Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations To Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood Components; Agency Guidance, 18983-18984 [2020-06986]

Download as PDF 18983 Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices necessary information to improve program processes and operations in order to improve the quality of STD prevention and treatment. The 4,500 respondents (who will engage in a total of 11,769 respondent instances) represent an average of the number of health professionals trained by PTC grantees during 2015. The evaluation instruments collect data on the impact of the training by the NNPTC. This data collection is necessary to assess and evaluate the performance of the grantees in delivering training, and to standardize training registration processes across the PTCs. The NNPTC Abbreviated HPAT allows CDC grantees to use a single instrument when collecting demographic data from its training and capacity building participants, regarding their: (1) Occupations, professions, and functional roles; (2) principal employment settings; (3) location of their work settings; and (4) programmatic and population foci of their work. The NNPTC Abbreviated HPAT takes approximately three minutes to complete. This data collection provides CDC with information to determine whether the training grantees are reaching their target audiences in terms of provider type, the types of organizations in which participants work, the focus of their work and the population groups and geographic areas served. The evaluation instruments are used to assess training and capacity-building outcomes (knowledge, confidence, intention to use information, actual changes made as a result of training) immediately after and again 90 days after training events. The evaluation instruments vary based on the type of training offered and take between approximately 16 minutes to complete (for intensive multi-day trainings) to two minutes to complete (for short didactic or webinar sessions). The CDC’s Funding Opportunity Announcement PS 14–1407, National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC) requires the collection of national demographic information on grantees’ trainees and national evaluation outcomes. There are no costs to respondents other than their time. The estimated annualized burden hours for this data collection are 502 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Healthcare Professionals ........ NNPTC Abbreviated Health Professional Application for Training (HPAT). Intensive Complete Post-Course Evaluation ......................... Intensive Complete Long-Term Evaluation ............................ Intensive-Didactic Post-Course Evaluation ............................ Intensive-Didactic Long-Term Evaluation .............................. Practicum Post-Course Evaluation ........................................ Practicum Long-Term Evaluation ........................................... Wet Mount Post-Course Evaluation ....................................... Wet Mount Long-Term Evaluation ......................................... STD Tx Guidelines Complete Post-Course Evaluation ......... STD Tx Guidelines Complete Long-Term Evaluation ............ Short Guidelines Post-Course Evaluation .............................. Short Guidelines Long-Term Evaluation ................................ Basic Post-Course Evaluation ................................................ Basic Long-Term Evaluation .................................................. Immediate Post-Course email invitation ................................ 3 Month Long-Term email invitation ...................................... Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Healthcare Professionals ........ Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–06943 Filed 4–2–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–5971] jbell on DSKJLSW7X2PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: 17:45 Apr 02, 2020 Average burden per response (in hours) 4,500 1 3/60 116 36 166 58 70 20 40 15 548 180 500 160 150 50 4,500 660 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 16/60 10/60 10/60 7/60 4/60 3/60 3/60 2/60 6/60 5/60 3/60 3/60 2/60 2/60 1/60 1/60 information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). Submit written comments (including recommendations) on the collection of information by May 4, 2020. DATES: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations To Reduce the Risk of TransfusionTransmitted of Infection in Whole Blood and Blood Components; Agency Guidance VerDate Sep<11>2014 Number responses per respondent Jkt 250001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0681. Also include the FDA docket number found in ADDRESSES: E:\FR\FM\03APN1.SGM 03APN1 18984 Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Recommendations To Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance jbell on DSKJLSW7X2PROD with NOTICES OMB Control Number 0910–0681— Extension Under § 630.3(h) (21 CFR 630.3(h)), a list is set forth of relevant transfusiontransmitted infections (RTTIs) (§ 630.3(h)(1)) and the conditions under which a transfusion-transmitted infection (TTI) would meet the definition of an RTTI (§ 630.3(h)(2)). The list of RTTIs under § 630.3(h)(1) includes, among other things, the following: Trypanosoma cruzi (Chagas), Creutzfeldt Jacob Disease (CJD)/variant Creutzfeldt Jacob Disease (vCJD), plasmodium species (malaria), and West Nile virus. The RTTIs FDA has identified thus far under § 630.3(h)(2) include Zika virus and babesiosis. In addition, FDA has determined Ebola virus to be a TTI identified under § 630.3(l). FDA has issued several guidance documents with recommendations regarding the RTTIs or TTIs including Chagas, babesiosis, Zika virus, West Nile virus, Ebola virus, malaria, CJD and vCJD, human immunodeficiency virus (HIV) and human T-lymphotropic virus, types I and II (HTLV). The Chagas, babesiosis, Zika virus, West Nile virus, and HTLV guidance documents provide recommendations for consignee and physician notification relating to donors that tested reactive for these infections. In addition, a blood establishment may receive information from a donor following collection that reveals the donor had a risk factor for an RTTI or TTI at the time of collection and should have been deferred for the risk factor. FDA has recommended, in the following guidance documents, that such a blood collection establishment notify the consignee regarding the distributed blood components that are potentially at-risk for an RTTI or TTI. In some cases, we recommend that if the blood VerDate Sep<11>2014 17:45 Apr 02, 2020 Jkt 250001 was transfused, the consignee notify the transfusion recipient’s physician of record regarding the potential risk. This recommendation is included in Ebola virus, malaria, CJD and vCJD, and HIV guidance documents. These guidance documents are available from our website at https://www.fda.gov/ vaccines-blood-biologics/biologicsguidances/blood-guidances. In the Federal Register of January 7, 2020 (85 FR 716), we published a 60day notice requesting public comment on the proposed collection of information. For purposes of estimating burden under the PRA, we provided an estimate of one response and one burden hour annually. As we discussed in our 60-day notice, although such notifications are rare, we believe that these notification practices would be part of the usual and customary business practice for blood establishments and consignees in addressing the RTTIs or TTIs under the regulations. In addition, we believe respondents would have already developed standard operating procedures for notifying consignees and the recipient’s physician of record regarding distributed blood components potentially at risk for a TTI. No comments were received in response to our 60-day notice, and we therefore retain this estimate. As other relevant transfusion-transmitted infections are determined under § 630.3, we may continue to issue guidance accordingly, and, if approved, intend the information collections to be included under this OMB control number. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. These guidance documents, as applicable, also refer to previously approved FDA collections of information. The collections of information in 21 CFR parts 601 and 640, and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR parts 606 and 630 have been approved under OMB control number 0910–0116; the collections of information in 21 CFR 606.171 have been approved under OMB control number 0910–0458. Dated: March 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06986 Filed 4–2–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2066] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) 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. DATES: Submit written comments (including recommendations) on the collection of information by May 4, 2020. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0832. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Certification of Identity; Form FDA 3975 OMB Control Number 0910–0832— Extension This information collection supports Form FDA 3975 entitled ‘‘Certification of Identity,’’ which is used by FDA to identify an individual requesting a particular record under the Freedom of Information Act (FOIA) and the Privacy Act. The form is available from our website at: https://www.fda.gov/ E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18983-18984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06986]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5971]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommendations To 
Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood 
and Blood Components; Agency Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0681. Also include the FDA docket 
number found in

[[Page 18984]]

brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Recommendations To Reduce the Risk of Transfusion-Transmitted Infection 
in Whole Blood and Blood Components; Agency Guidance

OMB Control Number 0910-0681--Extension

    Under Sec.  630.3(h) (21 CFR 630.3(h)), a list is set forth of 
relevant transfusion-transmitted infections (RTTIs) (Sec.  630.3(h)(1)) 
and the conditions under which a transfusion-transmitted infection 
(TTI) would meet the definition of an RTTI (Sec.  630.3(h)(2)). The 
list of RTTIs under Sec.  630.3(h)(1) includes, among other things, the 
following: Trypanosoma cruzi (Chagas), Creutzfeldt Jacob Disease (CJD)/
variant Creutzfeldt Jacob Disease (vCJD), plasmodium species (malaria), 
and West Nile virus. The RTTIs FDA has identified thus far under Sec.  
630.3(h)(2) include Zika virus and babesiosis. In addition, FDA has 
determined Ebola virus to be a TTI identified under Sec.  630.3(l). FDA 
has issued several guidance documents with recommendations regarding 
the RTTIs or TTIs including Chagas, babesiosis, Zika virus, West Nile 
virus, Ebola virus, malaria, CJD and vCJD, human immunodeficiency virus 
(HIV) and human T-lymphotropic virus, types I and II (HTLV).
    The Chagas, babesiosis, Zika virus, West Nile virus, and HTLV 
guidance documents provide recommendations for consignee and physician 
notification relating to donors that tested reactive for these 
infections.
    In addition, a blood establishment may receive information from a 
donor following collection that reveals the donor had a risk factor for 
an RTTI or TTI at the time of collection and should have been deferred 
for the risk factor. FDA has recommended, in the following guidance 
documents, that such a blood collection establishment notify the 
consignee regarding the distributed blood components that are 
potentially at-risk for an RTTI or TTI. In some cases, we recommend 
that if the blood was transfused, the consignee notify the transfusion 
recipient's physician of record regarding the potential risk. This 
recommendation is included in Ebola virus, malaria, CJD and vCJD, and 
HIV guidance documents. These guidance documents are available from our 
website at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.
    In the Federal Register of January 7, 2020 (85 FR 716), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. For purposes of estimating burden under the 
PRA, we provided an estimate of one response and one burden hour 
annually. As we discussed in our 60-day notice, although such 
notifications are rare, we believe that these notification practices 
would be part of the usual and customary business practice for blood 
establishments and consignees in addressing the RTTIs or TTIs under the 
regulations. In addition, we believe respondents would have already 
developed standard operating procedures for notifying consignees and 
the recipient's physician of record regarding distributed blood 
components potentially at risk for a TTI. No comments were received in 
response to our 60-day notice, and we therefore retain this estimate. 
As other relevant transfusion-transmitted infections are determined 
under Sec.  630.3, we may continue to issue guidance accordingly, and, 
if approved, intend the information collections to be included under 
this OMB control number.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. These guidance documents, as applicable, also refer to 
previously approved FDA collections of information. The collections of 
information in 21 CFR parts 601 and 640, and Form FDA 356h have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR parts 606 and 630 have been approved under OMB 
control number 0910-0116; the collections of information in 21 CFR 
606.171 have been approved under OMB control number 0910-0458.

    Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06986 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P

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