81_FR_73012 81 FR 72808 - 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

81 FR 72808 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 204 (October 21, 2016)

Page Range72808-72809
FR Document2016-25481

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).

Federal Register, Volume 81 Issue 204 (Friday, October 21, 2016) 
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72808-72809]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected]. 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, [email protected].

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

72808 Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices State Grantee Amount New Hampshire ........................................ NH. Dept. of Health & Human Services ...................................................................... 25,736 New Jersey ............................................... New Jersey Department of Human Services .............................................................. 25,736 New Mexico .............................................. New Mexico Human Services Department .................................................................. 25,736 New York .................................................. NY Office of Temporary and Disability Assistance ...................................................... 171,426 North Carolina ........................................... North Caroline Dept. of Health & Human Services ..................................................... 84,000 North Dakota ............................................. North Dakota Department of Public Instruction ........................................................... 25,736 Ohio .......................................................... Ohio Department of Job and Family Services ............................................................. 73,746 Oregon ...................................................... Lutheran Community Services Northwest ................................................................... 39,822 Pennsylvania ............................................. Commonwealth of Pennsylvania .................................................................................. 100,488 Rhode Island ............................................. Rhode Island Department of Human Services ............................................................ 25,736 South Dakota ............................................ Lutheran Social Services of South Dakota .................................................................. 25,736 Tennessee ................................................ Catholic Charities of Tennessee, Inc. .......................................................................... 56,671 Texas ........................................................ Texas Health and Human Services Commission ........................................................ 171,426 Utah .......................................................... Utah Department of Workforce Services ..................................................................... 43,797 Vermont .................................................... Vermont Agency of Human Services ........................................................................... 25,736 Virginia ...................................................... Virginia Department of Social Services ....................................................................... 66,428 Washington ............................................... WA State Department of Social & Health Services ..................................................... 107,083 Wisconsin .................................................. Wisconsin Department of Public Instruction ................................................................ 31,240 Total ................................................... ....................................................................................................................................... 2,500,000 ORR provides 28 States and ten DEPARTMENT OF HEALTH AND and Drug Administration, Three White Wilson-Fish agencies with Refugee HUMAN SERVICES Flint North, 10A63, 11601 Landsdown School Impact funding to undertake a St., North Bethesda, MD 20852, comprehensive statewide approach Food and Drug Administration PRAStaff@fda.hhs.gov. supporting local school systems that are [Docket No. FDA–2010–D–0319] SUPPLEMENTARY INFORMATION: In impacted by significant numbers of compliance with 44 U.S.C. 3507, FDA newly arrived refugee children. As Agency Information Collection has submitted the following proposed currently awarded, the FY14–16 Activities; Submission for Office of collection of information to OMB for Refugee School Impact funding period Management and Budget Review; review and clearance. concludes on August 14, 2016. Comment Request; Guidance for Beginning in FFY17, ORR will award Industry and Food and Drug Guidance for Industry and Food and Refugee School Impact funding as a Administration Staff on Dear Health Drug Administration Staff on Dear formula set-aside within the Refugee Care Provider Letters: Improving Health Care Provider Letters: Social Services funding awarded to all Communication of Important Safety Improving Communication of States and Wilson-Fish programs Information Important Safety Information—OMB coordinating refugee resettlement. This Control Number 0910–0754—Extension change in timing for Refugee School AGENCY: Food and Drug Administration, Impact funding will create a gap in HHS. This final Guidance for Industry and Refugee School Impact program services ACTION: Notice. FDA staff entitled ‘‘Dear Health Care between August 15, 2016 and October 1, Provider Letters: Improving SUMMARY: The Food and Drug Communication of Important Safety 2016. The low-cost extensions will Administration (FDA or we) is support refugee access to services Information’’ offers specific guidance to announcing that a proposed collection industry and FDA staff on the content critical to refugee student success at the of information has been submitted to the beginning of the school year, when such and format of Dear Health Care Provider Office of Management and Budget (DHCP) letters. These letters are sent by services are greatest and most urgent. (OMB) for review and clearance under manufacturers or distributors to health DATES: Low-cost extension supplement the Paperwork Reduction Act of 1995 care providers to communicate an grants will support activities from (the PRA). important drug warning, a change in August 15, 2016, through September 30, DATES: Fax written comments on the prescribing information, or a correction 2016. collection of information by November of misinformation in prescription drug FOR FURTHER INFORMATION CONTACT: Carl 21, 2016. promotional labeling or advertising. Rubenstein, Director, Division of ADDRESSES: To ensure that comments on Refugee Assistance, Office of Refugee This guidance gives specific the information collection are received, instruction on what should and should Resettlement, 330 C Street SW., OMB recommends that written Washington, DC 20201. Email: not be included in DHCP letters. To comments be faxed to the Office of date, some DHCP letters have been too carl.rubenstein@acf.hhs.gov. Information and Regulatory Affairs, long, have contained promotional Statutory Authority: This program is OMB, Attn: FDA Desk Officer, FAX: material, or otherwise have not met the authorized by Section 412(c)(1)(A)(iii) of the 202–395–7285, or emailed to oira_ goals set forth in the applicable asabaliauskas on DSK3SPTVN1PROD with NOTICES Immigration and Nationality Act (INA), 8 submission@omb.eop.gov. All U.S.C. 1522(c)(1)(A)(iii). regulation (21 CFR 200.5). In some comments should be identified with the cases, health care providers have not Christopher Beach, OMB control number 0910–0754. Also been aware of important new Senior Grants Policy Specialist, Office of include the FDA docket number found information and have been unable to Administration, Office of Financial Services, in brackets in the heading of this communicate it to patients because the Division of Grants Policy. document. letters’ content and length have made it [FR Doc. 2016–25496 Filed 10–20–16; 8:45 am] FOR FURTHER INFORMATION CONTACT: FDA difficult to find the relevant BILLING CODE 4184–01–P PRA Staff, Office of Operations, Food information. In addition, letters have VerDate Sep<11>2014 19:06 Oct 20, 2016 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1

Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices 72809 sometimes been sent for the wrong identified DHCP letters that were sent hours to prepare and send DHCP letters reasons. and the identity of each sponsor sending in accordance with the guidance. In addition to content and format out a DHCP letter for each year. We In the Federal Register of March 10, recommendations for each type of DHCP estimate that we will receive 2016 (81 FR 12734), we published a 60- letter, the guidance also includes advice approximately 25 DHCP Letters day notice requesting public comment on consulting with FDA to develop a annually from approximately 18 on the proposed extension of this DHCP letter, when to send a letter, what application holders. FDA professionals collection of information. No comments type of letter to send, and conducting an familiar with DHCP letters and with the assessment of the letter’s impact. were received. recommendations in the guidance FDA estimates the annual reporting Based on a review of FDA’s Document Archiving, Reporting and Regulatory estimate that it should take an burden of this collection of information Tracking System for 2012 to 2015, we application holder approximately 100 as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of re- Average bur- Number of re- Total annual Activity sponses per den per re- Total hours spondents responses respondent sponse (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. Advisory Committee Membership recommendations on ways of Leslie Kux, Nomination Portal: https:// communicating to the public the Associate Commissioner for Policy. www.accessdata.fda.gov/scripts/ potential risks associated with these [FR Doc. 2016–25481 Filed 10–20–16; 8:45 am] FACTRSPortal/FACTRS/index.cfm or by issues and on approaches that might be BILLING CODE 4164–01–P mail to Advisory Committee Oversight considered for addressing the issues. and Management Staff, Food and Drug II. Criteria for Voting Members Administration, 10903 New Hampshire DEPARTMENT OF HEALTH AND Ave., Bldg. 32, Rm. 5103, Silver Spring, The Committee consists of a core of HUMAN SERVICES MD 20993–0002. 15 voting members including the Chair. FOR FURTHER INFORMATION CONTACT: Members and the Chair are selected by Food and Drug Administration Regarding all nomination questions for the Commissioner of Food and Drugs [Docket No. FDA–2016–N–0001] membership, the primary contact is: (the Commissioner) designee from Karen Strambler, 5001 Campus Drive, among authorities knowledgeable in the Request for Nominations for Voting Rm. 1C–008, College Park, MD 20740, fields of physical sciences, biological Members on a Public Advisory email: karen.strambler@fda.hhs.gov, and life sciences, food science, risk Committee; Food Advisory Committee 240–402–2589, Fax: 301–436–2367. assessment, nutrition, food technology, Information about becoming a molecular biology, epidemiology and AGENCY: Food and Drug Administration, member on an FDA advisory committee other relevant scientific and technical HHS. can also be obtained by visiting FDA’s disciplines. Members will be invited to ACTION: Notice. Web site by using the following link: serve for overlapping terms of up to 4 http://www.fda.gov/ years. Almost all non-Federal members SUMMARY: The Food and Drug AdvisoryCommittees/default.htm. of this Committee serve as Special Administration (FDA) is requesting Government Employees. The core of SUPPLEMENTARY INFORMATION: FDA is nominations for voting members to voting members may include two requesting nomination for voting serve on the Food Advisory Committee technically qualified member(s), members on the Committee. (the Committee), Office of Regulations, selected by the Commissioner or Policy, and Social Sciences, Center for I. General Description of the Committee designee, who are identified with Food Safety and Applied Nutrition. Duties consumer interests and are FDA seeks to include the views of The Committee reviews and evaluates recommended by either a consortium of women and men, members of all racial emerging food safety, nutrition, and consumer-oriented organizations or and ethnic groups, and individuals with other food- or cosmetic-related health other interested persons. In addition to and without disabilities on its advisory issues that FDA considers of primary the voting members, the Committee may committees and, therefore, encourages importance for its food and cosmetics include two non-voting member(s) who nominations of appropriately qualified programs. The Committee may be are identified with industry interests. candidates from these groups. charged with reviewing and evaluating DATES: Nominations received on or III. Nomination Procedures available data and making before December 20, 2016, will be given recommendations on matters such as Any interested person may nominate first consideration for membership on those relating to: (1) Broad scientific and one or more qualified individuals for asabaliauskas on DSK3SPTVN1PROD with NOTICES the Food Advisory Committee. technical food- or cosmetic-related membership on the advisory committee. Nominations received after December issues, (2) the safety of food ingredients Self-nominations are also accepted. 20, 2016, will be considered for and new foods, (3) labeling of foods and Nominations must include a current, nomination to the committee as later cosmetics, (4) nutrient needs and complete résumé or curriculum vitae for vacancies occur. nutritional adequacy, and (5) safe each nominee, including current ADDRESSES: All nominations for exposure limits for food contaminants. business address and/or home address, membership should be sent The Committee may also be asked to telephone number, and email address if electronically by logging into the FDA provide advice and make available. Nominations must also VerDate Sep<11>2014 19:06 Oct 20, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1


Document Created: 2018-02-13 16:36:03
Document Modified: 2018-02-13 16:36:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by November 21, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 72808 
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