulations also leads us to conclude the “expectation” expressed in the Senate Committee report is not dispositive as to the notice that VA must provide upon receipt of a claim for an increased rating.

Section 3.161(b) explains the notice that VA would provide upon receipt of an application for a rating of total disability based on individual unemployability. The notice would state that the information and evidence generally must establish that a veteran is unable to secure and follow substantial gainful employment because of a service-connected disability rated at least 60 percent disabling or more than one service-connected disability with one disability rated at 40 percent or more and a combined rating of at least 70 percent, but that VA will consider all evidence showing that the veteran is unemployable even if these ratings are not met. This determination may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran and the veteran's ability to work, and statements from other people about how the veteran's symptoms affect the veteran.

Section 3.161(c) would state that VA will notify a claimant that, to substantiate a claim for temporary total disability due to hospitalization, the information and evidence must show that the veteran was hospitalized for treatment for a service-connected disability in a VA hospital or an approved hospital for more than 21 days or was hospitalized for observation for a service-connected disability at VA expense for more than 21 days. This is based on medical treatment records.

Section 3.161(d) would state that VA would notify a claimant that to substantiate a claim for temporary total disability due to surgery or other treatment the information and evidence must show that the veteran received surgery at a VA or other approved hospital or outpatient facility for a service-connected disability and that the surgery required convalescence for at least 1 month or resulted in severe postoperative residuals (such as incompletely healed surgical wounds, stumps of recent amputations, therapeutic immobilizations, house confinement, or required use of a wheelchair or crutches), or that the veteran received treatment at a VA or other approved hospital or outpatient facility that resulted in immobilization by cast, without surgery, of at least one major joint. This is based on medical treatment records.

Section 3.161(e) would state that VA would notify a claimant that to substantiate a claim for increased compensation because of the need for aid and attendance or bedridden status, medical treatment records, medical opinions, and competent non-medical evidence based on personal observations must show that the veteran requires the aid of another person to perform personal functions required in everyday living, such as bathing, feeding, or adjustment of prosthetics, or must remain in bed due to his or her disability or disabilities based on medical necessity and not based on a prescription of bed rest for purposes of convalescence or cure. VA also requires medical treatment records and medical reports showing that the veteran's need for aid and attendance or confinement to bed is a result of a service-connected disability.

In § 3.161(f), VA would state that, upon receipt of a claim for increased compensation based on being permanently housebound, VA will notify the claimant that the information and evidence must show that the veteran has a totally disabling service-connected disability. This may be based on medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran's ability to work, and statements from other people about how the veteran's symptoms affect the veteran. The information and evidence must also show that the veteran is substantially confined to the veteran's house, ward or clinical areas if institutionalized, or immediate premises due to a service-connected disability or disabilities. This is established by medical treatment records, medical opinions, and statements from non-medical people about how the disability affects the veteran and the veteran's ability to function.

Section 3.162 would explain the notice that VA would provide when a veteran files a claim for improved pension or increased pension. Section 3.162(a) would state that, if VA receives a claim for improved pension, VA will notify the claimant that the information and evidence must show the veteran served during a period of war.

In addition, VA will notify the claimant that the information and evidence must show that the veteran is 65 years of age or older, or alternatively, that the veteran is permanently and totally disabled due to a nonservice-connected disability, which means that the veteran is a patient in a nursing home for long-term care, receiving social security disability benefits; unemployable due to a disability reasonably certain to continue through the veteran's lifetime; or suffering from a disability that is reasonably certain to continue through the veteran's lifetime and would make it impossible for the average person to follow a substantially gainful occupation; or suffering from a disease or disorder that VA believes justifies a determination that people who have the disease or disorder are permanently and totally disabled. This may be established by Social Security Administration records or medical treatment records, medical opinions, statements from the veteran's employer about how the disability affects the veteran and the veteran's ability to work, and statements from other people about how the veteran's symptoms affect the veteran. VA will also notify the claimant that the information and evidence must show that the claimant's annual income and net worth do not exceed certain limits.

For reasons similar to those explained above concerning proposed § 3.160, we do not propose to provide notice of the criteria governing effective dates as part of the notice under section 5103(a)(1). By statute, the effective date of pension awards generally will be governed by the date of the application or by other facts that would necessarily be established by the evidence upon which the pension award is based. There ordinarily would be no other evidence relating solely to effective dates that would be necessary to substantiate a claim. However, in the event that additional evidence would be relevant in a particular case at the stage of proceedings in which VA assigns an effective date, it may be addressed in the notices relevant to that stage of proceedings.

Section 3.162(b) would explain the notice that VA will provide upon receipt of a claim for increased pension. VA will notify the claimant that medical treatment records, medical opinions, and competent non-medical evidence based on personal observations must show that the claimant is in need of regular aid and attendance or is permanently housebound or, alternatively, the information and evidence must show that there has been a change in the claimant's income or net worth. A claimant is in need of regular aid and attendance if the claimant: (1) Has 5/200 visual acuity or less in both eyes; (2) has concentric contraction of the visual field to 5 degrees or less in both eyes; (3) is a patient in a nursing home because of mental or physical incapacity; or (4) requires the aid of another person in order to perform personal functions of everyday living, such as bathing, feeding, or adjusting a prosthetic device. A claimant is permanently housebound if the claimant is substantially confined to the claimant's house or immediate premises, or ward or clinical areas if institutionalized, because of a disability or disabilities and it is reasonably certain that the disability or disabilities will not improve during the claimant's lifetime.

Section 3.163 would explain the notice that VA will provide upon receipt of a claim for benefits from a veteran's survivor. In addition to notice regarding the type of claim filed by a veteran's survivor, VA will also notify the claimant of the information and evidence necessary to substantiate a claim for accrued benefits because the claimant may be entitled to benefits that were due and unpaid the veteran at death.

As set forth in § 3.163(a)(1), VA will notify a survivor who files a claim for dependency and indemnity compensation (DIC) based on a death related to active duty that the information and evidence must show that: (1) The veteran died during active duty; (2) VA awarded the veteran service connection for a disease or injury and medical evidence shows that the disease or injury caused or contributed to the veteran's death; or (3) the veteran had a disease or injury that was incurred or aggravated during active duty or was caused by an event during active duty, as shown by medical evidence, competent non-medical evidence based on personal observations, and use of applicable legal presumptions, and medical evidence shows that the disease or injury caused or contributed to the veteran's death.

We recognize that, in Hupp v. Nicholson, 21 Vet. App. 342, 352-53 (2007), the Veterans Court held that notice in the context of a DIC claim “must include (1) A statement of the conditions, if any, for which a veteran was service connected at the time of his or [her] death; (2) an explanation of the evidence and information required to substantiate a DIC claim based on a previously service-connected condition; and (3) an explanation of the evidence and information required to substantiate a DIC claim based on a condition not yet service-connected.” The proposed rule would include the latter two components, but not the first. As explained above, the Federal Circuit stated in Vazquez-Flores, 2009 WL 2835434, *6, *10, and Wilson, 506 F.3d at 1059, 1062, that the language in current section 5103(a)(1) requires generic notice tailored to the type of claim filed rather than veteran-specific notice. The notice required by Hupp, which was decided before Vazquez-Flores and Wilson, is not generic but rather would entail a review of the veteran's claim file to determine whether VA previously granted service connection for a veteran's disability.

In VA's judgment and experience, the generic notice described in § 3.163(a) would explain to a claimant the information and evidence necessary to substantiate a DIC claim based on a previously service-connected disability as well as a claim based on a disability that was not previously service connected. DIC claimants are members of the veteran's immediate family and generally will know or can easily determine whether the veteran was granted service connection for any conditions. Moreover, VA will already have that information and will consider it in developing and deciding the claim. DIC claimants will not need to submit evidence of such awards. Additionally, the fact that VA previously awarded the veteran service connection for certain conditions would not preclude a DIC claimant from establishing service connection for a different condition that caused the veteran's death. Recitation of the veteran's previously service-connected conditions, which may have no bearing upon the DIC claim, is not necessary in order to notify the claimant of the information and evidence VA needs to substantiate the claim. Requiring such notices tailored to the specific facts of each DIC claim would impose unnecessary burdens and delays in VA's claim processing.

Section 3.163(a)(2) would explain that VA will notify a survivor who files a claim for DIC based on a death related to active duty for training that the information and evidence must show one of the following: (1) That the veteran died during active duty for training; (2) that VA had granted the veteran service connection for a disease or injury and medical evidence shows that the service-connected disease or injury caused or contributed to the veteran's death; or (3) that the veteran was disabled during active duty for training due to a disease or injury incurred in the line of duty, as shown by medical evidence and competent non-medical evidence based on personal observation, and medical evidence shows that the disease or injury caused or contributed to the veteran's death.

Section 3.163(a)(3) would explain that VA will notify a survivor who files a claim for DIC based on a death related to inactive duty training that the information and evidence must show that the veteran: (1) Died during inactive duty training due to an injury incurred or aggravated in line of duty or an acute myocardial infarction, cardiac arrest or cerebrovascular accident during such training, as shown by medical evidence and competent non-medical evidence based on personal observations; or (2) had a disability that was due to an injury incurred or aggravated during inactive duty training or an acute myocardial infarction, cardiac arrest, or cerebrovascular accident during such training, as shown by medical evidence and competent non-medical evidence based on personal observations, and medical evidence shows that the injury, acute myocardial infarction, cardiac arrest, or cerebrovascular accident caused or contributed to the veteran's death.

Section 3.163(a)(4) would explain that VA will notify a survivor who files a claim for DIC that, if the veteran did not die from a service-connected disability, DIC is payable if the veteran was receiving compensation from VA for a service-connected disability that was rated totally disabling. The veteran must have received, or been entitled to receive, compensation for at least 10 years immediately before death; at least 5 years immediately preceding death and continuously since the veteran's release from active duty; or at least 1 year immediately preceding death, if the veteran was a former prisoner of war who died after September 30, 1999.

Section 3.163(a)(5) would set forth the notice that VA would provide upon receipt of a claim for DIC based upon a veteran's death caused by VA treatment, vocational rehabilitation or compensated work therapy. VA would notify the claimant that generally the medical treatment records and medical opinions must show that the veteran's death was caused by VA hospital care, medical or surgical treatment or examination, VA training or rehabilitation services, or participation in VA's compensated work therapy program. The evidence also must show that veteran's death, which was caused by VA hospital care, medical or surgical treatment or examination, was the direct result of VA fault (carelessness, negligence, lack of proper skill, or error in judgment) or was the direct result of an event not reasonably foreseeable (i.e., not an ordinary risk of the services provided). VA would notify the claimant that this requirement does not apply to claims based on VA training or rehabilitation services or compensated work therapy.

In § 3.163(b), VA would explain the notice that will be provided upon receipt of a claim for supplemental DIC for a veteran's child or parent. Section 3.163(b)(1) would state that, upon the receipt of a claim for supplemental DIC for a veteran's child, VA will provide notice that medical treatment records and medical opinions must show that the child, before his or her 18th birthday, became permanently incapable of self-support due to a mental or physical disability.

Section 3.163(b)(2) would state that, upon receipt of a claim for supplemental DIC for a veteran's parent, VA will provide notice that medical treatment records and medical opinions must show that the parent has corrected visual acuity of 5/200 or less, in both eyes, or concentric contraction of the visual field to 5 degrees or less; or is a patient in a nursing home because of mental or physical incapacity; or requires the aid of another person in order to perform personal functions required in everyday living, such as bathing, feeding, and dressing.

Section 3.163(c) would explain that, when VA receives a claim for improved pension from a veteran's surviving spouse or child, VA will notify the claimant that the information and evidence must show that the veteran served: (1) For ninety days or more during a period of war; (2) for ninety consecutive days, at least one of which was during a period of war; (3) for any length of time during a period of war and was discharged or released for a service-connected disability; or (4) for any length of time during a period of war and at the time of death was receiving or was entitled to receive VA compensation or service department retirement pay for a service-connected disability. The notice would further explain that the information and evidence must show that the claimant's annual income and net worth do not exceed certain limits.

Section 3.163(d) would explain that, when VA receives a claim for increased pension from a veteran's surviving spouse, VA would provide notice that to substantiate the claim, medical treatment records, medical opinions, and competent non-medical evidence based on personal observations must show that the claimant is in need of regular aid and attendance or permanently housebound and would provide notice of the criteria for establishing need for regular aid and attendance or permanent housebound status. The notice would explain that a claimant is in need of regular aid and attendance if the claimant: (1) Has 5/200 visual acuity or less in both eyes; (2) has concentric contraction of the visual field to 5 degrees or less in both eyes; (3) is a patient in a nursing home because of mental or physical incapacity; or (4) requires the aid of another person in order to perform personal functions of everyday living, such as bathing, feeding, or adjusting a prosthetic device. The notice would further explain that a claimant is permanently housebound if the claimant is substantially confined to the claimant's house or immediate premises because of a disability or disabilities and it is reasonably certain that the disability or disabilities will not improve during the claimant's lifetime.

Section 3.163(e) would explain that, when VA receives a claim for accrued benefits and survivor benefits, VA would provide notice that to substantiate a claim for accrued benefits, the information and evidence must show that the benefits were awarded to the individual by a VA rating or decision before the individual died, or evidence in VA's possession on or before the date of the individual's death, even if such evidence was not physically located in the VA claims folder on or before the date of death, shows that the individual had applied for and was entitled to the benefits. VA would also notify the claimant that accrued benefits are paid to the following persons in the following order of priority: (1) Veteran's surviving spouse; (2) veteran's children (in equal shares); and (3) veteran's surviving dependent parents (in equal shares) or the surviving dependent parent if only one is living.

Proposed new § 3.164 would explain the notice that VA will provide upon receipt of an application for specially adapted housing, special home adaptation grant, allowance for an automobile or automobile adaptive equipment, clothing allowance, and monetary allowances for certain children provided under chapter 18 of title 38, United States Code.

Section 3.164(a) would explain that, upon receipt of an application for specially adapted housing, VA would notify the claimant that medical treatment records and medical opinions must show that the veteran or servicemember on active duty is permanently and totally disabled due to one of the following: (1) Loss, or loss of use, of both lower extremities requiring the use of braces, crutches, canes, or a wheelchair to move from place to place; (2) blindness in both eyes so that the veteran can see only light, together with the loss, or loss of use of one lower extremity; (3) loss, or loss of use, of one lower extremity, together with a disease or injury that affects the veteran's balance or ability to move forward and requires the use of braces, crutches, canes, or a wheelchair in order to move from place to place; (4) loss, or loss of use, of one lower extremity, together with loss or loss of use of one upper extremity that affects the veteran's balance or ability to move forward and requires the use of braces, crutches, canes, or a wheelchair in order to move from place to place; (5) loss, or loss of use, of both upper extremities that prevents the veteran from using the arms at or above the elbows; or (6) severe burn injury. The notice would further explain that the information and evidence must show that the veteran or servicemember suffered the disability as a result of an injury, disease, or event in line of duty in the active military, naval or air service, or as the result of VA hospital care, medical or surgical treatment or examination under circumstances involving VA carelessness, negligence, lack of proper skill or error in judgment or an event not reasonably foreseeable, or as the result of VA training or rehabilitation services or participation in VA's compensated work therapy program.

Section 3.164(b) would explain that upon receipt of a claim for a special home adaptation grant, VA would notify the claimant that medical treatment records and medical opinions must show that the veteran or servicemember on active duty is permanently and totally disabled due to a service-connected disability resulting from blindness in both eyes with 5/200 visual acuity or less; anatomical loss or loss of use of both hands; or severe burn injury. The notice would further explain that the information and evidence must establish that the veteran or servicemember suffered the disability as a result of an injury, disease, or event in line of duty in the active military, naval or air service, or as the result of VA hospital care, medical or surgical treatment or examination under circumstances involving VA carelessness, negligence, lack of proper skill or error in judgment or an event not reasonably foreseeable, or as the result of VA training or rehabilitation services or participation in VA's compensated work therapy program.

Section 3.164(c) would explain the notice that VA would give a claimant for an automobile allowance and/or adaptive equipment. VA would notify a claimant for an automobile allowance and adaptive equipment that medical treatment records and medical opinions must show that a veteran is entitled to compensation as a result of, or a servicemember on active duty is disabled due to the loss, or permanent loss of use, of at least a foot or a hand or permanent impairment of vision in both eyes, resulting in vision of 20/200 or less in the better eye with glasses or vision of 20/200 or better, if there is a severe defect in peripheral vision. The notice would further explain that the information and evidence must establish that the veteran or servicemember suffered the disability as a result of an injury, disease, or event in line of duty in the active military, naval or air service, or as a result of VA hospital care, medical or surgical treatment or examination under circumstances involving VA carelessness, negligence, lack of proper skill or error in judgment or an event not reasonably foreseeable, or as a result of VA training or rehabilitation services or participation in VA's compensated work therapy program.

Further, VA would notify a claimant for adaptive equipment that such a claim may also be substantiated by information and evidence showing that a veteran is entitled to compensation for ankylosis of at least one knee or one hip. The information and evidence must show that the veteran suffered the disability as a result of an injury, disease, or event in line of duty in the active military, naval or air service, or as a result of VA hospital care, medical or surgical treatment or examination under circumstances involving VA carelessness, negligence, lack of proper skill or error in judgment or an event not reasonably foreseeable, or as a result of VA training or rehabilitation services or participation in VA's compensated work therapy program.

Section 3.164(d) would explain the notice that VA will provide upon receipt of an application for a clothing allowance. VA would notify a claimant that the information and evidence must show that the veteran suffered a disability as a result of an injury, disease, or event in line of duty in the active military, naval or air service, or as a result of VA hospital care, medical or surgical treatment or examination under circumstances involving VA carelessness, negligence, lack of proper skill or error in judgment or an event not reasonably foreseeable, or as a result of VA training or rehabilitation services or participation in VA's compensated work therapy program. VA would also notify the claimant that a VA examination or hospital report or an examination report from a government or private facility must show that the veteran wears or uses a prosthetic or orthopedic appliance because the qualifying disability tends to wear out or tear the veteran's clothes, or the veteran uses prescription medication for a skin condition which is due to a qualifying disability and the medication causes irreparable damage to the veteran's outer garments.

Section 3.164(e) would explain the notice that VA will provide upon receipt of an application for a monetary allowance for an individual with spina bifida born to a Vietnam veteran. VA will notify a claimant that the information and evidence must show that: (1) The individual's biological father or mother is or was a veteran who performed active military, naval, or air service in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975, including service in the waters offshore and service in other locations if the conditions of service involved duty or visitation in the Republic of Vietnam, and (2) the individual was conceived on or after the date on which the veteran first served in the Republic of Vietnam. VA would notify the claimant that this is based on evidence such as service department records and a birth certificate, church record of baptism, affidavit or certified statement from a physician or midwife present during the birth, or notarized copy of a Bible or other family record containing reference to the birth and medical treatment records and medical opinions showing that the individual has any form or manifestation of spina bifida except spina bifida occulta.

VA would also notify the claimant that VA will examine the nature and severity of the individual's disability due to spina bifida and assign an evaluation of Level 1 to Level 3 by comparing the individual's symptoms to the criteria in § 3.814 of title 38, Code of Federal Regulations, and that this is based on medical treatment records and reports and statements from the individual's employer and other people about how the disability affects the individual's ability to work and function.

Section 3.164(f) would explain the notice that VA will provide upon receipt of an application for a monetary allowance for an individual with certain birth defects born to a female Vietnam veteran. VA will notify a claimant that the information and evidence must show that: (1) The individual's biological mother is or was a veteran who performed active military, naval, or air service in the Republic of Vietnam during the period beginning on February 28, 1961, and ending on May 7, 1975, including service in the waters offshore and service in other locations if the conditions of service involved duty or visitation in the Republic of Vietnam; and (2) the individual was conceived on or after the date on which the veteran first served in the Republic of Vietnam. VA would notify the claimant that this is based on evidence such as service department records and a birth certificate, church record of baptism, affidavit or certified statement from a physician or midwife present during the birth, or notarized copy of a Bible or other family record containing reference to the birth and medical treatment records and medical opinions showing that the individual has a covered birth defect.

VA would also notify the claimant that VA will examine the nature and severity of the individual's disability to the birth defect(s) and assign an evaluation of Level 1 to Level 3 by comparing the individual's symptoms to the criteria in § 3.815 of title 38, Code of Federal Regulations, and that this is based on medical treatment records and reports and statements from the individual's employer and other people about how the disability affects the individual's ability to work and function.

Proposed new § 3.165 would explain the notice that VA will provide upon receipt of an application to reopen a previously denied claim based on new and material evidence. In Kent v. Nicholson, 20 Vet. App. 1, 9 (2006), the Veterans Court stated that “VA must inform a claimant seeking to reopen a previously and finally disallowed claim of the unique character of evidence that must be presented” because “[t]he terms `new' and `material' have specific, technical meanings that are not commonly known to VA claimants.” Therefore, in addition to the notice described in §§ 3.160 through 3.164 regarding the type of benefit sought, VA will notify a claimant that “new” and “material” evidence is evidence not previously submitted to VA, that by itself or when considered with previous evidence of record, relates to an unestablished fact necessary to substantiate the claim and raises a reasonable possibility of substantiating the claim. However, we recognize that the Veterans Court also stated in Kent, 20 Vet. App. at 10, that, upon receipt of a claim to reopen, VA must “look at the bases for the denial in the prior decision and * * * [provide] a notice letter that describe[s] what evidence would be necessary to substantiate th[e] element or elements * * * that were found insufficient in the previous denial.” This holding in Kent, which requires VA to provide case-specific notice upon receipt of a claim to reopen, is inconsistent with the subsequent Federal Circuit decisions in Vazquez-Flores and Wilson, holding that section 5103(a)(1) is satisfied by “generic notice,” i.e., notice that “identif[ies] the information and evidence necessary to substantiate the particular type of claim being asserted” by a claimant and rejecting the argument that the statute requires specific notice of missing evidence with respect to a particular claim. 2009 WL 2835434, *6, *10; 506 F.3d at 1059-60. VA will therefore not provide such case-specific notice to a claimant who has filed an application to reopen a previously denied claim. Pursuant to 38 U.S.C. 5104(b) and 7104(d)(1), if VA denies a claim, it must provide the claimant a written statement of the reasons for the denial and of the evidence considered. Accordingly, the type of notice to be provided under proposed § 3.165 will be sufficient to inform claimants as to the types of evidence needed to reopen a claim in view of the information previously provided to the claimants.

In allowing VA to provide generic rather than case-specific notice upon receipt of a claim to reopen, proposed new § 3.165 would promote the efficiency of the veterans' benefit adjudication process. VA currently receives approximately 800,000 claims annually, most of which require VA to provide notice under 38 U.S.C. 5103(a)(1). The type of notice that would be provided by VA upon receipt of a claim to reopen would allow the Department to respond quickly with notice that is easily understood by a claimant. The type of notice required by the Veterans Court in Kent, by contrast, imposes administrative burdens that, in VA's view, are not required by section 5103(a)(1) and that would result in undue delays in VA claims processing.

We explain in § 3.166 that VA will provide notice of the evidence and information necessary to substantiate a claim for any other benefit governed by part 3 of title 38, Code of Federal Regulations, consistent with the statutory and regulatory eligibility criteria for the benefit sought.

This document contains no provisions constituting a new collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined and it has been determined to be a significant regulatory action under Executive Order 12866 because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The Secretary hereby certifies that this proposed regulatory amendment would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This proposed amendment would not directly affect any small entities. Only individuals could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this proposed amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance numbers and titles for this program are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses, and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability, and 64.110, Veterans Dependency and Indemnity Compensation for Service Connected Death.

For the reasons set forth in the preamble, VA proposes to amend 38 CFR part 3, subpart A, as follows:

1. Confidential Business Information. Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number). Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

Essential use allowances are allowances to produce or import certain ozone depleting substances (ODSs) in the U.S. for purposes that have been deemed “essential” by the U.S. Government and by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol).

The Montreal Protocol is the international agreement aimed at reducing and eliminating the production and consumption 1 of ODSs. The elimination of production and consumption of Class I ODSs is accomplished through adherence to phaseout schedules for specific Class I ODSs,2 which include CFCs, halons, carbon tetrachloride, and methyl chloroform. As of January 1, 1996, production and import of most Class I ODSs were phased out in developed countries, including the United States.

However, the Montreal Protocol and the Clean Air Act (the Act) provide exemptions that allow for the continued import and/or production of Class I ODSs for specific uses. Under the Montreal Protocol, exemptions may be granted for uses that are determined by the Parties to be “essential.” Decision IV/25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality. The criteria for an essential use, as set forth in paragraph 1 of Decision IV/25, are the following:

Title VI of the Act implements the Montreal Protocol for the United States.3 Section 604(d) of the Act authorizes EPA to allow the production of limited quantities of Class I ODSs after the phaseout date for the following essential uses:

(1) Methyl Chloroform, “solely for use in essential applications (such as nondestructive testing for metal fatigue and corrosion of existing airplane engines and airplane parts susceptible to metal fatigue) for which no safe and effective substitute is available.” Under section 604(d)(1) of the Act, this exemption was available only until January 1, 2005. Prior to that date, EPA issued methyl chloroform allowances to the U.S. Space Shuttle and Titan Rocket programs.

(2) Medical devices (as defined in section 601(8) of the Act), “if such authorization is determined by the Commissioner [of the Food and Drug Administration], in consultation with the Administrator [of EPA] to be necessary for use in medical devices.” EPA issues allowances to manufacturers of MDIs that use CFCs as propellant for the treatment of asthma and chronic obstructive pulmonary disease.

(3) Aviation safety, for which limited quantities of halon-1211, halon-1301, and halon-2402 may be produced “if the Administrator of the Federal Aviation Administration, in consultation with the Administrator [of EPA] determines that no safe and effective substitute has been developed and that such authorization is necessary for aviation safety purposes.” Neither EPA nor the Parties have ever granted a request for essential use allowances for halon, because alternatives are available or because existing quantities of this substance are large enough to provide for any needs for which alternatives have not yet been developed.

An additional essential use exemption under the Montreal Protocol, as agreed in Decision X/19, is the general exemption for laboratory and analytical uses. This exemption is reflected in EPA's regulations at 40 CFR part 82, subpart A. While the Act does not specifically provide for this exemption, EPA has determined that an exemption for essential laboratory and analytical uses is allowable under the Act as a de minimis exemption. The de minimis exemption is addressed in EPA's final rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol subsequently agreed (Decision XI/15) that the general exemption does not apply to the following uses: testing of oil and grease, and total petroleum hydrocarbons in water; testing of tar in road-paving materials; and forensic finger-printing. EPA incorporated this exemption at Appendix G to Subpart A of 40 CFR part 82 on February 11, 2002 (67 FR 6352). In a December 29, 2005, final rule, EPA extended the general exemption for laboratory and analytical uses through December 31, 2007 (70 FR 77048), in accordance with Decision XV/8 of the Parties to the Protocol. At the 19th Meeting of the Parties in September 2007, the Parties agreed to extend the global laboratory and analytical use exemption through December 31, 2011, in Decision XIX/18. In a December 27, 2007, final rulemaking EPA took action to (1) extend the laboratory and analytical use exemption from December 31, 2007, to December 31, 2011, for specific laboratory uses, (2) apply the laboratory and analytical use exemption to the production and import of methyl bromide, and (3) eliminate the testing of organic matter in coal from the laboratory and analytical use exemption (72 FR 73264).

The procedure set out by Decision IV/25 calls for individual Parties to nominate essential uses and the total amount of ODSs needed for those essential uses on an annual basis. The Protocol's Technology and Economic Assessment Panel (TEAP) evaluates the nominated essential uses and makes recommendations to the Parties. The Parties make the final decisions on whether to approve a Party's essential use nomination at their annual meeting. This nomination process occurs approximately two years before the year in which the allowances would be in effect. The allowances proposed for allocation for 2010 were first nominated by the United States in January 2008.

For MDIs, EPA requests information from manufacturers about the number and type of MDIs they plan to produce, as well as the amount of CFCs necessary for production. EPA then forwards the information to the Food and Drug Administration (FDA), which determines the amount of CFCs necessary for MDIs in the coming calendar year. Based on FDA's determination, EPA proposes allocations to each eligible entity. Under the Act and the Montreal Protocol, EPA may allocate essential use allowances in quantities that together are below or equal to the total amount approved by the Parties. EPA will not allocate essential use allowances in amounts higher than the total approved by the Parties. For 2010, the Parties authorized the United States to allocate up to 92 MT of CFCs for essential uses.

The following is a step-by-step list of actions EPA and FDA have taken thus far to implement the exemption for medical devices found at section 604(d)(2) of the Act for the 2010 calendar year.

1. On January 7, 2009, EPA sent letters to MDI manufacturers requesting the following information under section 114 of the Act (“114 letters”):

a. The MDI product where CFCs will be used.

b. The number of units of each MDI product produced from 1/1/08 to 12/31/08.

c. The number of units anticipated to be produced in 2009.

d. The number of units anticipated to be produced in 2010.

e. The gross target fill weight per unit (grams).

f. Total amount of CFCs to be contained in the MDI product for 2010.

g. The additional amount of CFCs necessary for production.

h. The total CFC request per MDI product for 2010.

2. At the end of January 2009, as required by 40 CFR 82.13(u), EPA received information from MDI manufacturers that included such data as the type and quantity of CFCs held at the end of the year (i.e. stocks of pre-1996 and post-1996 CFCs). The data submitted from the MDI manufacturers is available for review in the Air Docket ID No. EPA-HQ-OAR-2009-0566. The companies requested that their individual responses be treated as confidential business information; for this reason, EPA has placed the individual responses in the confidential portion of the docket.

3. On April 1, 2009, EPA sent FDA the information MDI manufacturers provided in response to the 114 letters and information required by 40 CFR 82.13(u) with a letter requesting that FDA make a determination regarding the amount of CFCs necessary for MDIs for calendar year 2010. This letter is available for review in Air Docket ID No. EPA-HQ-OAR-2009-0566.

4. On July 10, 2009, FDA sent a letter to EPA stating the amount of CFCs determined by the Commissioner to be necessary for each MDI company in 2010. This letter is available for review in the Air Docket ID No. EPA-HQ-OAR-2009-0566. FDA's letter informed EPA that it had determined that 30.0 MT of CFCs were necessary for use in medical devices in the year 2010.

With respect to the 2010 determination, FDA stated, “Our determination for the allocation of CFCs is lower than the total amount requested by manufacturers. In reaching this estimate, we took into account the sponsors' production of MDIs that used CFCs as a propellant in 2008, their estimated production in 2009, their estimated production in 2010, their anticipated essential-use allocations in 2009, and their current (as of December 31, 2008) stockpile levels. Our determination took into account any transferred CFCs as well as pre-1996 CFC amounts. Finally, we based our determination for 2010 on an estimate of the quantity of CFCs that would allow manufacturers to have adequate stockpiles at the end of 2010 consistent with the principles in paragraph 3 of Decision XVI/12 and paragraph 2 of Decision XVII/5.”

The letter stated that in making its determination, FDA made the following assumptions:

• All manufacturers will receive the full essential-use allocation proposed by EPA for calendar year 2009 (74 FR 2954, January 16, 2009);

• All manufacturers will procure the full quantity of CFCs allocated to them for 2009; and

• No bulk CFCs currently held by, or allocated to, any manufacturer will be exported from the United States.

EPA has confirmed with FDA that this determination is consistent with Decision XVII/5, including language on stocks that states that Parties “shall take into account pre- and post-1996 stocks of controlled substances as described in paragraph 1(b) of Decision IV/25, such that no more than a one-year operational supply is maintained by that manufacturer.” Allowing manufacturers to maintain up to a one-year operational supply accounts for unexpected variability in the demand for MDI products or other unexpected occurrences in the market and therefore ensures that MDI manufacturers are able to produce their essential use MDIs.

In accordance with the FDA determination, today's action proposes to allocate essential use allowances for a total of 30.0 MT of CFCs for use in MDIs for calendar year 2010.

The amounts listed in this proposal are subject to additional review and revision by EPA and FDA if information demonstrates that the proposed allocations are either too high or too low. We specifically request comment on the extent to which the proposed allocation of CFCs is sufficient to protect public health and ensure the manufacture and continuous availability of CFCs necessary to meet the expected demand. We also request comment on whether the proposed allocation, when considered along with current stocks, will best protect consumers by providing a smooth transition to non-CFC alternatives. Commenters requesting increases or decreases of essential use allowances should provide detailed information supporting a claim for additional or fewer CFCs. Any company that needs less than the full amount listed in this proposal should notify EPA of the actual amount needed.

EPA proposes to allocate essential use allowances for calendar year 2010 to the entity listed in Table I. These allowances are for the production or import of the specified quantity of Class I controlled substances solely for the specified essential use.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it raises novel legal or policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.

EPA prepared an analysis of the potential costs and benefits related to this action. This analysis is contained in the Agency's Regulatory Impact Analysis (RIA) for the entire Title VI phaseout program (U.S. Environmental Protection Agency, “Regulatory Impact Analysis: Compliance with Section 604 of the Clean Air Act for the Phaseout of Ozone Depleting Chemicals,” July 1992). A copy of the analysis is available in the docket for this action and the analysis is briefly summarized here. The RIA examined the projected economic costs of a complete phaseout of consumption of ozone-depleting substances, as well as the projected benefits of phased reductions in total emissions of CFCs and other ozone-depleting substances, including essential use CFCs used for MDIs.

This action does not impose any new information collection burden. The recordkeeping and reporting requirements included in this action are already included in an existing information collection burden and this action does not propose any changes that would affect the burden. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations at 40 CFR 82.8(a) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0170. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impact of today's proposed rule on small entities, small entity is defined as: (1) A small business that is primarily engaged in pharmaceutical preparations manufacturing as defined by NAICS code 325412 with less than 750 employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant its field.

After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 USC 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

This proposed action will provide an otherwise unavailable benefit to those companies that are receiving essential use allowances by creating an exemption to the regulatory phaseout of chlorofluorocarbons. We have therefore concluded that today's proposed rule will relieve regulatory burden for all small entities. We continue to be interested in the potential impact of the proposed rule on small entities and welcome comments on issues related to such impacts.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. The action imposes no enforceable duty on any State, local or tribal governments or the private sector. This action does not impose any new requirements on any entities. Therefore, this action is not subject to the requirements of sections 202 and 205 of the UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments because this rule merely allocates essential use allowances to entities under an exemption to the ban on production and import of Class I ODSs.

This action does not have federalism implications. It will 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. This action merely allocates essential use allowances to entities under an exemption to the ban on production and import of Class I ODSs. Thus, Executive Order 13132 does not apply to this rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed action from State and local officials.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action merely allocates essential use allowances to entities under an exemption to the ban on production and import of Class I ODSs. This action does not impose substantial direct compliance costs on Indian tribal governments. Thus, Executive Order 13175 does not apply to this action. EPA specifically solicits additional comment on this proposed action from tribal officials.

EPA interprets EO 13045 as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This proposed rule is not subject to EO 13045 because it implements Section 604(d)(2) of the Clean Air Act which states that the Agency shall authorize essential use exemptions should the Food and Drug Administration determine that such exemptions are necessary.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action merely allocates essential use allowances to entities under an exemption to the ban on production and import of Class I ODSs.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rule does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has concluded that it is not practicable to determine whether there would be disproportionately high and adverse human health or environmental effects on minority and/or low income populations from this proposed rule. EPA believes, however, that this action affects the level of environmental protection equally for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. Any ozone depletion that results from this proposed rule will impact all affected populations equally because ozone depletion is a global environmental problem with environmental and human effects that are, in general, equally distributed across geographical regions.

40 CFR part 82 is proposed to be amended as follows:

I. Overview of Proposed Revisions to the Guidelines for National Standard 2

Section 301(a)(2) of the MSA specifies that fishery conservation and management measures shall be based upon the best scientific information available. Section 301(b) of the MSA states that “the Secretary (of Commerce) shall establish advisory guidelines (which shall not have the force and effect of law), based on national standards, to assist in the development of fishery management plans.” The existing national standard guidelines appear at 50 CFR 600.310 through 600.355. The Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) of 2006 included provisions to improve the use of science in decisionmaking, provide a stronger role for Councils' SSCs, and establish an optional peer review process for scientific information used to advise Councils about conservation and management of fisheries. Therefore, NMFS is proposing revisions to the NS2 guidelines to address these MSA provisions and provide guidance and recommendations on peer review processes. NMFS published an advanced notice of proposed rulemaking (ANPR) in the Federal Register on September 18, 2008 (73 FR 54132). NMFS has carefully considered the public comments received in developing this proposed rule.

In 2004, the National Research Council (NRC) of the National Academies examined the application of the BSIA standard in the development of fishery conservation and management measures. The NRC recommended approaches to more uniformly apply the BSIA standard for current and future fishery management actions. The NRC recommendations are available in the NRC (2004) publication entitled “Improving the Use of the `Best Scientific Information Available' Standard in Fisheries Management” (2004, http://books.nap.edu/openbook.php).

NMFS proposes that the 2004 NRC recommendations regarding the use of BSIA for fishery management should be incorporated to the extent possible in this proposed revision to the NS2 guidance. The ANPR comments provided a nearly unanimous recommendation that the NS2 guidelines be revised to incorporate the NRC recommendations, and that an overly prescriptive definition of BSIA should be avoided due to the dynamic nature of science. Therefore, as recommended by the NRC, the proposed NS2 guideline revisions are based on the following widely accepted principles for evaluating BSIA: Relevance, inclusiveness, objectivity, transparency, timeliness, verification, validation, and peer review of fishery management information as appropriate. NMFS also agrees with the comments that the NS2 guidelines should not prescribe a static definition of BSIA because of the dynamic developments inherent in making improvements in scientific information for fishery management.

The availability of scientific information to inform fisheries management varies. Ecosystems and human societies are complex, interacting, dynamic systems that are impacted by multiple factors, including those within the scope of fisheries management. Some fisheries are well studied and have much information from long-term annual research surveys and comprehensive biological, social, and economic fisheries data collection programs. Other fisheries do not have the same breadth of information available. In light of this variability, the proposed NS2 guideline revisions elevate the importance of evaluating the uncertainty and associated risk of the scientific information used to help inform fishery management decisions.

Similarly, the time available to review scientific information and the importance of that information to fishery management decisions are also variable. As a general rule, substantial management alternatives considered by a Council should be peer reviewed, but in some cases, formal peer review may not be possible due to time and resource constraints. For example, Councils may request that a NMFS Science Center provide calculations or analyses used in the development and assessment of fishery management alternatives for area-based or time-based harvest limits. It may be impractical to submit that scientific information to a formal peer review due to time and resource constraints. However, the development of such scientific information should be in accordance with the principles of transparency and openness set forth in this proposed action.

The proposed NS2 guidelines provide guidance that is fundamental for the reliability and integrity of scientific information to be used by NMFS and the Councils to effectively manage and conserve our nation's living marine resources.

Pursuant to its authority under the Information Quality Act (Pub. L. 106-554, Section 515), the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review (70 FR 2664, January 14, 2005) that establishes minimum peer review requirements for “influential scientific information” disseminated by Federal agencies. As described in section II.C, a Council's SSC is responsible for providing ongoing scientific advice to its Council for fishery management decisions. However, section 302(g)(1)(E) of the MSA provides for an optional peer review process: “(T)he Secretary and each Council may establish a peer review process for that Council for scientific information used to advise the Council about the conservation and management of the fishery.” If the Secretary and a Council establish such a process, it will be deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines. This proposed action provides guidance and national quality standards that are widely accepted, which should be followed in order to establish a peer review process per section 302(g)(1)(E). This action provides flexibility to maintain existing peer review processes established by the Secretary and Councils and also clarifies the role of the Councils' SSCs in the scientific review process.

Section 302(g)(1)(E) peer review processes must be carefully designed to maximize the likelihood of an outcome that is objective, provides useful information, and meets the intent or scope of work of the particular process. This proposed action adopts many of the OMB peer review standards, including balance in the peer review process in terms of expertise, knowledge, and bias; lack of conflicts of interest; independence from the work being reviewed; and transparency of the process. A peer review may take many forms, including individual letter or written review or panel reviews. The amount of time and resources spent on any particular review may depend on the novelty and complexity of the scientific information being reviewed. Peer reviewers who are federal employees must comply with all applicable federal ethics requirements (available at: http://www.usoge.gov/federal_employees.aspx). Potential reviewers who are not federal employees must be screened for conflicts of interest in accordance with the procedures set forth in the NOAA Policy on Conflicts of Interest for Peer Review subject to OMB's Peer Review Bulletin (available at: http://www.cio.noaa.gov/Policy_Programs/NOAA_PRB_COI_Policy_110606.html). The nature and scope of each peer review should be developed and defined prior to the selection of reviewers, to ensure reviewers with the appropriate expertise and skills are selected.

Peer review processes established by the Secretary and a Council for that Council should not be duplicative and should focus on providing review for information that has not already undergone rigorous peer review. When the Secretary and a Council develop a peer review process per MSA section 302(g)(1)(E), the proposed NS2 guidelines provide that they must publish a notice and brief description of the process in the Federal Register, make a complete, detailed description of the process publicly available on the Council's Web site, and update it as necessary.

The proposed NS2 guidelines are not intended to replace or result in the duplication of effective peer review processes that have already been established by NMFS and the Councils, such as the Stock Assessment Review Committee (SARC), Southeast Data Assessment Review (SEDAR), Stock Assessment Review (STAR), and Western Pacific Stock Assessment Review (WPSAR). Section 302(g)(1)(E) provides that the peer review process established by the Secretary and a Council may include existing committees or panels. The aforementioned existing peer review processes (SARC, SEDAR, STAR and WPSAR) may qualify as 302(g)(1)(E) review processes, but the Secretary, in conjunction with the relevant Councils, has not yet made that determination. If such a determination is made, the Secretary will announce the decision in the Federal Register.

The impact of the proposed action on current Council peer review practices should be minimal since the proposed peer review standards are consistent with OMB's policy and presently incorporated in the existing peer review processes established by the Secretary and Councils. However, it may be necessary to refine those existing review processes in accordance with these proposed guidelines.

The proposed NS2 guidelines address several roles of the SSC and/or SSC members: the SSC as scientific advisor to its Council; the SSC as a peer review panel; and SSC members' participation on other peer review panels. With regard to the advisory role, the proposed NS2 guidelines provide that the SSCs are the scientific advisory bodies to the Councils.

Section 302(g)(1)(A) of the MSA mandates that “Each Council shall establish, maintain, and appoint the members of a scientific and statistical committee to assist it in the development, collection, evaluation, and peer review of such statistical, biological, economic, social, and other scientific information as is relevant to such Council's development and amendment of any fishery management plan.” As stated in MSA section 302(g)(1)(B), each SSC “shall provide its Council ongoing scientific advice for fishery management decisions, including recommendations for acceptable biological catch, preventing overfishing, maximum sustainable yield, and achieving rebuilding targets, and reports on stock status and health, bycatch, habitat status, social and economic impacts of management measures, and sustainability of fishing practices.”

Questions have arisen with regard to the role of the SSC and peer review process under MSA section 302(h)(6). That section states that “each Council shall * * * develop annual catch limits for each of its managed fisheries that may not exceed the fishing level recommendations of its scientific and statistical committee or the peer review process established under subsection (g).” A possible interpretation of this section is that a Council could not exceed the fishing level recommendation of either the SSC or peer review process; the lower of the two levels would be the limit. However, NMFS believes that section 302(h)(6) should not be interpreted so as to displace the SSC's role in providing advice and recommendations to the Council. While MSA provides for establishment of peer review processes, such processes are optional, and as noted above, MSA section 302(g)(1)(A)-(B) mandates the types of advice the SSC provides for fishery management decisions. Further, as a practical matter, it is not clear how often an SSC or peer review panel would be generating different fishing level recommendations. The purpose of a peer review process is to ensure the quality and credibility of scientific information, rather than providing a specific result, such as a fishing level recommendation.

To address the above issues, as reflected in section (b)(1)(ii) of the proposed NS2 guidelines, a peer review process per section 302(g)(1)(E) should be conducted early in the scientific evaluation process, in order to provide the SSC with a reasonable opportunity to review the peer review report and make recommendations to the Council. The proposed NS2 guidelines also state that the SSC may provide a recommendation to its Council that is inconsistent with the findings of a peer review, in whole or in part, but in such cases, the SSC should prepare a report outlining the areas of disagreement and the rationale and information supporting the SSC's determination. The proposed guidelines also state that the SSC should not repeat the peer review process by conducting a subsequent detailed technical review.

With regard to the SSC conducting a peer review of scientific information, the proposed action provides that the SSC's review should be complementary to, and not duplicative of, existing peer review processes established by the Secretary and each Council. Council and SSC members are encouraged to learn about the details in assessments and peer reviews by attending working group and peer review meetings that occur before any formal SSC evaluations of the scientific information are made.

With regard to SSC members, the proposed NS2 guidelines state that an SSC member may participate in the peer review of scientific information when beneficial due to the expertise and regional knowledge of the SSC member, as long as the SSC member meets the peer review quality standards as described in this proposed action. For an SSC member to participate in a peer review, the proposed action requires screening the SSC member as well as all other potential reviewers for conflicts of interest pursuant to NOAA's Policy on Conflicts of Interest for Peer Reviews Subject to OMB's Peer Review Bulletin. That policy limits review of one's own work. Furthermore, this proposed action provides that the review and evaluation of scientific information by the Councils' SSCs should be transparent, and include the recording of minority viewpoints.

Many ANPR comments focused on the evaluation and recommendations of the SSCs on the scientific information for catch-level specifications and pertinent measures of uncertainty; however, these issues were addressed in the recent revisions to the MSA National Standard 1 (NS1) guidelines (74 FR 3178, January 16, 2009).

The Secretary of Commerce (Secretary) has the responsibility for preparation and review of SAFE reports. The current NS2 guidelines state that the SAFE report is a document or set of documents that provides the Councils with a summary of scientific information, and contain specifications on the contents of SAFE reports. This proposed action would provide further clarification on the purpose and content of the SAFE report. Specifically, it provides guidance on the scientific information that should be included in the SAFE to enable the SSC to fulfill its role in providing its Council with ongoing scientific advice for fishery management decisions.

ANPR comments suggested that a SAFE report should be a single report; however the proposed action maintains the existing NS2 guidelines language that describes the SAFE as a document or set of documents. This is necessary to provide the Secretary flexibility in the preparation of the SAFE report and accommodates differing regional practices with regard to the SAFE report. These proposed guidelines clarify that the SAFE report should include essential fish habitat (EFH) information, in accordance with the EFH provisions contained in § 600.815(a)(10), as a stand-alone chapter or clearly noted section.

The proposed NS2 guideline revisions contain provisions intended to facilitate the use of information in the SAFE reports and its availability to the Councils, NMFS, and public. For example, the proposed NS2 guideline revisions specify, as recommended by ANPR comments, that SAFE reports or similar documents must be made available by the Council or NMFS on a Web site accessible to the public, and that they include a summary of the information they contain and an index or table of contents of each component that comprises the SAFE report.

The proposed action would amend the existing NS2 guidelines by deleting the recommendation that the SAFE report contain information on safety for the fishery at issue. Safety of life at sea is now addressed in the National Standard 10 guidelines at § 600.355.

This proposed action maintains the current NS2 guidelines language on FMP development, with only minor changes to the organization of the text.

National Research Council of the National Academies (NRC). 2004. Improving the use of the “best scientific information available” standard in fisheries management. The National Academies Press, Washington, DC 105 pp.; http://www.nap.edu/openbook.php.

NOAA Office of the Chief Information Officer & High Performance Computing and Communications. 2006. National Oceanic and Atmospheric Administration Policy on Conflicts of Interest for Peer Review Subject to OMB Peer Review Bulletin. NOAA Memorandum, November 6, 2006; http://www.cio.noaa.gov/Policy_Programs/NOAA_PRB_COI_Policy_110606.html.

Office of Management and Budget (OMB). 2004. Final Information Quality Bulletin for Peer Review. Executive Office of the President, Office of Management and Budget, memorandum M-05-03; December 16, 2004.

The NMFS Assistant Administrator has determined that this proposed action is consistent with the provisions of the MSA and other applicable law, subject to further consideration after public comment.

This proposed action has been determined to be not significant for purposes of Executive Order 12866.

NMFS has prepared a regulatory impact review of this action, which is available at: http://www.nmfs.noaa.gov/msa2007/otherprovisions.html. This analysis describes the economic impact this proposed action, if adopted, would have on small entities of the United States. NMFS invites the public to comment on this proposal and the supporting analysis.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that these proposed revisions to the NS2 guidelines, if adopted, would not have any significant economic impact on a substantial number of small entities, as follows:

For the reasons stated in the preamble, 50 CFR part 600 is proposed to be amended as follows: