80 FR 23032 - Final Priority; National Institute on Disability, Independent Living, and Rehabilitation Research; Disability and Rehabilitation Research Projects Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 80, Issue 79 (April 24, 2015)
Administration for Community Living
Federal Register Volume 80, Issue 79 (April 24, 2015)
| Page Range | 23032-23034 | |
| FR Document | 2015-09606 |
[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)] [Notices] [Pages 23032-23034] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09606] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Final Priority; National Institute on Disability, Independent Living, and Rehabilitation Research; Disability and Rehabilitation Research Projects Program AGENCY: Administration for Community Living, Department of Health and Human Services. ACTION: Final priority. ----------------------------------------------------------------------- CFDA Number: 84.133A-7. SUMMARY: The Administrator of the Administration for Community Living announces a priority for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, we announce a priority for a DRRP on Promoting Universal Design in the Built Environment. The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to strengthened evidence-base for UD standards and strategies and improved access to the built environment for individuals with disabilities. DATES: Effective Date: This priority is effective May 26, 2015. FOR FURTHER INFORMATION CONTACT: Marlene Spencer, U.S. Department of Health And Human Services, 400 Maryland Avenue SW., Room 5133, Potomac Center Plaza (PCP), Washington, DC 20202-2700. Telephone: (202) 245- 7532 or by email: [email protected]. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1- 800-877-8339. SUPPLEMENTARY INFORMATION: Purpose of Program The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act). Disability and Rehabilitation Research Projects The purpose of NIDILRR's DRRPs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to improve the effectiveness of services authorized under the Rehabilitation Act by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most significant disabilities. DRRPs carry out one or more of the following types of activities, as specified and defined in 34 CFR 350.13 through 350.19: research, training, demonstration, development, utilization, dissemination, and technical assistance. An applicant for assistance under this program must demonstrate in its application how it will address, in whole or in part, the needs of individuals with disabilities from minority backgrounds (34 CFR 350.40(a)). The approaches an applicant may take to meet this requirement are found in 34 CFR 350.40(b). Additional information on the DRRP program can be found at: www.ed.gov/rschstat/research/pubs/res-program.html#DRRP. Program Authority: 29 U.S.C. 762(g) and 764(a). Applicable Program Regulations: 34 CFR part 350. We published a notice of proposed priority (NPP) for this program in the Federal Register on February 25, 2015 (80 FR 10099). That notice contained background information and our reasons for proposing the particular priority. There are differences between the proposed priority and this final priority. Public Comment: In response to our invitation in the notice of proposed priority, six parties submitted comments on the proposed priority. Generally, we do not address technical and other minor changes. In addition, we do not address general comments that raised concerns not directly related to the proposed priority. Analysis of the Comments and Changes: An analysis of the comments and of any changes in the priority since publication of the NPP follows. Comment: Two commenters noted that research on the costs of, as well as the benefits of and savings from universal design (UD) applications, can facilitate future adoption of UD principles. These commenters suggested that the priority be revised to require such research on the costs and benefits of UD. Discussion: Paragraph (a) requires research toward developing evidence-based practices for UD implementation. Research under this paragraph could include analysis of the costs, benefits, and savings associated with UD applications. Nothing in the priority precludes such research. NIDILRR does not wish to further specify the research requirements as suggested by the commenters and thereby limit the breadth of research topics proposed under this priority. However, we do agree that findings from analyses of the costs, benefits, and savings associated with UD implementation could help facilitate further adoption of UD principles into mainstream architecture and the development and construction of built environments. Changes: We have modified the priority to include analyses of the costs, savings, and benefits of UD implementation as an optional activity that applicants may propose. The peer [[Page 23033]] review process will determine the merits of each proposal. Comment: One commenter requested that NIDILRR refer to individuals with different abilities, instead of individuals with disabilities. Discussion: NIDILRR aims to sponsor research that is directly applicable to, and serves, the needs of individuals with disabilities. While we understand that UD applications are intended to be beneficial to people with a wide range of different abilities, NIDILRR's aim is to generate new knowledge, products, and environments that can be used to provide full opportunities and accommodations for its citizens with disabilities. NIDILRR's applicants and stakeholders are accustomed to our focus on improving the outcomes of individuals with disabilities through research and development, and we think that we should be consistent in our terminology. Therefore we will continue to directly refer to people with disabilities as our primary stakeholders. Changes: None. Comment: One Commenter suggested that NIDILRR modify the priority to require the DRRP to engage in design and construction of practical and tangible physical projects that incorporate and demonstrate universal design concepts. Discussion: NIDILRR's intended outcome of this DRRP is further adoption of universal design principles into mainstream architecture and the development and construction of built environments. We will contribute to this outcome by sponsoring research, training, technical assistance, as well as the development of new UD curricula and new UD standards and guidelines. Through these activities we will contribute to much wider implementation of universally designed facilities, outdoor environments, and housing. We do not intend the DRRP's limited resources to be used for the design or construction of a small number of universally designed projects. Changes: None. Comment: One commenter suggested that NIDILRR revise the priority to specify that Universal Design incorporates the concept of ``healthy indoor environmental quality'' (IEQ) to make buildings healthier for everyone and more accessible for people with chemical or electrical sensitivities. Discussion: Nothing in the priority precludes applicants from including IEQ in its conceptualization of universal design, or in its work to facilitate the further adoption of universal design principles into the mainstream architecture and the development and construction of built environments. However, NIDILRR does not have a sufficient basis for further specifying the purposefully broad, long-standing principles of UD that the DRRP is intended to promote. Changes: None. Comment: One commenter recommended that NIDILRR modify the priority to include specific reference to the ``Goals of Universal Design,'' as published by Steinfeld and Maisel in 2012. This commenter suggested that these goals can be used by the DRRP to define and measure outcomes of UD practice and to frame the transfer of knowledge about UD into practice. Discussion: The intended outcome of this priority is to expand UD practice into the mainstream of design, architecture, and construction of built environments. Nothing in the priority precludes applicants from using the ``Goals of Universal Design'' to frame or guide their work toward this outcome. However, NIDILRR does not wish to further specify the conceptual or measurement framework that is to be used by the DRRP, because we do not want to limit the breadth of approaches that various applicants may propose to meet this critical need. The peer review process will determine the merits of each proposal. Changes: None. Final Priority The Administrator of the Administration for Community Living establishes a priority for a DRRP on Promoting Universal Design in the Built Environment. The intended outcome of the DRRP on Universal Design is further adoption of universal design principles into mainstream architecture and the development and construction of built environments. The DRRP must contribute to this outcome by: (a) Conducting research activities toward developing evidence-based practices for UD implementation in commercial and private facilities, outdoor environments, and housing. This research may include analyses of the costs, benefits, and savings associated with universal design implementation. (b) Creating measurable UD standards and guidelines to facilitate the implementation of UD principles in commercial and private facilities, outdoor environments, and housing. (c) Developing and promoting curricula on UD for university-level architecture, engineering, and design students. (d) Providing training and technical assistance to designers, architects, and builders to incorporate UD principles and features into their buildings, projects, and communities. (e) Providing training and technical assistance to NIDILRR's engineering and assistive technology grantees to incorporate UD strategies and standards into development projects serving the needs of individuals with disabilities and the broader population. (f) Partnering with relevant stakeholders in carrying out all DRRP activities. Stakeholders include but are not limited to: individuals with disabilities, professional organizations that teach design principles, researchers, engineers, planners, designers, developers, architects, and builders. Types of Priorities When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows: Absolute priority: Under an absolute priority, we consider only applications that meet the priority (45 CFR 75). Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (45 CFR 75); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (45 CFR 75). Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (45 CFR 75). This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements. Note: This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register. Executive Orders 12866 and 13563 Regulatory Impact Analysis Under Executive Order 12866, the Secretary must determine whether this regulatory action is ``significant'' and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a ``significant [[Page 23034]] regulatory action'' as an action likely to result in a rule that may-- (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an ``economically significant'' rule); (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impacts of entitlement 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 stated in the Executive order. This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866. We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency-- (1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify); (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account--among other things and to the extent practicable--the costs of cumulative regulations; (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and (5) Identify and assess available alternatives to direct regulation, including economic incentives--such as user fees or marketable permits--to encourage the desired behavior, or provide information that enables the public to make choices. Executive Order 13563 also requires an agency ``to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.'' The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include ``identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.'' We are issuing this final priority only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Administration for Community Living (ACL), Department of Health and Human Services believes that this regulatory action is consistent with the principles in Executive Order 13563. We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions. In accordance with both Executive orders, ACL assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the ACL's programs and activities. The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years, as projects similar to the one envisioned by the final priority have been completed successfully, and the proposed priority will generate new knowledge through research. The new DRRP will generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities in the areas of community living and participation, employment, and health and function. Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of ACL published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department. Dated: April 21, 2015. John Tschida, Director, National Institute on Disability, Independent Living, and Rehabilitation Research. [FR Doc. 2015-09606 Filed 4-23-15; 8:45 am] BILLING CODE 4154-01-P
![23032 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices
VII. Agency Contact take this action to focus research whole or in part, the needs of
If you use a TDD or a TTY, call the attention on an area of national need. individuals with disabilities from
Federal Relay Service (FRS), toll free, at We intend for this priority to contribute minority backgrounds (34 CFR
1–800–877–8339. to strengthened evidence-base for UD 350.40(a)). The approaches an applicant
standards and strategies and improved may take to meet this requirement are
VIII. Other Information access to the built environment for found in 34 CFR 350.40(b). Additional
Electronic Access to This Document: individuals with disabilities. information on the DRRP program can
The official version of this document is DATES: Effective Date: This priority is be found at: www.ed.gov/rschstat/
the document published in the Federal effective May 26, 2015. research/pubs/res-program.html#DRRP.
Register. Free Internet access to the FOR FURTHER INFORMATION CONTACT: Program Authority: 29 U.S.C. 762(g) and
official edition of the Federal Register Marlene Spencer, U.S. Department of 764(a).
and the Code of Federal Regulations is Health And Human Services, 400
available via the Federal Digital System Maryland Avenue SW., Room 5133, Applicable Program Regulations: 34
at: www.gpo.gov/fdsys. At this site you Potomac Center Plaza (PCP), CFR part 350.
can view this document, as well as all We published a notice of proposed
Washington, DC 20202–2700.
other documents of this Department priority (NPP) for this program in the
Telephone: (202) 245–7532 or by email:
published in the Federal Register, in Federal Register on February 25, 2015
marlene.spencer@acl.hhs.gov.
text or Adobe Portable Document (80 FR 10099). That notice contained
If you use a telecommunications
Format (PDF). To use PDF you must background information and our reasons
device for the deaf (TDD) or a text
have Adobe Acrobat Reader, which is for proposing the particular priority.
telephone (TTY), call the Federal Relay
available free at the site. There are differences between the
Service (FRS), toll free, at 1–800–877–
You may also access documents of the proposed priority and this final priority.
8339. Public Comment: In response to our
Department published in the Federal
SUPPLEMENTARY INFORMATION: invitation in the notice of proposed
Register by using the article search
feature at: www.federalregister.gov. priority, six parties submitted comments
Purpose of Program
Specifically, through the advanced on the proposed priority.
The purpose of the Disability and Generally, we do not address
search feature at this site, you can limit Rehabilitation Research Projects and technical and other minor changes. In
your search to documents published by Centers Program is to plan and conduct addition, we do not address general
the Department. research, demonstration projects, comments that raised concerns not
Dated: April 21, 2015. training, and related activities, directly related to the proposed priority.
John Tschida, including international activities, to Analysis of the Comments and
Director, National Institute on Disability, develop methods, procedures, and Changes: An analysis of the comments
Independent Living, and Rehabilitation rehabilitation technology that maximize and of any changes in the priority since
Research. the full inclusion and integration into publication of the NPP follows.
[FR Doc. 2015–09598 Filed 4–23–15; 8:45 am] society, employment, independent Comment: Two commenters noted
BILLING CODE 4154–01–P living, family support, and economic that research on the costs of, as well as
and social self-sufficiency of individuals the benefits of and savings from
with disabilities, especially individuals universal design (UD) applications, can
DEPARTMENT OF HEALTH AND with the most severe disabilities, and to facilitate future adoption of UD
HUMAN SERVICES improve the effectiveness of services principles. These commenters suggested
authorized under the Rehabilitation Act that the priority be revised to require
Administration for Community Living of 1973, as amended (Rehabilitation such research on the costs and benefits
Act). of UD.
Final Priority; National Institute on
Discussion: Paragraph (a) requires
Disability, Independent Living, and Disability and Rehabilitation Research research toward developing evidence-
Rehabilitation Research; Disability and Projects based practices for UD implementation.
Rehabilitation Research Projects The purpose of NIDILRR’s DRRPs, Research under this paragraph could
Program which are funded through the Disability include analysis of the costs, benefits,
AGENCY: Administration for Community and Rehabilitation Research Projects and savings associated with UD
Living, Department of Health and and Centers Program, is to improve the applications. Nothing in the priority
Human Services. effectiveness of services authorized precludes such research. NIDILRR does
ACTION: Final priority. under the Rehabilitation Act by not wish to further specify the research
developing methods, procedures, and requirements as suggested by the
CFDA Number: 84.133A–7. rehabilitation technologies that advance commenters and thereby limit the
SUMMARY: The Administrator of the a wide range of independent living and breadth of research topics proposed
Administration for Community Living employment outcomes for individuals under this priority. However, we do
announces a priority for the Disability with disabilities, especially individuals agree that findings from analyses of the
and Rehabilitation Research Projects with the most significant disabilities. costs, benefits, and savings associated
(DRRPs) Program administered by the DRRPs carry out one or more of the with UD implementation could help
National Institute on Disability, following types of activities, as specified facilitate further adoption of UD
Independent Living, and Rehabilitation and defined in 34 CFR 350.13 through principles into mainstream architecture
tkelley on DSK3SPTVN1PROD with NOTICES
Research (NIDILRR). Specifically, we 350.19: research, training, and the development and construction
announce a priority for a DRRP on demonstration, development, of built environments.
Promoting Universal Design in the Built utilization, dissemination, and technical Changes: We have modified the
Environment. The Administrator of the assistance. priority to include analyses of the costs,
Administration for Community Living An applicant for assistance under this savings, and benefits of UD
may use this priority for competitions in program must demonstrate in its implementation as an optional activity
fiscal year (FY) 2015 and later years. We application how it will address, in that applicants may propose. The peer
VerDate Sep<11>2014 17:30 Apr 23, 2015 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1](https://thefederalregister.org/doc/80_FR_23111/page/1.svg)
![23034 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices
regulatory action’’ as an action likely to Information and Regulatory Affairs of your search to documents published by
result in a rule that may— OMB has emphasized that these the Department.
(1) Have an annual effect on the techniques may include ‘‘identifying Dated: April 21, 2015.
economy of $100 million or more, or changing future compliance costs that John Tschida,
adversely affect a sector of the economy, might result from technological
Director, National Institute on Disability,
productivity, competition, jobs, the innovation or anticipated behavioral Independent Living, and Rehabilitation
environment, public health or safety, or changes.’’ Research.
State, local, or tribal governments or We are issuing this final priority only
[FR Doc. 2015–09606 Filed 4–23–15; 8:45 am]
communities in a material way (also on a reasoned determination that its
BILLING CODE 4154–01–P
referred to as an ‘‘economically benefits justify its costs. In choosing
significant’’ rule); among alternative regulatory
(2) Create serious inconsistency or approaches, we selected those
DEPARTMENT OF HEALTH AND
otherwise interfere with an action taken approaches that maximize net benefits.
HUMAN SERVICES
or planned by another agency; Based on the analysis that follows, the
(3) Materially alter the budgetary Administration for Community Living Food and Drug Administration
impacts of entitlement grants, user fees, (ACL), Department of Health and
or loan programs or the rights and Human Services believes that this [Docket No. FDA–2014–E–0130]
obligations of recipients thereof; or regulatory action is consistent with the
(4) Raise novel legal or policy issues principles in Executive Order 13563. Determination of Regulatory Review
arising out of legal mandates, the We also have determined that this Period for Purposes of Patent
President’s priorities, or the principles regulatory action does not unduly Extension; FLUBLOK
stated in the Executive order. interfere with State, local, and tribal AGENCY: Food and Drug Administration,
This final regulatory action is not a governments in the exercise of their HHS.
significant regulatory action subject to governmental functions. ACTION: Notice.
review by OMB under section 3(f) of In accordance with both Executive
Executive Order 12866. orders, ACL assessed the potential costs SUMMARY: The Food and Drug
We have also reviewed this final and benefits, both quantitative and Administration (FDA) has determined
regulatory action under Executive Order qualitative, of this regulatory action. the regulatory review period for
13563, which supplements and The potential costs are those resulting FLUBLOK and is publishing this notice
explicitly reaffirms the principles, from statutory requirements and those of that determination as required by
structures, and definitions governing we have determined as necessary for law. FDA has made the determination
regulatory review established in administering the ACL’s programs and because of the submission of an
Executive Order 12866. To the extent activities. application to the Director of the U.S.
permitted by law, Executive Order The benefits of the Disability and Patent and Trademark Office (USPTO),
13563 requires that an agency— Rehabilitation Research Projects and Department of Commerce, for the
(1) Propose or adopt regulations only Centers Program have been well extension of a patent which claims that
upon a reasoned determination that established over the years, as projects human biological product.
their benefits justify their costs similar to the one envisioned by the ADDRESSES: Submit electronic
(recognizing that some benefits and final priority have been completed comments to http://
costs are difficult to quantify); successfully, and the proposed priority www.regulations.gov. Submit written
(2) Tailor its regulations to impose the will generate new knowledge through petitions (two copies are required) and
least burden on society, consistent with research. The new DRRP will generate, written comments to the Division of
obtaining regulatory objectives and disseminate, and promote the use of Dockets Management (HFA–305), Food
taking into account—among other things new information that would improve and Drug Administration, 5630 Fishers
and to the extent practicable—the costs outcomes for individuals with Lane, Rm. 1061, Rockville, MD 20852.
of cumulative regulations; disabilities in the areas of community Submit petitions electronically to
(3) In choosing among alternative living and participation, employment, http://www.regulations.gov at Docket
regulatory approaches, select those and health and function. No. FDA–2013–S–0610.
approaches that maximize net benefits Electronic Access to This Document:
FOR FURTHER INFORMATION CONTACT:
(including potential economic, The official version of this document is
the document published in the Federal Beverly Friedman, Office of
environmental, public health and safety,
Register. Free Internet access to the Management, Food and Drug
and other advantages; distributive
official edition of the Federal Register Administration, 10001 New Hampshire
impacts; and equity);
(4) To the extent feasible, specify and the Code of Federal Regulations is Ave., Hillandale Campus, Rm. 3180,
performance objectives, rather than the available via the Federal Digital System Silver Spring, MD 20993, 301–796–
behavior or manner of compliance a at: www.gpo.gov/fdsys. At this site you 7900.
regulated entity must adopt; and can view this document, as well as all SUPPLEMENTARY INFORMATION: The Drug
(5) Identify and assess available other documents of ACL published in Price Competition and Patent Term
alternatives to direct regulation, the Federal Register, in text or Adobe Restoration Act of 1984 (Pub. L. 98–417)
including economic incentives—such as Portable Document Format (PDF). To and the Generic Animal Drug and Patent
user fees or marketable permits—to use PDF you must have Adobe Acrobat Term Restoration Act (Pub. L.100–670)
encourage the desired behavior, or Reader, which is available free at the generally provide that a patent may be
tkelley on DSK3SPTVN1PROD with NOTICES
provide information that enables the site. extended for a period of up to 5 years
public to make choices. You may also access documents of the so long as the patented item (human
Executive Order 13563 also requires Department published in the Federal drug product, animal drug product,
an agency ‘‘to use the best available Register by using the article search medical device, food additive, or color
techniques to quantify anticipated feature at: www.federalregister.gov. additive) was subject to regulatory
present and future benefits and costs as Specifically, through the advanced review by FDA before the item was
accurately as possible.’’ The Office of search feature at this site, you can limit marketed. Under these acts, a product’s
VerDate Sep<11>2014 17:30 Apr 23, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1](https://thefederalregister.org/doc/80_FR_23111/page/3.svg)
Document Created: 2015-12-16 08:43:32
Document Modified: 2015-12-16 08:43:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Final priority. | |
| Contact | Marlene Spencer, U.S. Department of Health And Human Services, 400 Maryland Avenue SW., Room 5133, Potomac Center Plaza (PCP), Washington, DC 20202-2700. Telephone: (202) 245- 7532 or by email: [email protected] | |
| FR Citation | 80 FR 23032 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR