Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Implementation of Nondiscretionary, Non-Electronic Benefits Transfer-Related Provisions, 59885-59890 [2011-24722]

Download as PDF 59885 Rules and Regulations Federal Register Vol. 76, No. 188 Wednesday, September 28, 2011 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 246 RIN 0584–AE13 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Implementation of Nondiscretionary, Non-Electronic Benefits Transfer-Related Provisions Food and Nutrition Service (FNS), USDA. ACTION: Final rule. AGENCY: This final rule incorporates into the regulations governing the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) several changes set forth in the Healthy, Hunger-Free Kids Act of 2010 (HHFK Act). These provisions address: certification periods for children participating in the WIC Program; increased emphasis on breastfeeding promotion and support; compiling and publishing data for partially and fully breastfed infants; sharing nutrition education materials with institutions participating in the Child and Adult Care Food Program (CACFP); and infant formula (and other foods) rebate management. DATES: Effective Date: This rule is effective on October 28, 2011. Implementation Date: The provisions in this rule must be implemented no later than October 1, 2011. FOR FURTHER INFORMATION CONTACT: Debra R. Whitford, Director, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 520, Alexandria, Virginia 22302; (703) 305– 2746; e-mail: Debbie.Whitford@fns.usda.gov. SUPPLEMENTARY INFORMATION: emcdonald on DSK5VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 Background This final rule amends the WIC regulations to implement five nondiscretionary provisions from Public Law 111–296, the Healthy, Hunger-Free Kids Act of 2010 (HHFK Act), signed into law on December 13, 2010. FNS previously issued policy and guidance to State agencies on implementation of the legislative requirements addressed in this rulemaking because four of the five nondiscretionary provisions of the HHFK Act were effective on October 1, 2010. The fifth provision, the recording of rebate payments, becomes effective on October 1, 2011. FNS anticipates that the current rule will accomplish the goals of the HHFK Act concerning participant certification, breastfeeding support and general program administration. Specifically, the WIC provisions are as follows: 1. Extended Certification Period for Children Section 131 of the HHFK Act amends section 17(d)(3) of the Child Nutrition Act (CNA) (42 U.S.C. 1786(d)(3)) to allow State agencies the option to certify participant children for a period of up to one year if the State agency electing this option ensures that participant children receive required health and nutrition assessments. Section 246.7(g)(1)(v) of the WIC regulations (7 CFR 246.7(g)(1)(v))currently provides that children participating in the WIC Program shall be certified at intervals of approximately six months, ending with the last day of the month in which a child reaches his/her fifth birthday. The new legislative provision now allows a participant child, at the State agency’s option, to be certified for a period of up to one year. This increased flexibility will provide administrative relief for participant children’s parents, as well as for State and local agencies. In some cases, it will also allow a local WIC agency to certify a toddler, a breastfeeding mother, and an infant in the same household for the same relative period of time, as all three categories of participants may now be certified for up to one year if the State agency ensures that health care and nutrition services are not diminished. To comply with the legislative intent of the extended certification periods, i.e., that participant children receive required health and nutrition assessments, WIC State agencies PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 electing the one-year option must continue to provide the nutrition services a participant would otherwise receive during a shorter certification period. Delivering quality nutrition services to WIC participants and to their parents/caregivers distinguishes WIC as an exemplary nutrition assistance program. This provision became effective on October 1, 2010, as stipulated in the HHFK Act and was implemented via a March 11, 2011 memorandum #2011–2, ‘‘Implementation of the Nondiscretionary, Non-Electronic Benefits Transfer-Related Provisions of Public Law 111–296.’’ This final rule amends § 246.7(g) to add the State agency option to allow certification of children for a period of up to one year, provided the local agency ensures that the participant child receives the required nutrition services. Section 246.4(a) is amended to require State agencies electing to implement this option to address in the State Plan of Operations how participants will receive required health and nutrition assessments when certified for a period of greater than six months. A corresponding amendment is made to § 246.11(e)(3) to add that nutrition education contacts must be made available quarterly for participants certified for a period of time in excess of six months to ensure that health care and nutrition services are not diminished. 2. Increased Support for Breastfeeding in the WIC Program The Department has long been strongly committed to the support and promotion of breastfeeding. WIC has historically promoted breastfeeding to all pregnant women as the optimal infant feeding choice, unless medically contraindicated. Current WIC regulations (§§ 246.7(e)(1)(iii), 246.7(g)(1)(iii), 246.10(e)(7), and 246.11(c)) contain provisions to encourage women to breastfeed and to provide appropriate nutritional support for breastfeeding participants, including: • Information provided to WIC mothers choosing to breastfeed through counseling and breastfeeding educational materials; • Follow-up support through peer counselors; • Eligibility to participate in WIC longer than non-breastfeeding mothers; E:\FR\FM\28SER1.SGM 28SER1 emcdonald on DSK5VPTVN1PROD with RULES 59886 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations • Enhanced food package for mothers who exclusively breastfeed their infants; and • Provision of breast pumps, breast shells or supplemental nursing systems to help support the initiation and continuation of breastfeeding as allowable WIC costs. Section 231 of the HHFK Act amends several paragraphs in section 17 of the CNA to reinforce the importance of the promotion and support of breastfeeding as an integral element of WIC services and benefits. The specific changes are: 1. Section 17(a) of the CNA is amended to add references to breastfeeding promotion and support to the WIC Program’s general purpose and to the benefits provided. This addition is incorporated by this rulemaking into § 246.1 and § 246.11(b) of the WIC regulations, but does not require any specific action on the part of WIC State agencies. 2. The definition of ‘‘Costs of nutrition services and administration’’ in Section 17(b)(4) of the CNA is amended to include ‘‘breastfeeding support and promotion.’’ Breastfeeding support and promotion has always been an allowable cost under nutrition services and administration (NSA) funds as defined in § 246.2; this provision now makes the definitions in the CNA and the regulations consistent, and as with the amendment to the statement of purpose for the WIC Program cited above, does not require any specific action by WIC State agencies. 3. Section 17(c)(1) of the CNA is amended to include ‘‘breastfeeding support and promotion’’ as one of the specific services to be provided under the WIC Program. This phrase, and close variations of it, are added throughout the WIC regulations wherever references to WIC nutrition education services are found. While breastfeeding support and promotion have always been considered to be part of the nutrition services provided through the WIC Program, the HHFK Act now ensures that such functions are specifically named. This final rule amends § 246.11(a)(1) to include breastfeeding support and promotion as a benefit of the Program, and to clarify that breastfeeding support and promotion shall be made available at no cost to participants. 4. Section 17(e)(2) of the CNA is amended to expand WIC State and local agency staff training requirements to include breastfeeding support and education. Therefore, § 246.11(c) is amended to require State agencies to include breastfeeding promotion and support as part of their responsibilities. All WIC State agencies are now VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 expected to provide an assurance via the State Plan of Operations to the effect that any training related to nutrition education and counseling provided to State and local staff will include breastfeeding promotion and support as part of such training. 5. Section 17(f)(6)(B) of the CNA is amended to expand the limitations on State agencies’ authority to provide WIC food instruments by a method other than direct pick-up at the local agency, specifically to include participants scheduled for breastfeeding counseling. Section 246.12(r)(4) is amended accordingly to require participants, parents and caretakers of infant and child participants, and proxies to pick up food instruments and cash value vouchers in person when scheduled for breastfeeding counseling. State agencies must also ensure that WIC EBT benefits will not be not loaded, nor will paper food instruments be mailed or otherwise issued to participants in some method besides face-to-face distribution at the local agency, if the participant is scheduled for nutrition education, breastfeeding counseling, or recertification. All of these provisions became effective on October 1, 2010, as stipulated in the HHFK Act and were implemented via the March 11, 2011 memorandum, ‘‘Implementation of the Nondiscretionary, Non-Electronic Benefits Transfer-Related Provisions of Public Law 111–296.’’ 3. Data Collection for Breastfed Infants Section 231 of the HHFK Act also amends section 17(h)(4)(A) of the CNA (42 U.S.C. 1786(h)(4)(A)) to require USDA to compile, and to publish annually, breastfeeding performance measurements based on program participant data on the number of partially and fully breastfed infants for each WIC State agency and each local WIC agency. This requirement became effective on October 1, 2010. WIC State agencies currently report cumulative data on the number of partially and fully breastfed infants as part of their monthly participation report. WIC local agencies provide their data on partially and fully breastfed infants to the State agency for the cumulative monthly participation report; however, the individual locallevel data are currently not reported by State agencies to FNS. The local agency data on fully and partially breastfed infants reported monthly to the State will now be compiled by the State agency, using a format provided by FNS for the annual local level data reporting. This information will then be reported to PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 FNS and published annually by USDA. Section 246.25(a) is revised to reflect the reporting of this local level data to FNS by the State agency. No new burden is incurred since this information is currently collected by the local agency and submitted on a monthly basis to the State agency for its monthly participation report. 4. Sharing Materials With CACFP Nutrition education is an important component of WIC nutrition services. It is provided to all pregnant, breastfeeding and postpartum participants as well as to the parents or caregivers of infant and child participants, and when appropriate, to child participants directly. As such, the WIC Program develops a variety of nutrition education materials for use by State and local cooperators. Section 351 of the HHFK Act amends section 17(e)(3)(B) of the CNA (42 U.S.C. 1786(e)(3)(B)) to allow local WIC agencies, at the State agency’s option, to share nutrition education materials with institutions participating in the CACFP at no cost, if a written materials sharing agreement exists between WIC State or local agencies and CACFP institutions. WIC State agencies may initiate a sharing agreement with their State-level CACFP counterparts that would apply Statewide, or may authorize their local agencies or clinics to initiate a sharing agreement at the local level with their local level CACFP counterparts. This requirement became effective on October 1, 2010, as stipulated in the HHFK Act, and was implemented via the March 11, 2011 memorandum, ‘‘Implementation of the Nondiscretionary, Non-Electronic Benefits Transfer-Related Provisions of Public Law 111–296.’’ This final rule amends § 246.11(c)(3) to allow State agencies the option to allow their local agencies or clinics to share nutrition education materials with CACFP entities. 5. Recording WIC Rebate Payments Section 352(b) of the HHFK Act amends section 17(h)(8) of the CNA (42 U.S.C. 1786(h)(8)) to add a new paragraph (K) requiring WIC State agencies to report rebate payments received from manufacturers in the month in which the payments are received, rather than in the month in which the payments are earned. To assist State agencies in making the transition to this change in reporting, Section 352(f) of the HHFK Act amends section 17(i) of the CNA (42 U.S.C. 1786(i)) to add a new paragraph (8) providing for temporary adjustments in spending authority. E:\FR\FM\28SER1.SGM 28SER1 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations emcdonald on DSK5VPTVN1PROD with RULES This provision requires State agencies to report rebate payments from manufacturers on the FNS–798 (Financial Management and Participation Report) in the month in which the payments are received, rather than in the month that rebates are earned. This change does not affect how rebates are earned and billed on rebate invoices to manufacturers, which will continue in accordance with current and future rebate contracts. Rather, this change in reporting will assist the State agency in more accurately estimating its annual amount of rebates, which is a key component in determining its need for food funds during the course of the fiscal year. This requirement becomes effective on October 1, 2011, as stipulated in the HHFK Act. Section 246.14 is modified to incorporate the reporting change. 6. New Rebate Bid Solicitation Requirements Section 352(c) of the HHFK Act amends section 17(h)(9) of the CNA (42 U.S.C. 1786(h)(9)) to add several new requirements for the solicitation and billing of all rebates on authorized foods, including infant formula, specifically: A. The bid solicitation must: Æ Identify the composition of State alliances for the purposes of a cost containment measure, and Æ Verify that no additional States shall be added to the State alliance between the date of the bid solicitation and the end of the contract. B. The State agency must have a system to ensure that rebate invoices under competitive bidding provide a reasonable estimate or an actual count of the number of units sold to WIC participants. C. The State agency must publicly open and read all bids aloud on the day the bids are due. D. The State agency must provide a minimum of 30 days between the publication of the solicitation and the date on which the bids are due, unless exempted by the Secretary. E. The State agency must extend current provisions and requirements regarding State alliances for infant formula rebates to all other authorized foods for which rebates are sought. Rebates are offsets to food costs and allow the Program to serve a greater number of participants without increasing the annual appropriation of WIC funds by Congress. Infant formula rebates have been a very successful cost containment initiative in the WIC Program since the mid-1980’s. Over the years, State agencies have also implemented rebate contracts for other VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 foods, such as infant cereal and juice; and more recently, infant foods such as fruit, vegetables and meat. A key to the success of rebate contracts is ensuring fair and open competition for the contracts. The rebate bid solicitation requirements became effective on October 1, 2010, as stipulated by the HHFK Act. Section 246.16a is modified to incorporate these new requirements. Notice and Comment In accordance with the Secretary’s Statement of Policy (36 FR 13804), it is found and determined with good cause that it is unnecessary to engage in the Notice and Comment provisions of 5 U.S.C. 553 normally required before the adoption of final regulations in an FNSsponsored program. The provisions set forth in this rulemaking are nondiscretionary, i.e., the Department has not exercised any authority to interpret the statutory provisions beyond the language that is specifically provided in the legislation. The nondiscretionary nature of the provisions contained in Public Law 111–296 means that notice and comment would serve no useful purpose in the promulgation of this rulemaking. Executive Orders 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated not significant under section 3(f) of Executive Order 12866. Regulatory Impact Analysis This rule has been designated as not significant by the Office of Management and Budget; therefore, a Regulatory Impact Analysis is not necessary. Regulatory Flexibility Act This final rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act of 1980 (5 U.S.C. 601–612). Pursuant to that review, it has been certified that this rule will not have a significant economic impact on a substantial number of small entities. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 59887 This rule incorporates into the regulations governing the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) several changes set forth in the Healthy, Hunger-Free Kids Act of 2010 (HHFK Act). The provisions of this rulemaking are applicable to all State and local agencies that administer the WIC Program. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104–4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under Section 202 of the UMRA, FNS generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with ‘‘Federal mandates’’ that may result in expenditures by State, local, or tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, Section 205 of the UMRA generally requires FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This final rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local or tribal governments or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of Sections 202 and 205 of the UMRA. Executive Order 12372 WIC is listed in the Catalog of Federal Domestic Assistance under No. 10.557. For the reasons set forth in the final rule at 7 CFR part 3015, Subpart V and related Notice (48 FR 29115, June 24, 1983), this program is included in the scope of Executive Order 12372 that requires intergovernmental consultation with State and local officials. Federalism Summary Impact Statement Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency’s considerations in terms of the three categories called for under Section 6(b)(2)(B) of Executive Order 13132. FNS has considered the impact of this rule on State and local governments and E:\FR\FM\28SER1.SGM 28SER1 59888 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations has determined that this rule does not have federalism implications. Therefore, under Section 6(b) of the Executive Order, a federalism summary impact statement is not required. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations, or policies that conflict with its provisions or that would otherwise impede its full implementation. This rule is not intended to have retroactive effect unless so specified in the Dates paragraph of the preamble to the final rule. Prior to any judicial challenge to the application of the provisions of this rule, all applicable administrative procedures must be exhausted. In WIC, the administrative procedures are as follows: State and local agencies, farmers, farmers’ markets, and roadside stands—State agency hearing procedures issued pursuant to 7 CFR 246.18; applicants and participants— State agency hearing procedures pursuant to 7 CFR 246.18; sanctions against State agencies (but not claims for repayment assessed against a State agency) pursuant to 7 CFR 246.19— administrative appeal in accordance with 7 CFR 246.16, and procurement by State or local agencies—administrative appeal to the extent required by 7 CFR 3016.36. emcdonald on DSK5VPTVN1PROD with RULES Civil Rights Impact Analysis FNS has reviewed this rule in accordance with Departmental Regulations 4300–4, ‘‘Civil Rights Impact Analysis,’’ and 1512–1, ‘‘Regulatory Decision Making Requirements.’’ After a careful review of the rule’s intent and provisions, FNS has determined that this rule is not intended to limit or reduce in any way the ability of protected classes of individuals to receive benefits in the WIC Program. Federal WIC regulations specifically prohibit State agencies that administer the WIC Program, and their cooperators, from engaging in actions that discriminate against any individual in any of the protected classes (see 7 CFR 246.8 for the nondiscrimination policy in the WIC Program). Where State agencies have options, and they choose to implement a certain provision, they must implement it in such a way that it complies with the WIC Program regulations set forth at § 246.8. VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 Executive Order 13175—Consultation and Coordination With Indian Tribal Governments Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. USDA will respond in a timely and meaningful manner to all Tribal government requests for consultation concerning this rule and will provide additional venues, such as webinars and teleconferences, to host periodic collaborative conversations with Tribal officials or their designees concerning ways to improve this rule in Indian country. We are not aware of any current Tribal laws that could be in conflict with this final rule. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR part 1320) requires that the Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current, valid OMB control number. While some of the provisions of this rule are related to the current collection of information for the WIC Program, this final rule has no new information collection requirements. The information collection burdens associated with collecting local agency breastfeeding data and the recording of rebates in this final rule have been previously approved under OMB No. 0584–0045, WIC Financial Management and Participation Report with Addendum. E-Government Act Compliance FNS is committed to complying with the E-Government Act of 2002 to promote the use of the internet and other information technologies to provide increased opportunities to provide for citizen access to government information and services, and for other purposes. State Plan amendments regarding the implementation of the provisions contained in this rule, as is the case with the entire State Plan, may be transmitted electronically by the PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 State agency to FNS. Also, State agencies may provide WIC Program information, as well as their financial reports, to FNS electronically. List of Subjects in 7 CFR Part 246 Food assistance programs, Food donations, Grant programs—Social programs, Indians, Nutrition education, Public assistance programs, WIC. For reasons discussed above, 7 CFR part 246 is amended as follows: PART 246—SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN 1. The authority citation for part 246 continues to read as follows: ■ Authority: 7 U.S.C. 1786. § 246.1 [Amended] 2. Section 246.1 is amended by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘education’’ in the third sentence. ■ § 246.3 [Amended] 3. Section 246.3 is amended in paragraph (e) by adding the phrase ‘‘breastfeeding promotion and support,’’ after the word ‘‘education,’’ in the first sentence. ■ 4. In § 246.4: ■ a. Revise paragraph (a)(9); ■ b. Amend paragraph (a)(11)(ii) by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘education’’ in the first sentence; and ■ c. Redesignate paragraphs (a)(19) through (a)(26) as paragraphs (a)(20) through (a)(27), and add a new paragraph (a)(19). The revisions and additions read as follows: ■ § 246.4 State plan. (a) * * * (9) The State agency’s nutrition education goals and action plans to include: (i) A description of the methods that will be used to provide drug and other harmful substance abuse information, to promote and support breastfeeding, and to meet the special nutrition education needs of migrant farmworkers and their families, Indians, and homeless persons. (ii) State agencies have the option to provide nutrition education materials to institutions participating in the CACFP at no cost, as long as a written agreement for sharing such materials is in place between the relevant WIC and CACFP entities. State agencies may initiate a sharing agreement with their State-level CACFP counterparts that would apply statewide, or may E:\FR\FM\28SER1.SGM 28SER1 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations authorize their local agencies or clinics to initiate a sharing agreement at the local level with their local level CACFP counterparts. * * * * * (19) The State agency’s plan to ensure that participants receive required health and nutrition assessments when certified for a period of greater than six months. * * * * * § 246.6 [Amended] 5. In § 246.6 paragraph (b)(6) is amended by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘services’’. ■ 6. In § 246.7: ■ a. Revise the fourth sentence in paragraph (e); ■ b. Revise paragraph (g)(1)(v) to read as set forth below; ■ c. Amend paragraph (j)(2)(iii) by removing the phrase ‘‘and nutrition education’’ and adding in its place the phrase ‘‘, nutrition education and breastfeeding support’’; and ■ d. Amend paragraph (m)(1)(i)(C) by removing the phrase ‘‘and nutrition education’’ and adding in its place the phrase ‘‘, nutrition education and breastfeeding support’’; ■ e. Amend paragraph (m)(4) by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘education’’. 59889 The revisions read as follows: ■ § 246.7 Certification of participants. * * * * * (e) * * * Nutritional risk data shall be documented in the participant’s file and shall be used to assess an applicant’s nutritional status and risk; tailor the food package to address nutritional needs; design appropriate nutrition education, including breastfeeding promotion and support; and make referrals to health and social services for follow-up, as necessary and appropriate. * * * * * (g) * * * (1) * * * A/an: Will be certified: * (v) Child ............ * * * * * * Approximately every six months ending with the last day of the month in which a child reaches his/her fifth birthday. The State agency may permit its local agencies to certify a child for a period of up to one year, provided the local agency ensures that the child receives the required health and nutrition assessments, as set forth in § 246.11(e)(3). * * * * * 7. In § 246.11: a. Amend paragraphs (a)(1), and (b) introductory text, by adding the phrase ‘‘including breastfeeding promotion and support,’’ after the phrase ‘‘Nutrition education’’ wherever it appears; ■ b. Amend paragraph (a)(2) by adding the phrase ‘‘, including breastfeeding promotion and support, as appropriate,’’ after the word ‘‘education’’ in the first sentence; ■ c. Amend paragraph (c) introductory text by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘responsibilities’’; ■ d. Add new paragraph (c)(8); ■ e. Amend paragraph (d) introductory text by adding the phrase ‘‘, including breastfeeding promotion and support,’’ after the word ‘‘responsibilities’’; ■ f. Revise the first sentence in paragraph (d)(1); ■ g. Revise the first sentence in paragraph (d)(2); ■ h. Amend paragraph (e)(1) by adding the phrase ‘‘including breastfeeding promotion and support,’’ after the phrase ‘‘nutrition education’’ ; and ■ i. Revise paragraph (e)(3). The revisions and additions read as follows: emcdonald on DSK5VPTVN1PROD with RULES ■ ■ § 246.11 Nutrition education. * * * * * (c) * * * (8) Determine if local agencies or clinics can share nutrition educational materials with institutions participating in the Child and Adult Care Food Program established under section 17 of VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 the Richard B. Russell National School Lunch Act (42 U.S.C. 1766) at no cost to that program, if a written materials sharing agreement exists between the relevant agencies. (d) * * * (1) Make nutrition education, including breastfeeding promotion and support, available or enter into an agreement with another agency to make nutrition education available to all adult participants, and to parents or caretakers of infant and child participants, and whenever possible and appropriate, to child participants.* * * (2) Develop an annual local agency nutrition education plan, including breastfeeding promotion and support, consistent with the State agency’s nutrition education component of Program operations and in accordance with this part and FNS guidelines. * * * (e) * * * (3) Nutrition education contacts shall be made available at a quarterly rate to parents or caretakers of infant and child participants certified for a period in excess of six months. Nutrition education contacts shall be scheduled on a periodic basis by the local agency, but such contacts do not necessarily need to take place in each quarter of the certification period. * * * * * § 246.12 [Amended] 8. Section 246.12(d) is amended by adding the phrase ‘‘, and breastfeeding counseling ‘‘after the word ‘‘education’’. ■ PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 9. In § 246.14: a. Amend paragraph (c)(1) by adding the phrase ‘‘, including breastfeeding promotion and support, ’’ after the word ‘‘education’’ in the eleventh sentence; ■ b. Add a new paragraph (f). The addition reads as follows: ■ ■ § 246.14 Program costs. * * * * * (f) Use of funds received as rebates from manufacturers. The State agency must credit and report rebate payments received from manufacturers in the month in which the payments are received. ■ 10. In § 246.16a: ■ a. Revise the section heading; ■ b. Redesignate paragraphs (c)(1) through (c)(8) as paragraphs (c)(2) through (c)(9); ■ c. Remove introductory text of paragraph (c) and add a new paragraph (c)(1); ■ d. Amend newly designated paragraph (c)(3) by adding a third sentence; and ■ e. Revise paragraphs (g) and (k). The additions and revisions read as follows: § 246.16a Infant formula and authorized foods cost containment. * * * * * (c) What is the single-supplier competitive system?—(1) Under the single-supplier competitive system, a State agency solicits sealed bids from infant formula manufacturers to supply and provide a rebate for infant formulas. The State agency must conduct the E:\FR\FM\28SER1.SGM 28SER1 59890 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations procurement in a manner that maximizes full and open competition consistent with the requirements of this section. A State agency must: (i) Provide a minimum of 30 days between the publication of the solicitation and the date on which the bids are due, unless exempted by the Secretary; and (ii) Publicly open and read all bids aloud on the day the bids are due. * * * * * (c) * * * (3) * * * The bid solicitation must identify the composition of the State alliances for the purpose of a cost containment measure, and verify that no additional State shall be added to the State alliance between the date of the bid solicitation and the end of the contract. * * * * * * * * (g) May a State agency implement cost containment systems for other supplemental foods? Yes, when a State agency finds that it is practicable and feasible to implement a cost containment system for any WIC food other than infant formula. The State agency must: (1) Provide notification to FNS by means of the State agency’s State Plan. (2) Comply with paragraphs (c)(2) and (k) of this section. (3) Provide a minimum of 30 days between the publication of the solicitation and the date on which the bids are due, unless exempted by the Secretary. The State must publicly open and read all bids aloud on the day the bids are due. (4) Issue separate solicitations for authorized foods if any alliance served a monthly average of more than 100,000 infants during the preceding 12-month period. * * * * * (k) What are the requirements for infant formula and authorized food rebate invoices? A State agency must have a system in place that ensures infant formula and authorized food rebate invoices, under competitive bidding, provide a reasonable estimate or an actual count of the number of units purchased by participants in the program. * * * * * emcdonald on DSK5VPTVN1PROD with RULES § 246.19 [Amended] 11. Section 246.19(b)(2) is amended by adding the phrase ‘‘breastfeeding promotion and support,’’ after the word ‘‘education,’’ in the first sentence. ■ 12. In § 246.25: ■ a. Amend paragraph (a)(1) by adding the phrase ‘‘including breastfeeding ■ VerDate Mar<15>2010 16:23 Sep 27, 2011 Jkt 223001 promotion and support,’’ after the word ‘‘education,’’; ■ b. Redesignate paragraphs (b)(1)(i)(C) and (D) as paragraphs (b)(1)(i)(D) and (E), and add a new paragraph (b)(1)(i)(C); and ■ c. Add new paragraph (b)(2)(iii). The additions read as follows: § 246.25 Records and reports. (b) * * * (1) * * * (i) * * * (C) Actual and projected rebate payments received from manufacturers. * * * * * (2) * * * (iii) The State agency must submit local agency breastfeeding participation data on an annual basis to FNS. * * * * * Dated: September 20, 2011. Audrey Rowe, Administrator, Food and Nutrition Service. [FR Doc. 2011–24722 Filed 9–27–11; 8:45 am] BILLING CODE 3410–30–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 95 [Docket No. 30805; Amdt. No. 496] IFR Altitudes; Miscellaneous Amendments Federal Aviation Administration (FAA), DOT. ACTION: Final rule. AGENCY: This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas. DATES: Effective Date: 0901 UTC, October 20, 2011. FOR FURTHER INFORMATION CONTACT: Rick Dunham, Flight Procedure Standards Branch (AMCAFS–420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK 73169 (Mail Address: P.O. Box SUMMARY: PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 25082 Oklahoma City, OK 73125) telephone: (405) 954–4164. SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95. The Rule The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the nticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 95 Airspace, Navigation (air). E:\FR\FM\28SER1.SGM 28SER1

Agencies

[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59885-59890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24722]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / 
Rules and Regulations

[[Page 59885]]



DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Part 246

RIN 0584-AE13


Special Supplemental Nutrition Program for Women, Infants and 
Children (WIC): Implementation of Nondiscretionary, Non-Electronic 
Benefits Transfer-Related Provisions

AGENCY: Food and Nutrition Service (FNS), USDA.

ACTION: Final rule.

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

SUMMARY: This final rule incorporates into the regulations governing 
the Special Supplemental Nutrition Program for Women, Infants and 
Children (WIC) several changes set forth in the Healthy, Hunger-Free 
Kids Act of 2010 (HHFK Act). These provisions address: certification 
periods for children participating in the WIC Program; increased 
emphasis on breastfeeding promotion and support; compiling and 
publishing data for partially and fully breastfed infants; sharing 
nutrition education materials with institutions participating in the 
Child and Adult Care Food Program (CACFP); and infant formula (and 
other foods) rebate management.

DATES: Effective Date: This rule is effective on October 28, 2011.
    Implementation Date: The provisions in this rule must be 
implemented no later than October 1, 2011.

FOR FURTHER INFORMATION CONTACT: Debra R. Whitford, Director, 
Supplemental Food Programs Division, Food and Nutrition Service, USDA, 
3101 Park Center Drive, Room 520, Alexandria, Virginia 22302; (703) 
305-2746; e-mail: Debbie.Whitford@fns.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    This final rule amends the WIC regulations to implement five 
nondiscretionary provisions from Public Law 111-296, the Healthy, 
Hunger-Free Kids Act of 2010 (HHFK Act), signed into law on December 
13, 2010. FNS previously issued policy and guidance to State agencies 
on implementation of the legislative requirements addressed in this 
rulemaking because four of the five nondiscretionary provisions of the 
HHFK Act were effective on October 1, 2010. The fifth provision, the 
recording of rebate payments, becomes effective on October 1, 2011. FNS 
anticipates that the current rule will accomplish the goals of the HHFK 
Act concerning participant certification, breastfeeding support and 
general program administration. Specifically, the WIC provisions are as 
follows:

1. Extended Certification Period for Children

    Section 131 of the HHFK Act amends section 17(d)(3) of the Child 
Nutrition Act (CNA) (42 U.S.C. 1786(d)(3)) to allow State agencies the 
option to certify participant children for a period of up to one year 
if the State agency electing this option ensures that participant 
children receive required health and nutrition assessments. Section 
246.7(g)(1)(v) of the WIC regulations (7 CFR 246.7(g)(1)(v))currently 
provides that children participating in the WIC Program shall be 
certified at intervals of approximately six months, ending with the 
last day of the month in which a child reaches his/her fifth birthday. 
The new legislative provision now allows a participant child, at the 
State agency's option, to be certified for a period of up to one year. 
This increased flexibility will provide administrative relief for 
participant children's parents, as well as for State and local 
agencies. In some cases, it will also allow a local WIC agency to 
certify a toddler, a breastfeeding mother, and an infant in the same 
household for the same relative period of time, as all three categories 
of participants may now be certified for up to one year if the State 
agency ensures that health care and nutrition services are not 
diminished. To comply with the legislative intent of the extended 
certification periods, i.e., that participant children receive required 
health and nutrition assessments, WIC State agencies electing the one-
year option must continue to provide the nutrition services a 
participant would otherwise receive during a shorter certification 
period. Delivering quality nutrition services to WIC participants and 
to their parents/caregivers distinguishes WIC as an exemplary nutrition 
assistance program.
    This provision became effective on October 1, 2010, as stipulated 
in the HHFK Act and was implemented via a March 11, 2011 memorandum 
2011-2, ``Implementation of the Nondiscretionary, Non-
Electronic Benefits Transfer-Related Provisions of Public Law 111-
296.'' This final rule amends Sec.  246.7(g) to add the State agency 
option to allow certification of children for a period of up to one 
year, provided the local agency ensures that the participant child 
receives the required nutrition services. Section 246.4(a) is amended 
to require State agencies electing to implement this option to address 
in the State Plan of Operations how participants will receive required 
health and nutrition assessments when certified for a period of greater 
than six months.
    A corresponding amendment is made to Sec.  246.11(e)(3) to add that 
nutrition education contacts must be made available quarterly for 
participants certified for a period of time in excess of six months to 
ensure that health care and nutrition services are not diminished.

2. Increased Support for Breastfeeding in the WIC Program

    The Department has long been strongly committed to the support and 
promotion of breastfeeding. WIC has historically promoted breastfeeding 
to all pregnant women as the optimal infant feeding choice, unless 
medically contraindicated. Current WIC regulations (Sec. Sec.  
246.7(e)(1)(iii), 246.7(g)(1)(iii), 246.10(e)(7), and 246.11(c)) 
contain provisions to encourage women to breastfeed and to provide 
appropriate nutritional support for breastfeeding participants, 
including:
     Information provided to WIC mothers choosing to breastfeed 
through counseling and breastfeeding educational materials;
     Follow-up support through peer counselors;
     Eligibility to participate in WIC longer than non-
breastfeeding mothers;

[[Page 59886]]

     Enhanced food package for mothers who exclusively 
breastfeed their infants; and
     Provision of breast pumps, breast shells or supplemental 
nursing systems to help support the initiation and continuation of 
breastfeeding as allowable WIC costs.
    Section 231 of the HHFK Act amends several paragraphs in section 17 
of the CNA to reinforce the importance of the promotion and support of 
breastfeeding as an integral element of WIC services and benefits. The 
specific changes are:
    1. Section 17(a) of the CNA is amended to add references to 
breastfeeding promotion and support to the WIC Program's general 
purpose and to the benefits provided. This addition is incorporated by 
this rulemaking into Sec.  246.1 and Sec.  246.11(b) of the WIC 
regulations, but does not require any specific action on the part of 
WIC State agencies.
    2. The definition of ``Costs of nutrition services and 
administration'' in Section 17(b)(4) of the CNA is amended to include 
``breastfeeding support and promotion.'' Breastfeeding support and 
promotion has always been an allowable cost under nutrition services 
and administration (NSA) funds as defined in Sec.  246.2; this 
provision now makes the definitions in the CNA and the regulations 
consistent, and as with the amendment to the statement of purpose for 
the WIC Program cited above, does not require any specific action by 
WIC State agencies.
    3. Section 17(c)(1) of the CNA is amended to include 
``breastfeeding support and promotion'' as one of the specific services 
to be provided under the WIC Program. This phrase, and close variations 
of it, are added throughout the WIC regulations wherever references to 
WIC nutrition education services are found. While breastfeeding support 
and promotion have always been considered to be part of the nutrition 
services provided through the WIC Program, the HHFK Act now ensures 
that such functions are specifically named. This final rule amends 
Sec.  246.11(a)(1) to include breastfeeding support and promotion as a 
benefit of the Program, and to clarify that breastfeeding support and 
promotion shall be made available at no cost to participants.
    4. Section 17(e)(2) of the CNA is amended to expand WIC State and 
local agency staff training requirements to include breastfeeding 
support and education. Therefore, Sec.  246.11(c) is amended to require 
State agencies to include breastfeeding promotion and support as part 
of their responsibilities. All WIC State agencies are now expected to 
provide an assurance via the State Plan of Operations to the effect 
that any training related to nutrition education and counseling 
provided to State and local staff will include breastfeeding promotion 
and support as part of such training.
    5. Section 17(f)(6)(B) of the CNA is amended to expand the 
limitations on State agencies' authority to provide WIC food 
instruments by a method other than direct pick-up at the local agency, 
specifically to include participants scheduled for breastfeeding 
counseling. Section 246.12(r)(4) is amended accordingly to require 
participants, parents and caretakers of infant and child participants, 
and proxies to pick up food instruments and cash value vouchers in 
person when scheduled for breastfeeding counseling. State agencies must 
also ensure that WIC EBT benefits will not be not loaded, nor will 
paper food instruments be mailed or otherwise issued to participants in 
some method besides face-to-face distribution at the local agency, if 
the participant is scheduled for nutrition education, breastfeeding 
counseling, or recertification.
    All of these provisions became effective on October 1, 2010, as 
stipulated in the HHFK Act and were implemented via the March 11, 2011 
memorandum, ``Implementation of the Nondiscretionary, Non-Electronic 
Benefits Transfer-Related Provisions of Public Law 111-296.''

3. Data Collection for Breastfed Infants

    Section 231 of the HHFK Act also amends section 17(h)(4)(A) of the 
CNA (42 U.S.C. 1786(h)(4)(A)) to require USDA to compile, and to 
publish annually, breastfeeding performance measurements based on 
program participant data on the number of partially and fully breastfed 
infants for each WIC State agency and each local WIC agency.
    This requirement became effective on October 1, 2010. WIC State 
agencies currently report cumulative data on the number of partially 
and fully breastfed infants as part of their monthly participation 
report. WIC local agencies provide their data on partially and fully 
breastfed infants to the State agency for the cumulative monthly 
participation report; however, the individual local-level data are 
currently not reported by State agencies to FNS.
    The local agency data on fully and partially breastfed infants 
reported monthly to the State will now be compiled by the State agency, 
using a format provided by FNS for the annual local level data 
reporting. This information will then be reported to FNS and published 
annually by USDA. Section 246.25(a) is revised to reflect the reporting 
of this local level data to FNS by the State agency. No new burden is 
incurred since this information is currently collected by the local 
agency and submitted on a monthly basis to the State agency for its 
monthly participation report.

4. Sharing Materials With CACFP

    Nutrition education is an important component of WIC nutrition 
services. It is provided to all pregnant, breastfeeding and postpartum 
participants as well as to the parents or caregivers of infant and 
child participants, and when appropriate, to child participants 
directly. As such, the WIC Program develops a variety of nutrition 
education materials for use by State and local cooperators.
    Section 351 of the HHFK Act amends section 17(e)(3)(B) of the CNA 
(42 U.S.C. 1786(e)(3)(B)) to allow local WIC agencies, at the State 
agency's option, to share nutrition education materials with 
institutions participating in the CACFP at no cost, if a written 
materials sharing agreement exists between WIC State or local agencies 
and CACFP institutions. WIC State agencies may initiate a sharing 
agreement with their State-level CACFP counterparts that would apply 
Statewide, or may authorize their local agencies or clinics to initiate 
a sharing agreement at the local level with their local level CACFP 
counterparts.
    This requirement became effective on October 1, 2010, as stipulated 
in the HHFK Act, and was implemented via the March 11, 2011 memorandum, 
``Implementation of the Nondiscretionary, Non-Electronic Benefits 
Transfer-Related Provisions of Public Law 111-296.'' This final rule 
amends Sec.  246.11(c)(3) to allow State agencies the option to allow 
their local agencies or clinics to share nutrition education materials 
with CACFP entities.

5. Recording WIC Rebate Payments

    Section 352(b) of the HHFK Act amends section 17(h)(8) of the CNA 
(42 U.S.C. 1786(h)(8)) to add a new paragraph (K) requiring WIC State 
agencies to report rebate payments received from manufacturers in the 
month in which the payments are received, rather than in the month in 
which the payments are earned. To assist State agencies in making the 
transition to this change in reporting, Section 352(f) of the HHFK Act 
amends section 17(i) of the CNA (42 U.S.C. 1786(i)) to add a new 
paragraph (8) providing for temporary adjustments in spending 
authority.

[[Page 59887]]

    This provision requires State agencies to report rebate payments 
from manufacturers on the FNS-798 (Financial Management and 
Participation Report) in the month in which the payments are received, 
rather than in the month that rebates are earned. This change does not 
affect how rebates are earned and billed on rebate invoices to 
manufacturers, which will continue in accordance with current and 
future rebate contracts. Rather, this change in reporting will assist 
the State agency in more accurately estimating its annual amount of 
rebates, which is a key component in determining its need for food 
funds during the course of the fiscal year.
    This requirement becomes effective on October 1, 2011, as 
stipulated in the HHFK Act. Section 246.14 is modified to incorporate 
the reporting change.

6. New Rebate Bid Solicitation Requirements

    Section 352(c) of the HHFK Act amends section 17(h)(9) of the CNA 
(42 U.S.C. 1786(h)(9)) to add several new requirements for the 
solicitation and billing of all rebates on authorized foods, including 
infant formula, specifically:
    A. The bid solicitation must:
    [cir] Identify the composition of State alliances for the purposes 
of a cost containment measure, and
    [cir] Verify that no additional States shall be added to the State 
alliance between the date of the bid solicitation and the end of the 
contract.
    B. The State agency must have a system to ensure that rebate 
invoices under competitive bidding provide a reasonable estimate or an 
actual count of the number of units sold to WIC participants.
    C. The State agency must publicly open and read all bids aloud on 
the day the bids are due.
    D. The State agency must provide a minimum of 30 days between the 
publication of the solicitation and the date on which the bids are due, 
unless exempted by the Secretary.
    E. The State agency must extend current provisions and requirements 
regarding State alliances for infant formula rebates to all other 
authorized foods for which rebates are sought.
    Rebates are offsets to food costs and allow the Program to serve a 
greater number of participants without increasing the annual 
appropriation of WIC funds by Congress. Infant formula rebates have 
been a very successful cost containment initiative in the WIC Program 
since the mid-1980's. Over the years, State agencies have also 
implemented rebate contracts for other foods, such as infant cereal and 
juice; and more recently, infant foods such as fruit, vegetables and 
meat. A key to the success of rebate contracts is ensuring fair and 
open competition for the contracts.
    The rebate bid solicitation requirements became effective on 
October 1, 2010, as stipulated by the HHFK Act. Section 246.16a is 
modified to incorporate these new requirements.

Notice and Comment

    In accordance with the Secretary's Statement of Policy (36 FR 
13804), it is found and determined with good cause that it is 
unnecessary to engage in the Notice and Comment provisions of 5 U.S.C. 
553 normally required before the adoption of final regulations in an 
FNS-sponsored program. The provisions set forth in this rulemaking are 
nondiscretionary, i.e., the Department has not exercised any authority 
to interpret the statutory provisions beyond the language that is 
specifically provided in the legislation. The nondiscretionary nature 
of the provisions contained in Public Law 111-296 means that notice and 
comment would serve no useful purpose in the promulgation of this 
rulemaking.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility.
    This final rule has been designated not significant under section 
3(f) of Executive Order 12866.

Regulatory Impact Analysis

    This rule has been designated as not significant by the Office of 
Management and Budget; therefore, a Regulatory Impact Analysis is not 
necessary.

Regulatory Flexibility Act

    This final rule has been reviewed with regard to the requirements 
of the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612). Pursuant 
to that review, it has been certified that this rule will not have a 
significant economic impact on a substantial number of small entities.
    This rule incorporates into the regulations governing the Special 
Supplemental Nutrition Program for Women, Infants and Children (WIC) 
several changes set forth in the Healthy, Hunger-Free Kids Act of 2010 
(HHFK Act). The provisions of this rulemaking are applicable to all 
State and local agencies that administer the WIC Program.

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under Section 202 of the UMRA, FNS 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures by State, local, or tribal governments in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. When such a statement is needed for a rule, Section 205 of 
the UMRA generally requires FNS to identify and consider a reasonable 
number of regulatory alternatives and adopt the least costly, more 
cost-effective or least burdensome alternative that achieves the 
objectives of the rule.
    This final rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local or tribal 
governments or the private sector of $100 million or more in any one 
year. Thus, the rule is not subject to the requirements of Sections 202 
and 205 of the UMRA.

Executive Order 12372

    WIC is listed in the Catalog of Federal Domestic Assistance under 
No. 10.557. For the reasons set forth in the final rule at 7 CFR part 
3015, Subpart V and related Notice (48 FR 29115, June 24, 1983), this 
program is included in the scope of Executive Order 12372 that requires 
intergovernmental consultation with State and local officials.

Federalism Summary Impact Statement

    Executive Order 13132 requires Federal agencies to consider the 
impact of their regulatory actions on State and local governments. 
Where such actions have federalism implications, agencies are directed 
to provide a statement for inclusion in the preamble to the regulations 
describing the agency's considerations in terms of the three categories 
called for under Section 6(b)(2)(B) of Executive Order 13132. FNS has 
considered the impact of this rule on State and local governments and

[[Page 59888]]

has determined that this rule does not have federalism implications. 
Therefore, under Section 6(b) of the Executive Order, a federalism 
summary impact statement is not required.

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule is intended to have preemptive effect with 
respect to any State or local laws, regulations, or policies that 
conflict with its provisions or that would otherwise impede its full 
implementation. This rule is not intended to have retroactive effect 
unless so specified in the Dates paragraph of the preamble to the final 
rule. Prior to any judicial challenge to the application of the 
provisions of this rule, all applicable administrative procedures must 
be exhausted.
    In WIC, the administrative procedures are as follows: State and 
local agencies, farmers, farmers' markets, and roadside stands--State 
agency hearing procedures issued pursuant to 7 CFR 246.18; applicants 
and participants--State agency hearing procedures pursuant to 7 CFR 
246.18; sanctions against State agencies (but not claims for repayment 
assessed against a State agency) pursuant to 7 CFR 246.19--
administrative appeal in accordance with 7 CFR 246.16, and procurement 
by State or local agencies--administrative appeal to the extent 
required by 7 CFR 3016.36.

Civil Rights Impact Analysis

    FNS has reviewed this rule in accordance with Departmental 
Regulations 4300-4, ``Civil Rights Impact Analysis,'' and 1512-1, 
``Regulatory Decision Making Requirements.'' After a careful review of 
the rule's intent and provisions, FNS has determined that this rule is 
not intended to limit or reduce in any way the ability of protected 
classes of individuals to receive benefits in the WIC Program. Federal 
WIC regulations specifically prohibit State agencies that administer 
the WIC Program, and their cooperators, from engaging in actions that 
discriminate against any individual in any of the protected classes 
(see 7 CFR 246.8 for the nondiscrimination policy in the WIC Program). 
Where State agencies have options, and they choose to implement a 
certain provision, they must implement it in such a way that it 
complies with the WIC Program regulations set forth at Sec.  246.8.

Executive Order 13175--Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 requires Federal agencies to consult and 
coordinate with Tribes on a government-to-government basis on policies 
that have Tribal implications, including regulations, legislative 
comments or proposed legislation, and other policy statements or 
actions that have substantial direct effects on one or more Indian 
tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes. USDA will respond in a timely 
and meaningful manner to all Tribal government requests for 
consultation concerning this rule and will provide additional venues, 
such as webinars and teleconferences, to host periodic collaborative 
conversations with Tribal officials or their designees concerning ways 
to improve this rule in Indian country. We are not aware of any current 
Tribal laws that could be in conflict with this final rule.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR 
part 1320) requires that the Office of Management and Budget (OMB) 
approve all collections of information by a Federal agency from the 
public before they can be implemented. Respondents are not required to 
respond to any collection of information unless it displays a current, 
valid OMB control number. While some of the provisions of this rule are 
related to the current collection of information for the WIC Program, 
this final rule has no new information collection requirements. The 
information collection burdens associated with collecting local agency 
breastfeeding data and the recording of rebates in this final rule have 
been previously approved under OMB No. 0584-0045, WIC Financial 
Management and Participation Report with Addendum.

E-Government Act Compliance

    FNS is committed to complying with the E-Government Act of 2002 to 
promote the use of the internet and other information technologies to 
provide increased opportunities to provide for citizen access to 
government information and services, and for other purposes. State Plan 
amendments regarding the implementation of the provisions contained in 
this rule, as is the case with the entire State Plan, may be 
transmitted electronically by the State agency to FNS. Also, State 
agencies may provide WIC Program information, as well as their 
financial reports, to FNS electronically.

List of Subjects in 7 CFR Part 246

    Food assistance programs, Food donations, Grant programs--Social 
programs, Indians, Nutrition education, Public assistance programs, 
WIC.

    For reasons discussed above, 7 CFR part 246 is amended as follows:

PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS 
AND CHILDREN

0
1. The authority citation for part 246 continues to read as follows:

    Authority: 7 U.S.C. 1786.


Sec.  246.1  [Amended]

0
2. Section 246.1 is amended by adding the phrase ``, including 
breastfeeding promotion and support,'' after the word ``education'' in 
the third sentence.


Sec.  246.3  [Amended]

0
3. Section 246.3 is amended in paragraph (e) by adding the phrase 
``breastfeeding promotion and support,'' after the word ``education,'' 
in the first sentence.

0
4. In Sec.  246.4:
0
a. Revise paragraph (a)(9);
0
b. Amend paragraph (a)(11)(ii) by adding the phrase ``, including 
breastfeeding promotion and support,'' after the word ``education'' in 
the first sentence; and
0
c. Redesignate paragraphs (a)(19) through (a)(26) as paragraphs (a)(20) 
through (a)(27), and add a new paragraph (a)(19).
    The revisions and additions read as follows:


Sec.  246.4  State plan.

    (a) * * *
    (9) The State agency's nutrition education goals and action plans 
to include:
    (i) A description of the methods that will be used to provide drug 
and other harmful substance abuse information, to promote and support 
breastfeeding, and to meet the special nutrition education needs of 
migrant farmworkers and their families, Indians, and homeless persons.
    (ii) State agencies have the option to provide nutrition education 
materials to institutions participating in the CACFP at no cost, as 
long as a written agreement for sharing such materials is in place 
between the relevant WIC and CACFP entities. State agencies may 
initiate a sharing agreement with their State-level CACFP counterparts 
that would apply statewide, or may

[[Page 59889]]

authorize their local agencies or clinics to initiate a sharing 
agreement at the local level with their local level CACFP counterparts.
* * * * *
    (19) The State agency's plan to ensure that participants receive 
required health and nutrition assessments when certified for a period 
of greater than six months.
* * * * *


Sec.  246.6  [Amended]

0
5. In Sec.  246.6 paragraph (b)(6) is amended by adding the phrase ``, 
including breastfeeding promotion and support,'' after the word 
``services''.

0
6. In Sec.  246.7:
0
a. Revise the fourth sentence in paragraph (e);
0
b. Revise paragraph (g)(1)(v) to read as set forth below;
0
c. Amend paragraph (j)(2)(iii) by removing the phrase ``and nutrition 
education'' and adding in its place the phrase ``, nutrition education 
and breastfeeding support''; and
0
d. Amend paragraph (m)(1)(i)(C) by removing the phrase ``and nutrition 
education'' and adding in its place the phrase ``, nutrition education 
and breastfeeding support'';
0
e. Amend paragraph (m)(4) by adding the phrase ``, including 
breastfeeding promotion and support,'' after the word ``education''.
    The revisions read as follows:


Sec.  246.7  Certification of participants.

* * * * *
    (e) * * * Nutritional risk data shall be documented in the 
participant's file and shall be used to assess an applicant's 
nutritional status and risk; tailor the food package to address 
nutritional needs; design appropriate nutrition education, including 
breastfeeding promotion and support; and make referrals to health and 
social services for follow-up, as necessary and appropriate.
* * * * *
    (g) * * *
    (1) * * *

------------------------------------------------------------------------
             A/an:                         Will be certified:
------------------------------------------------------------------------
 
                              * * * * * * *
 (v) Child....................  Approximately every six months ending
                                 with the last day of the month in which
                                 a child reaches his/her fifth birthday.
                                 The State agency may permit its local
                                 agencies to certify a child for a
                                 period of up to one year, provided the
                                 local agency ensures that the child
                                 receives the required health and
                                 nutrition assessments, as set forth in
                                 Sec.   246.11(e)(3).
------------------------------------------------------------------------

* * * * *

0
7. In Sec.  246.11:
0
a. Amend paragraphs (a)(1), and (b) introductory text, by adding the 
phrase ``including breastfeeding promotion and support,'' after the 
phrase ``Nutrition education'' wherever it appears;
0
b. Amend paragraph (a)(2) by adding the phrase ``, including 
breastfeeding promotion and support, as appropriate,'' after the word 
``education'' in the first sentence;
0
c. Amend paragraph (c) introductory text by adding the phrase ``, 
including breastfeeding promotion and support,'' after the word 
``responsibilities'';
0
d. Add new paragraph (c)(8);
0
e. Amend paragraph (d) introductory text by adding the phrase ``, 
including breastfeeding promotion and support,'' after the word 
``responsibilities'';
0
f. Revise the first sentence in paragraph (d)(1);
0
g. Revise the first sentence in paragraph (d)(2);
0
h. Amend paragraph (e)(1) by adding the phrase ``including 
breastfeeding promotion and support,'' after the phrase ``nutrition 
education'' ; and
0
i. Revise paragraph (e)(3).
    The revisions and additions read as follows:


Sec.  246.11  Nutrition education.

* * * * *
    (c) * * *
    (8) Determine if local agencies or clinics can share nutrition 
educational materials with institutions participating in the Child and 
Adult Care Food Program established under section 17 of the Richard B. 
Russell National School Lunch Act (42 U.S.C. 1766) at no cost to that 
program, if a written materials sharing agreement exists between the 
relevant agencies.
    (d) * * *
    (1) Make nutrition education, including breastfeeding promotion and 
support, available or enter into an agreement with another agency to 
make nutrition education available to all adult participants, and to 
parents or caretakers of infant and child participants, and whenever 
possible and appropriate, to child participants.* * *
    (2) Develop an annual local agency nutrition education plan, 
including breastfeeding promotion and support, consistent with the 
State agency's nutrition education component of Program operations and 
in accordance with this part and FNS guidelines. * * *
    (e) * * *
    (3) Nutrition education contacts shall be made available at a 
quarterly rate to parents or caretakers of infant and child 
participants certified for a period in excess of six months. Nutrition 
education contacts shall be scheduled on a periodic basis by the local 
agency, but such contacts do not necessarily need to take place in each 
quarter of the certification period.
* * * * *


Sec.  246.12  [Amended]

0
8. Section 246.12(d) is amended by adding the phrase ``, and 
breastfeeding counseling ``after the word ``education''.

0
9. In Sec.  246.14:
0
a. Amend paragraph (c)(1) by adding the phrase ``, including 
breastfeeding promotion and support, '' after the word ``education'' in 
the eleventh sentence;
0
b. Add a new paragraph (f).
    The addition reads as follows:


Sec.  246.14  Program costs.

* * * * *
    (f) Use of funds received as rebates from manufacturers. The State 
agency must credit and report rebate payments received from 
manufacturers in the month in which the payments are received.

0
10. In Sec.  246.16a:
0
a. Revise the section heading;
0
b. Redesignate paragraphs (c)(1) through (c)(8) as paragraphs (c)(2) 
through (c)(9);
0
c. Remove introductory text of paragraph (c) and add a new paragraph 
(c)(1);
0
d. Amend newly designated paragraph (c)(3) by adding a third sentence; 
and
0
e. Revise paragraphs (g) and (k).
    The additions and revisions read as follows:


Sec.  246.16a  Infant formula and authorized foods cost containment.

* * * * *
    (c) What is the single-supplier competitive system?--(1) Under the 
single-supplier competitive system, a State agency solicits sealed bids 
from infant formula manufacturers to supply and provide a rebate for 
infant formulas. The State agency must conduct the

[[Page 59890]]

procurement in a manner that maximizes full and open competition 
consistent with the requirements of this section. A State agency must:
    (i) Provide a minimum of 30 days between the publication of the 
solicitation and the date on which the bids are due, unless exempted by 
the Secretary; and
    (ii) Publicly open and read all bids aloud on the day the bids are 
due.
* * * * *
    (c) * * *
    (3) * * * The bid solicitation must identify the composition of the 
State alliances for the purpose of a cost containment measure, and 
verify that no additional State shall be added to the State alliance 
between the date of the bid solicitation and the end of the contract. * 
* *
* * * * *
    (g) May a State agency implement cost containment systems for other 
supplemental foods? Yes, when a State agency finds that it is 
practicable and feasible to implement a cost containment system for any 
WIC food other than infant formula. The State agency must:
    (1) Provide notification to FNS by means of the State agency's 
State Plan.
    (2) Comply with paragraphs (c)(2) and (k) of this section.
    (3) Provide a minimum of 30 days between the publication of the 
solicitation and the date on which the bids are due, unless exempted by 
the Secretary. The State must publicly open and read all bids aloud on 
the day the bids are due.
    (4) Issue separate solicitations for authorized foods if any 
alliance served a monthly average of more than 100,000 infants during 
the preceding 12-month period.
* * * * *
    (k) What are the requirements for infant formula and authorized 
food rebate invoices? A State agency must have a system in place that 
ensures infant formula and authorized food rebate invoices, under 
competitive bidding, provide a reasonable estimate or an actual count 
of the number of units purchased by participants in the program.
* * * * *


Sec.  246.19  [Amended]

0
11. Section 246.19(b)(2) is amended by adding the phrase 
``breastfeeding promotion and support,'' after the word ``education,'' 
in the first sentence.

0
12. In Sec.  246.25:
0
a. Amend paragraph (a)(1) by adding the phrase ``including 
breastfeeding promotion and support,'' after the word ``education,'';
0
b. Redesignate paragraphs (b)(1)(i)(C) and (D) as paragraphs 
(b)(1)(i)(D) and (E), and add a new paragraph (b)(1)(i)(C); and
0
c. Add new paragraph (b)(2)(iii).
    The additions read as follows:


Sec.  246.25  Records and reports.

    (b) * * *
    (1) * * *
    (i) * * *
    (C) Actual and projected rebate payments received from 
manufacturers.
* * * * *
    (2) * * *
    (iii) The State agency must submit local agency breastfeeding 
participation data on an annual basis to FNS.
* * * * *

    Dated: September 20, 2011.
Audrey Rowe,
Administrator, Food and Nutrition Service.
[FR Doc. 2011-24722 Filed 9-27-11; 8:45 am]
BILLING CODE 3410-30-P
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