Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 72808-72809 [2016-25481]

Download as PDF 72808 Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices State Grantee New Hampshire ........................................ New Jersey ............................................... New Mexico .............................................. New York .................................................. North Carolina ........................................... North Dakota ............................................. Ohio .......................................................... Oregon ...................................................... Pennsylvania ............................................. Rhode Island ............................................. South Dakota ............................................ Tennessee ................................................ Texas ........................................................ Utah .......................................................... Vermont .................................................... Virginia ...................................................... Washington ............................................... Wisconsin .................................................. NH. Dept. of Health & Human Services ...................................................................... New Jersey Department of Human Services .............................................................. New Mexico Human Services Department .................................................................. NY Office of Temporary and Disability Assistance ...................................................... North Caroline Dept. of Health & Human Services ..................................................... North Dakota Department of Public Instruction ........................................................... Ohio Department of Job and Family Services ............................................................. Lutheran Community Services Northwest ................................................................... Commonwealth of Pennsylvania .................................................................................. Rhode Island Department of Human Services ............................................................ Lutheran Social Services of South Dakota .................................................................. Catholic Charities of Tennessee, Inc. .......................................................................... Texas Health and Human Services Commission ........................................................ Utah Department of Workforce Services ..................................................................... Vermont Agency of Human Services ........................................................................... Virginia Department of Social Services ....................................................................... WA State Department of Social & Health Services ..................................................... Wisconsin Department of Public Instruction ................................................................ 25,736 25,736 25,736 171,426 84,000 25,736 73,746 39,822 100,488 25,736 25,736 56,671 171,426 43,797 25,736 66,428 107,083 31,240 Total ................................................... ....................................................................................................................................... 2,500,000 asabaliauskas on DSK3SPTVN1PROD with NOTICES ORR provides 28 States and ten Wilson-Fish agencies with Refugee School Impact funding to undertake a comprehensive statewide approach supporting local school systems that are impacted by significant numbers of newly arrived refugee children. As currently awarded, the FY14–16 Refugee School Impact funding period concludes on August 14, 2016. Beginning in FFY17, ORR will award Refugee School Impact funding as a formula set-aside within the Refugee Social Services funding awarded to all States and Wilson-Fish programs coordinating refugee resettlement. This change in timing for Refugee School Impact funding will create a gap in Refugee School Impact program services between August 15, 2016 and October 1, 2016. The low-cost extensions will support refugee access to services critical to refugee student success at the beginning of the school year, when such services are greatest and most urgent. DATES: Low-cost extension supplement grants will support activities from August 15, 2016, through September 30, 2016. FOR FURTHER INFORMATION CONTACT: Carl Rubenstein, Director, Division of Refugee Assistance, Office of Refugee Resettlement, 330 C Street SW., Washington, DC 20201. Email: carl.rubenstein@acf.hhs.gov. Statutory Authority: This program is authorized by Section 412(c)(1)(A)(iii) of the Immigration and Nationality Act (INA), 8 U.S.C. 1522(c)(1)(A)(iii). Christopher Beach, Senior Grants Policy Specialist, Office of Administration, Office of Financial Services, Division of Grants Policy. [FR Doc. 2016–25496 Filed 10–20–16; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 19:06 Oct 20, 2016 Jkt 241001 Amount Food and Drug Administration and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. [Docket No. FDA–2010–D–0319] SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by November 21, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0754. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information—OMB Control Number 0910–0754—Extension This final Guidance for Industry and FDA staff entitled ‘‘Dear Health Care Provider Letters: Improving Communication of Important Safety Information’’ offers specific guidance to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance gives specific instruction on what should and should not be included in DHCP letters. To date, some DHCP letters have been too long, have contained promotional material, or otherwise have not met the goals set forth in the applicable regulation (21 CFR 200.5). In some cases, health care providers have not been aware of important new information and have been unable to communicate it to patients because the letters’ content and length have made it difficult to find the relevant information. In addition, letters have E:\FR\FM\21OCN1.SGM 21OCN1 72809 Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices sometimes been sent for the wrong reasons. In addition to content and format recommendations for each type of DHCP letter, the guidance also includes advice on consulting with FDA to develop a DHCP letter, when to send a letter, what type of letter to send, and conducting an assessment of the letter’s impact. Based on a review of FDA’s Document Archiving, Reporting and Regulatory Tracking System for 2012 to 2015, we identified DHCP letters that were sent and the identity of each sponsor sending out a DHCP letter for each year. We estimate that we will receive approximately 25 DHCP Letters annually from approximately 18 application holders. FDA professionals familiar with DHCP letters and with the recommendations in the guidance estimate that it should take an application holder approximately 100 hours to prepare and send DHCP letters in accordance with the guidance. In the Federal Register of March 10, 2016 (81 FR 12734), we published a 60day notice requesting public comment on the proposed extension of this collection of information. No comments were received. FDA estimates the annual reporting burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response (hours) Total hours Annual average .................................................................... 18 1.4 25 100 2,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 17, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25481 Filed 10–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (the Committee), Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before December 20, 2016, will be given first consideration for membership on the Food Advisory Committee. Nominations received after December 20, 2016, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:06 Oct 20, 2016 Jkt 241001 Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is: Karen Strambler, 5001 Campus Drive, Rm. 1C–008, College Park, MD 20740, email: karen.strambler@fda.hhs.gov, 240–402–2589, Fax: 301–436–2367. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site by using the following link: http://www.fda.gov/ AdvisoryCommittees/default.htm. SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting members on the Committee. I. General Description of the Committee Duties The Committee reviews and evaluates emerging food safety, nutrition, and other food- or cosmetic-related health issues that FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food- or cosmetic-related issues, (2) the safety of food ingredients and new foods, (3) labeling of foods and cosmetics, (4) nutrient needs and nutritional adequacy, and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. II. Criteria for Voting Members The Committee consists of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner of Food and Drugs (the Commissioner) designee from among authorities knowledgeable in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, epidemiology and other relevant scientific and technical disciplines. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this Committee serve as Special Government Employees. The core of voting members may include two technically qualified member(s), selected by the Commissioner or designee, who are identified with consumer interests and are recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include two non-voting member(s) who are identified with industry interests. III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, ´ ´ complete resume or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available. Nominations must also E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72808-72809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
and Food and Drug Administration Staff on Dear Health Care Provider 
Letters: Improving Communication of Important Safety Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
November 21, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0754. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry and Food and Drug Administration Staff on Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information--OMB Control Number 0910-0754--Extension

    This final Guidance for Industry and FDA staff entitled ``Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information'' offers specific guidance to industry and FDA staff 
on the content and format of Dear Health Care Provider (DHCP) letters. 
These letters are sent by manufacturers or distributors to health care 
providers to communicate an important drug warning, a change in 
prescribing information, or a correction of misinformation in 
prescription drug promotional labeling or advertising.
    This guidance gives specific instruction on what should and should 
not be included in DHCP letters. To date, some DHCP letters have been 
too long, have contained promotional material, or otherwise have not 
met the goals set forth in the applicable regulation (21 CFR 200.5). In 
some cases, health care providers have not been aware of important new 
information and have been unable to communicate it to patients because 
the letters' content and length have made it difficult to find the 
relevant information. In addition, letters have

[[Page 72809]]

sometimes been sent for the wrong reasons.
    In addition to content and format recommendations for each type of 
DHCP letter, the guidance also includes advice on consulting with FDA 
to develop a DHCP letter, when to send a letter, what type of letter to 
send, and conducting an assessment of the letter's impact.
    Based on a review of FDA's Document Archiving, Reporting and 
Regulatory Tracking System for 2012 to 2015, we identified DHCP letters 
that were sent and the identity of each sponsor sending out a DHCP 
letter for each year. We estimate that we will receive approximately 25 
DHCP Letters annually from approximately 18 application holders. FDA 
professionals familiar with DHCP letters and with the recommendations 
in the guidance estimate that it should take an application holder 
approximately 100 hours to prepare and send DHCP letters in accordance 
with the guidance.
    In the Federal Register of March 10, 2016 (81 FR 12734), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    FDA estimates the annual reporting burden of this collection of 
information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses         (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual average.....................................................              18              1.4               25              100            2,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25481 Filed 10-20-16; 8:45 am]
 BILLING CODE 4164-01-P