80 FR 46990 - Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 151 (August 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 151 (August 6, 2015)
| Page Range | 46990-46993 | |
| FR Document | 2015-19244 |
[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)] [Notices] [Pages 46990-46993] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19244] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-D-0500] (formerly Docket No. 2004D-0042) Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Revision 2); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled ``Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.'' We are reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this reissued revised draft guidance before it [[Page 46991]] begins work on the final version of the guidance, submit either electronic or written comments on the reissued revised draft guidance by October 5, 2015. Submit either electronic or written comments on the proposed collection of information by October 5, 2015. ADDRESSES: Submit written requests for single copies of the reissued revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave. Hillandale Building, 4th Floor, Silver Spring, MD 20993- 0002; to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002; or to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft guidance document. Submit electronic comments on the reissued revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs: Julie Chronis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-1200. Regarding human prescription biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding animal prescription drugs: Thomas Moskal, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. Rockville, MD 20855-2792, 240-402-6251. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the reissuance of a revised draft guidance for industry entitled ``Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.'' We are reissuing the revised draft guidance to incorporate animal prescription drugs; there are no other revisions to the revised draft guidance for industry issued February 9, 2015 (80 FR 6998). As stated previously, the revised draft guidance updates prior FDA policy and describes the Agency's current thinking regarding the brief summary requirement for consumer-directed print prescription drug advertisements. Specifically, the revised draft guidance includes recommendations for developing a consumer brief summary and notes that, so long as firms include appropriate information in a print advertisement as outlined in the revised draft guidance, FDA does not intend to object for a failure to include certain other information. Additionally, the revised draft guidance provides new recommendations regarding the adequate directions for use requirement for consumer-directed print promotional labeling for prescription drug products. Although the requirement in 21 CFR 201.100(d) and 21 CFR 201.105(d) for firms to provide adequate information for use is generally fulfilled by providing the full FDA-approved package insert (PI), the revised draft guidance provides that, in exercising its enforcement discretion, FDA does not intend to object for failure to include the full PI with consumer-directed print promotional labeling pieces if firms include the appropriate information as outlined in the revised draft guidance, i.e., the same information in the consumer brief summary. This recommendation is designed to standardize the information consumers receive in print prescription drug product advertisements and promotional labeling and to make information more understandable to consumers. FDA issued a draft guidance in the Federal Register of February 10, 2004 (69 FR 6308), entitled ``Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.'' FDA requested comments on whether the draft guidance provided sufficient guidance on the content of the consumer brief summary and also requested research results on potential formats for the consumer brief summary. Comments, suggestions, and research were submitted to Docket No. 2004D-0042 and were carefully analyzed and considered before developing the revised draft guidance. FDA issued the revised draft guidance in the Federal Register of February 9, 2015, giving interested parties an opportunity to submit comments by May 11, 2015. We are reissuing the revised draft guidance to incorporate animal prescription drugs; there are no other revisions to the revised draft guidance issued February 2015. The revised draft guidance incorporates information from recent social science research, clarifies the risk information that should be included in the consumer brief summary, and recommends several formatting options for this information. The revised draft guidance also recommends the use of consumer-friendly language and visual techniques to improve accessibility for consumers. Additionally, the revised draft guidance recommends that firms not disseminate the full PI to fulfill the requirements in Sec. 201.100(d) for consumer- directed print promotional labeling for prescription drugs. Rather, the revised draft guidance recommends that firms provide the same content and format created for the consumer brief summary. FDA is issuing the revised guidance as a draft to allow for public comment on the recommendations. The reissued revised draft guidance is being issued consistent with FDA's good guidance practices regulations (21 CFR 10.115). The reissued revised draft guidance, when finalized, will represent FDA's current thinking on the brief summary and adequate directions for use requirements. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. The revised draft guidance also refers to previously approved collection of information found in FDA regulations. [[Page 46992]] With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors (firms) of human and animal prescription drug products, including biological products for use in humans. Burden Estimate: The reissued revised draft guidance pertains to the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for human and animal prescription drugs when print materials are directed toward consumers. The reissued revised draft guidance, in part, explains FDA's current policy position that FDA does not intend to object for failure to include the entire PI to fulfill the requirements of Sec. Sec. 201.100(d) and 201.105(d)(1) for promotional labeling pieces directed toward consumers, if firms instead provide information on the most serious and the most common risks associated with the product, while omitting less important information. Specifically, FDA recommends that any Boxed Warning, all Contraindications, certain information regarding Warnings and Precautions (i.e., the most clinically significant information from the Warnings and Precautions section of the PI, information that would affect a decision to prescribe or take a drug, monitoring or laboratory tests that may be needed, special precautions not set forth in other parts of the PI, and measures that can be taken to prevent or mitigate harm), and the most frequently occurring Adverse Reactions should be included. Furthermore, FDA recommends that information should include the indication for the use being promoted. Information regarding patient directives (such as ``discuss with your health care provider any pre- existing conditions'' or ``tell your health care provider if you are taking any medications'') should also be included. Other types of information may be included if relevant to the drug or specific indication referred to in the promotional material(s). A statement should be included that more comprehensive information can be obtained from various sources, including the firm. Thus, the reissued revised draft guidance recommends that firms disclose certain information to others in place of the PI to fulfill the requirements in Sec. Sec. 201.100(d) and 201.105(d). This ``third- party disclosure'' constitutes a ``collection of information'' under the PRA. FDA estimates that approximately 400 firms subject to Sec. 201.100(d) disseminate 24,000 consumer-directed print promotional labeling pieces annually. FDA estimates that approximately 40 firms subject to Sec. 201.105(d) disseminate 2,000 consumer-directed print promotional labeling pieces annually. FDA estimates that it will take firms approximately 10 hours to compile and draft the information needed to provide the information recommended in the revised draft guidance. Please note that the requirements related to print advertising pieces and the associated burden is already accounted for under the requirements under 21 CFR 202.1 and its approved information collection OMB control number 0910-0686 and, therefore, is not included in the burden estimate reported in table 1. Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Adequate information for use: Disclosing risk information in Number of Number of Total annual Hours per consumer-directed promotional respondents disclosures disclosures disclosure Total hours labeling per respondent ---------------------------------------------------------------------------------------------------------------- Disclosures Related to Adequate 400 60 24,000 10 240,000 Information for Use (Sec. 201.100(d)).................... Disclosures Related to Adequate 40 50 2,000 10 20,000 Information for Use (Sec. 201.105(d)).................... ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. This reissued revised draft guidance also refers to previously approved collections of information found in FDA regulations with respect to the brief summary requirement for print advertisements. These collections of information are subject to review by OMB under the PRA. The collection of information in Sec. 202.1 has been approved under OMB control number 0910-0686. III. Comments In addition to general comments, FDA specifically requests comments on the following issues:In the revised draft guidance, FDA provides recommendations regarding the content and format of the consumer brief summary. Is this the most useful information for consumers to use in determining whether to take a medication or seek more information about a product, and if not, what information would be more useful? FDA is also interested in relevant research that has been conducted or alternative formats that were developed after we received comments on the 2004 draft guidance. In the revised draft guidance, FDA suggests that the adequate directions for use requirement be fulfilled by providing the consumer brief summary rather than the full PI for the product. FDA seeks comments regarding this recommendation. Persons who commented on the version of the revised draft guidance issued in February 2015 do not need to resubmit their comments. When finalizing the revised draft guidance, we will review comments received on this reissued version, as well as the version issued February 2015. Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It [[Page 46993]] is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov. Dated: July 31, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19244 Filed 8-5-15; 8:45 am] BILLING CODE 4164-01-P
![46990 Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Notices
mailed to consumers) × $16.56 per comments before placing them on the the Commission by courier or overnight
hour.8] Commission Web site. service.
As elaborated on above, staff Because your comment will be made The FTC Act and other laws that the
estimates that a total of 14,560 labor public, you are solely responsible for Commission administers permit the
hours will be needed to negotiate or making sure that your comment does collection of public comments to
renegotiate outsourced service contracts not include any sensitive personal consider and use in this proceeding as
annually (or as conditions otherwise information, like anyone’s Social appropriate. The Commission will
change) to increase internet (8,320 Security number, date of birth, driver’s consider all timely and responsive
hours) and telephone (6,240 hours) license number or other state public comments that it receives on or
capacity requirements for internet web identification number or foreign country before October 5, 2015. For information
services and the automated telephone equivalent, passport number, financial on the Commission’s privacy policy,
call center. This will result in account number, or credit or debit card including routine uses permitted by the
approximately $953,971 per year in number. You are also solely responsible Privacy Act, see http://www.ftc.gov/ftc/
labor costs. [14,560 hours × $65.52 per for making sure that your comment does privacy.htm.
hour 9] not include any sensitive health
information, like medical records or David C. Shonka,
Thus, estimated cumulative labor will Principal Deputy General Counsel.
costs are $7,276,430. other individually identifiable health
information. In addition, do not include [FR Doc. 2015–19378 Filed 8–5–15; 8:45 am]
G. Capital/Non-Labor Costs any ‘‘[t]rade secret or any commercial or BILLING CODE 6750–01–P
As in the previous PRA clearance financial information which is . . .
analysis, FTC staff believes it is likely privileged or confidential’’ as provided
that consumer reporting agencies will in section 6(f) of the FTC Act 15 U.S.C. DEPARTMENT OF HEALTH AND
use third-party contractors (instead of 46(f), and FTC Rule 4.10(a)(2), 16 CFR HUMAN SERVICES
their own employees) to increase the 4.10(a)(2). In particular, do not include
competitively sensitive information Food and Drug Administration
capacity of their systems. Because of the
way these contracts are typically such as costs, sales statistics, [Docket No. FDA–2004–D–0500] (formerly
established, these costs will likely be inventories, formulas, patterns devices, Docket No. 2004D–0042)
incurred on a continuing basis, and will manufacturing processes, or customer
be calculated based on the number of names. Brief Summary and Adequate
If you want the Commission to give Directions for Use: Disclosing Risk
requests handled by the systems. Staff
your comment confidential treatment, Information in Consumer-Directed
estimates that the total annual amount
you must file it in paper form, with a Print Advertisements and Promotional
to be paid for services delivered under
request for confidential treatment, and Labeling for Prescription Drugs;
these contracts is $11,931,500.10
you have to follow the procedure Revised Draft Guidance for Industry
H. Net Burden for FTC, After 50:50 Split explained in FTC Rule 4.9(c).11 Your (Revision 2); Availability
comment will be kept confidential only
After halving the updated estimates to AGENCY: Food and Drug Administration,
if the FTC General Counsel grants your
split the PRA burden with the CFPB HHS.
request in accordance with the law and
regarding the Rule, the FTC’s burden ACTION: Notice of availability.
the public interest.
totals are 198,176 hours, $3,638,215 in Postal mail addressed to the
associated labor costs, and $5,965,750 in SUMMARY: The Food and Drug
Commission is subject to delay due to
non-labor/capital costs. Administration (FDA) is announcing the
heightened security screening. As a
reissuance of a revised draft guidance
III. Request for Comment result, we encourage you to submit your
for industry (Revision 2) entitled ‘‘Brief
comments online. To make sure that the
You can file a comment online or on Summary and Adequate Directions for
Commission considers your online
paper. For the Commission to consider Use: Disclosing Risk Information in
comment, you must file it at https://
your comment, we must receive it on or Consumer-Directed Print
ftcpublic.commentworks.com/ftc/
before October 5, 2015. Write ‘‘Subpart Advertisements and Promotional
regulationVsubpartNpra, by following
N of Regulation V, PRA Comment, Labeling for Prescription Drugs.’’ We are
the instructions on the web-based form.
P125403’’ on your comment. Your reissuing the revised draft guidance to
If this Notice appears at http://
comment—including your name and incorporate animal prescription drugs.
www.regulations.gov/#!home, you also
your state—will be placed on the public This reissued revised draft guidance,
may file a comment through that Web
record of this proceeding, including to when finalized, will assist
site.
the extent practicable, on the public If you file your comment on paper, manufacturers, packers, and distributors
Commission Web site, at http:// write ‘‘Subpart N of Regulation V, PRA (firms) of human prescription drugs,
www.ftc.gov/os/publiccomments.shtm. Comment, P125403’’ on your comment including biologics, and animal
As a matter of discretion, the and on the envelope, and mail or deliver prescription drugs, with meeting the
Commission tries to remove individuals’ it to the following address: Federal brief summary requirement for
home contact information from Trade Commission, Office of the prescription drug advertising and the
Secretary, Constitution Center, 400 7th requirement that adequate directions for
8 See Occupational Employment and Wages—
Street, SW. 5th Floor, Suite 5610 use be included with promotional
May 2014, Table 1, available at http://www.bls.gov/
(Annex J), Washington, DC 20024. If labeling for prescription drugs when
news.release/ocwage.nr0.htm (Office and print materials are directed toward
tkelley on DSK3SPTVN1PROD with NOTICES
administrative support workers, general). possible, submit your paper comment to
9 See supra notes 4 and 5.
consumers.
10 This consists of an estimated $7,913,500 for 11 In particular, the written request for DATES: Although you can comment on
automated telephone cost ($1.33 per request × 5.95 confidential treatment that accompanies the any guidance at any time (see 21 CFR
million requests) and an estimated $4,018,000 comment must include the factual and legal basis
($0.14 per request × 28.7 million requests) for for the request, and must identify the specific
10.115(g)(5)), to ensure that the Agency
Internet web service cost. Per unit cost estimates are portions of the comment to be withheld from the considers your comments on this
based on staff’s knowledge of the industry. public record. See FTC Rule 4.9(c), 16 CFR 4.9(c). reissued revised draft guidance before it
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![Federal Register / Vol. 80, No. 151 / Thursday, August 6, 2015 / Notices 46993
is only necessary to send one set of public health programs, MCHB, and pediatric clinicians’ participation and
comments. Identify comments with the HRSA; and ( ) support activities of the public-private partnership, such as the
docket number found in brackets in the Healthy Tomorrows Partnership for Early Childhood Comprehensive
heading of this document. Received Children Program (HTPCP) grantees to Systems Initiative, Project Launch, and
comments may be seen in the Division improve children’s health through private sector support for improved
of Dockets Management between 9 a.m. innovative community-based efforts, collaboration and coordination of and
and 4 p.m., Monday through Friday, and and community and statewide access to mental, oral, and physical
will be posted to the docket at http:// partnerships among professionals in health and non-clinical resources (e.g.
www.regulations.gov. health, education, social services, home visiting, early care and education
government, and business. The purpose settings such as child care and Head
IV. Electronic Access
of this notice is to award supplemental Start, early intervention, child welfare,
Persons with access to the Internet funds to develop the Rural IMPACT education) at the community level for
may obtain the document at http:// project to support activities related to children, youth, and their families.
www.fda.gov/Drugs/Guidance child health in rural and underserved In 2013, following objective review of
ComplianceRegulatoryInformation/ communities by the American Academy its application, HRSA awarded to the
Guidances/default.htm, http:// of Pediatrics, the cooperative agreement American Academy of Pediatrics (AAP)
www.fda.gov/BiologicsBloodVaccines/ awardee who serves as the NCMHI, cooperative agreement funding for the
GuidanceComplianceRegulatory during the budget period of July 1, 2015, NCMHI. If approved, this would be the
Information/default.htm, http:// to June 30, 2016. The NCMHI is first project expansion supplement for
www.fda.gov/AnimalVeterinary/ authorized by the Social Security Act, this project.
GuidanceComplianceEnforcement/ Title V, Sections 501(a)(1)(D) and Through the NCMHI, the AAP is
GuidanceforIndustry/default.htm, or 501(a)(2)), (42 U.S.C. 701). working to link key state and
http://www.regulations.gov. The NCHMI is a national resource to community programs, such as Title V,
Dated: July 31, 2015. implement and spread the medical school-based health centers, Head Start,
Leslie Kux, home model to all children and youth, and Early Intervention, which are
Associate Commissioner for Policy. particularly children with special health critical, natural access points for
[FR Doc. 2015–19244 Filed 8–5–15; 8:45 am]
care needs and children who are building and strengthening integrated
vulnerable and/or medically service delivery systems for women,
BILLING CODE 4164–01–P
underserved. The NCMHI supports children, and their families. Working
activities of the Health Tomorrows with the Healthy Tomorrows
DEPARTMENT OF HEALTH AND Partnership for Children Program Partnership for Children Program
HUMAN SERVICES grantees to improve children’s health grantees and the AAP Council on
through innovative community-based Community Pediatrics Rural Health
Health Resources and Services efforts, and community and statewide Special Interest Group, the NCMHI
Administration partnerships among professionals in supports activities that promote access
health, education, social services, to quality, patient/family-centered and
Program Expansion for the National government, and business. culturally effective services for children,
Center for Medical Home SUPPLEMENTARY INFORMATION: youth and their families, particularly in
Implementation Cooperative Intended Recipient of the Award: The rural and underserved communities.
Agreement at the American Academy American Academy of Pediatrics. The proposed Rural IMPACT Project
of Pediatrics Amount of the Non-Competitive activities align with the current project
AGENCY: Health Resources and Services Award: $300,000. plan, as the NCMHI advances system
Administration (HRSA), Department of CFDA Number: 93.110. changes and new initiatives at the
Health and Human Services (HHS). Current Project Period: July 01, 2008– community, state, and national levels,
June 30, 2018. building on community partnerships to
ACTION: Notice of Single-Case Deviation
Period of Supplemental Funding: July support family-centered medical home
from Competition Requirement for implementation for all children and
Program Expansion for the National 1, 2015–June 30, 2016.
Authority: Social Security Act, Title youth, particularly those
Center for Medical Home underrepresented and from diverse
Implementation Cooperative Agreement V, sections 501(a)(1)(D) and 501(a)(2),
(42 U.S.C. 701). communities (Goal 3). The AAP,
at the American Academy of Pediatrics, working with MCHB, would establish
Grant Number U43MC09134. Justification: The White House Rural
Council is leading a Rural Child Poverty an expert workgroup and operational
SUMMARY: HRSA announces its intent to Initiative, the Rural IMPACT Project, to structure to guide the initiative; develop
award a program expansion supplement support improved well-being and and issue a solicitation and scoring
in the amount of $300,000 for the upward economic mobility of children process and conduct a review of
National Center for Medical Home in rural and tribal communities. In applications to make recommendations
Implementation (NCMHI) cooperative collaboration with the White House for participating communities; develop
agreement. The purpose of the NCMHI Rural Council, HRSA, and the a quality improvement package; identify
cooperative agreement, as stated in the Administration for Children and systems-level measures to monitor
funding opportunity announcement, is Families, each using its own authority, process and progress of individual
to: (1) Support a national resource and used fiscal year (FY) 2015 funds to communities and the initiative as a
whole, and provide structured technical
tkelley on DSK3SPTVN1PROD with NOTICES
technical assistance effort to implement support a cohort of 10 rural and Tribal
and spread the medical home model to communities to provide two-generation, assistance to the selected communities.
all children and youth, particularly bundled services to children and FOR FURTHER INFORMATION CONTACT:
children with special health care needs families in need. Utilizing the two- Marie Y. Mann, MD, MPH, FAAP,
(CSHCN), children who are vulnerable generation approach, the communities Division of Services for Children with
and/or medically underserved, and will promote problem solving at the Special Health Needs, Maternal and
pediatric populations served by state community level by encouraging Child Health Bureau, Health Resources
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Document Created: 2018-02-23 10:55:54
Document Modified: 2018-02-23 10:55:54
| 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 | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this reissued revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the reissued revised draft guidance by October 5, 2015. Submit either electronic or written comments on the proposed collection of information by October 5, 2015. | |
| Contact | Regarding human prescription drugs: Julie Chronis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-1200. Regarding human prescription biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding animal prescription drugs: Thomas Moskal, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. Rockville, MD 20855-2792, 240-402-6251. | |
| FR Citation | 80 FR 46990 |
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