82 FR 61013 - Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 246 (December 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 246 (December 26, 2017)
| Page Range | 61013-61015 | |
| FR Document | 2017-27757 |
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)] [Notices] [Pages 61013-61015] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27757] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1069] Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830. DATES: Submit electronic or written comments on the collection of information by February 26, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-N-1069 for ``Blood Establishment Registration and Product Listing, Form FDA 2830.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under 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, including each proposed extension of an existing 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. 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 [[Page 61014]] 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 to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Blood Establishment Registration and Product Listing, Form FDA 2830--21 CFR part 607 (OMB Control Number 0910-0052--Extension) Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, places of business, and all such establishments, among other information, and must submit a list of all drug and all device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution, among other information. In 21 CFR part 607, FDA has issued regulations implementing these requirements for manufacturers of human blood and blood products. Section 607.20(a), requires, in part, that owners or operators of certain establishments that engage in the manufacture of blood products register and submit a list of every blood product in commercial distribution. Section 607.21 requires the owner or operator of an establishments entering into the manufacturing of blood products to register the establishment within 5 days after beginning such operation and to submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation for which a license is required, registration must follow within 5 days after the submission of a biologics license application. In addition, owners or operators of all establishments so engaged must register annually between October 1 and December 31 and update their blood product listing every June and December. Section 607.22(a) requires, in part, that initial and subsequent registrations and product listings be submitted electronically through the Blood Establishment Registration and Product Listing system or any future superseding electronic system. Section 607.22(b) requires, in part, that requests for a waiver of the requirements of Sec. 607.22 be submitted in writing and include the specific reasons why electronic submission is not reasonable for the registrant. Section 607.22(c) provides that if FDA grants the waiver request, FDA may limit its duration and will specify the terms of the waiver and provide information on how to submit establishment registration, drug listings, other information, and updates, as applicable (e.g., Form FDA 2830). Section 607.25 sets forth the information required for establishment registration and blood product listing. Section 607.26 requires, in part, that certain changes, such as ownership or location changes, be submitted to FDA electronically as an amendment to establishment registration within 5 calendar days of such changes using the FDA Blood Establishment Registration and Product Listing system, or any future superseding electronic system. Section 607.30(a), in part, sets forth the information required from owners or operators of establishments when they update their blood product listing information in June and December of each year (at a minimum). Section 607.31 requires that certain additional blood product listing information be provided upon request by FDA. Section 607.40 requires, in part, that certain foreign blood product establishments comply with the establishment registration and blood product listing information requirements in part 607, subpart B (Sec. Sec. 607.20 through 607.39, 607.40(a) and (b)), and provide the name and address of the establishment and the name of the individual responsible for submitting establishment registration and blood product listing information (Sec. 607.40(c)) as well as the name, address, and phone number of its U.S. agent (Sec. 607.40(d)). This information assists FDA in its inspections of facilities, among other uses, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the Nation's blood supply. Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. FDA estimates the burden of this collection of information based upon information obtained from the database of FDA's Center for Biologics Evaluation and Research and FDA experience with the blood establishment registration and product listing requirements. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Activity/Form FDA Number of responses per Total annual Average burden per response Total hours 2830 respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 607.20(a), 607.21, 607.22, Initial Registration 115 1 115 1.............................. 115 607.25, and 607.40. 607.21, 607.22, 607.25, 607.26, Annual Registration. 2,612 1 2,612 0.5 (30 minutes)............... 1,306 607.31, and 607.40. 607.21, 607.25, 607.30(a), Product Listing 200 1 200 0.25 (15 minutes).............. 50 607.31, and 607.40. Update. 607.22(b)........................ Waiver Requests..... 25 .............. 25 1.............................. 25 ------------------------------------------------------------------------------------------------ Total........................ .................... .............. .............. .............. ............................... 1,496 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs of operating and maintenance costs associated with this collection of information. [[Page 61015]] The burden for this information collection has changed since the last OMB approval. Because of a slight increase in the number of initial registrations and product listing updates FDA has received during the past 3 years, we have increased our reporting burden estimate. Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. 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![Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices 61013
Dated: December 20, 2017. Comments submitted electronically, claimed confidential information
Leslie Kux, including attachments, to https:// redacted/blacked out, will be available
Associate Commissioner for Policy. www.regulations.gov will be posted to for public viewing and posted on
[FR Doc. 2017–27786 Filed 12–22–17; 8:45 am] the docket unchanged. Because your https://www.regulations.gov. Submit
BILLING CODE 4164–01–P
comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
comment does not include any contact information to be made publicly
DEPARTMENT OF HEALTH AND confidential information that you or a available, you can provide this
HUMAN SERVICES third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
Food and Drug Administration anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
[Docket No. FDA–2014–N–1069]
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Agency Information Collection that if you include your name, contact except in accordance with 21 CFR 10.20
Activities; Proposed Collection; information, or other information that and other applicable disclosure law. For
Comment Request; Blood identifies you in the body of your more information about FDA’s posting
Establishment Registration and comments, that information will be of comments to public dockets, see 80
Product Listing, Form FDA 2830 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. do not wish to be made available to the 23389.pdf.
ACTION: Notice. public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). received, go to https://
announcing an opportunity for public www.regulations.gov and insert the
Written/Paper Submissions
comment on the proposed collection of docket number, found in brackets in the
certain information by the Agency. Submit written/paper submissions as heading of this document, into the
Under the Paperwork Reduction Act of follows: ‘‘Search’’ box and follow the prompts
1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
required to publish notice in the written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Federal Register concerning each Management Staff (HFA–305), Food and Rockville, MD 20852.
proposed collection of information, Drug Administration, 5630 Fishers
FOR FURTHER INFORMATION CONTACT: Ila
including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments S. Mizrachi, Office of Operations, Food
existing collection of information, and and Drug Administration, Three White
to allow 60 days for public comment in submitted to the Dockets Management
Staff, FDA will post your comment, as Flint North, 10A–12M, 11601
response to the notice. This notice Landsdown St., North Bethesda, MD
solicits comments on the information well as any attachments, except for
information submitted, marked and 20852, 301–796–7726, PRAStaff@
collection requirements relating to the fda.hhs.gov.
blood establishment registration and identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
product listing requirements in the
Agency’s regulations and Form FDA Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
2830. must include the Docket No. FDA– Agencies must obtain approval from the
2014–N–1069 for ‘‘Blood Establishment Office of Management and Budget
DATES: Submit electronic or written Registration and Product Listing, Form (OMB) for each collection of
comments on the collection of FDA 2830.’’ Received comments, those information they conduct or sponsor.
information by February 26, 2018. filed in a timely manner (see ‘‘Collection of information’’ is defined
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
as follows. Please note that late, and, except for those submitted as 1320.3(c) and includes Agency requests
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly or requirements that members of the
considered. Electronic comments must viewable at https://www.regulations.gov public submit reports, keep records, or
be submitted on or before February 26, or at the Dockets Management Staff provide information to a third party.
2018. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
electronic filing system will accept through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
comments until midnight Eastern Time • Confidential Submissions—To Agencies to provide a 60-day notice in
at the end of February 26, 2018. submit a comment with confidential the Federal Register concerning each
Comments received by mail/hand information that you do not wish to be proposed collection of information,
delivery/courier (for written/paper made publicly available, submit your including each proposed extension of an
submissions) will be considered timely comments only as a written/paper existing collection of information,
if they are postmarked or the delivery submission. You should submit two before submitting the collection to OMB
service acceptance receipt is on or copies total. One copy will include the for approval. To comply with this
before that date. information you claim to be confidential requirement, FDA is publishing notice
ethrower on DSK3G9T082PROD with NOTICES
with a heading or cover note that states of the proposed collection of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The With respect to the following
following way: Agency will review this copy, including collection of information, FDA invites
• Federal eRulemaking Portal: the claimed confidential information, in comments on these topics: (1) Whether
https://www.regulations.gov. Follow the its consideration of comments. The the proposed collection of information
instructions for submitting comments. second copy, which will have the is necessary for the proper performance
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The burden for this information work days within the parameters DEPARTMENT OF HEALTH AND
collection has changed since the last established for one or more other classes HUMAN SERVICES
OMB approval. Because of a slight of employees included in the Special
increase in the number of initial Exposure Cohort.’’ National Institutes of Health
registrations and product listing updates Period of Employment: January 1,
FDA has received during the past 3 Office of the Director; Notice of Charter
1971 through December 31, 1989. Renewal
years, we have increased our reporting
burden estimate. Frank Hearl In accordance with Title 41 of the
Dated: December 20, 2017. Chief of Staff, National Institute for U.S. Code of Federal Regulations,
Leslie Kux, Occupational Safety and Health. Section 102–3.65(a), notice is hereby
Associate Commissioner for Policy. [FR Doc. 2017–27724 Filed 12–22–17; 8:45 am] given that the Charter for PubMed
[FR Doc. 2017–27757 Filed 12–22–17; 8:45 am] BILLING CODE 4163–19–P Central National Advisory Committee
(PubMed) was renewed for an
BILLING CODE 4164–01–P
additional two-year period on December
DEPARTMENT OF HEALTH AND 8, 2017.
DEPARTMENT OF HEALTH AND HUMAN SERVICES It is determined that the PubMed is in
HUMAN SERVICES the public interest in connection with
National Institutes of Health the performance of duties imposed on
Decision To Evaluate a Petition To the National Institutes of Health by law,
Designate a Class of Employees From National Institute on Aging; Notice of and that these duties can best be
the Ames Laboratory in Ames, Iowa, Closed Meeting performed through the advice and
To Be Included in the Special counsel of this group.
Exposure Cohort Pursuant to section 10(d) of the Inquiries may be directed to Claire
Federal Advisory Committee Act, as Harris, Acting Director, Office of Federal
AGENCY: National Institute for amended, notice is hereby given of the Advisory Committee Policy, Office of
Occupational Safety and Health following meeting. the Director, National Institutes of
(NIOSH), Centers for Disease Control Health, 6701 Democracy Boulevard,
and Prevention, Department of Health The meeting will be closed to the
Suite 1000, Bethesda, Maryland 20892
and Human Services. public in accordance with the (Mail Code 4875), Telephone (301) 496–
provisions set forth in sections 2123, or harriscl@mail.nih.gov.
ACTION: Notice.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Dated: December 20, 2017.
SUMMARY: NIOSH gives notice of a as amended. The grant applications and
the discussions could disclose Michelle Trout,
decision to evaluate a petition to
designate a class of employees from the confidential trade secrets or commercial Program Analyst, Office of Federal Advisory
Committee Policy.
Ames Laboratory in Ames, Iowa, to be property such as patentable material,
included in the Special Exposure Cohort [FR Doc. 2017–27792 Filed 12–22–17; 8:45 am]
and personal information concerning
under the Energy Employees individuals associated with the grant BILLING CODE 4140–01–P
Occupational Illness Compensation applications, the disclosure of which
Program Act of 2000. would constitute a clearly unwarranted DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT: invasion of personal privacy. HUMAN SERVICES
Stuart L. Hinnefeld, Director, Division Name of Committee: National Institute on
of Compensation Analysis and Support, Aging Special Emphasis Panel; National Institutes of Health
National Institute for Occupational Developmental Programming and Aging.
Safety and Health, 1090 Tusculum Date: January 17, 2018. National Human Genome Research
Avenue, MS C–46, Cincinnati, OH Time: 11:00 a.m. to 2:30 p.m. Institute; Notice of Closed Meeting
45226–1938, Telephone 877–222–7570. Agenda: To review and evaluate grant Pursuant to section 10(d) of the
Information requests can also be applications. Federal Advisory Committee Act, as
submitted by email to DCAS@CDC.GOV. Place: National Institute on Aging, amended, notice is hereby given of the
SUPPLEMENTARY INFORMATION: Gateway Building, Suite 2W200, 7201 following meeting.
Authority: 42 CFR 83.9–83.12. Wisconsin Ave., Bethesda, MD 20892 The meeting will be closed to the
Pursuant to 42 CFR 83.12, the initial (Telephone Conference Call). public in accordance with the
proposed definition for the class being Contact Person: Greg Bissonette, Ph.D., provisions set forth in sections
evaluated, subject to revision as Scientific Review Officer, National Institute 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
warranted by the evaluation, is as on Aging, National Institutes of Health, as amended. The grant applications and
follows: Gateway Building, Suite 2W200, 7201 the discussions could disclose
Facility: Ames Laboratory. Wisconsin Avenue, Bethesda, MD 20892, confidential trade secrets or commercial
Location: Ames, Iowa. 301–402–1622, bissonettegb@mail.nih.gov. property such as patentable material,
Job Titles and/or Job Duties: ‘‘All (Catalogue of Federal Domestic Assistance and personal information concerning
employees of the Department of Energy, Program Nos. 93.866, Aging Research, individuals associated with the grant
its predecessor agencies, and their National Institutes of Health, HHS) applications, the disclosure of which
contractors and subcontractors who would constitute a clearly unwarranted
ethrower on DSK3G9T082PROD with NOTICES
Dated: December 18, 2017.
worked in any area at the Ames invasion of personal privacy.
Laboratory in Ames, Iowa, during the Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Name of Committee: Center for Inherited
period from January 1, 1971 through Disease Research Access Committee.
December 31, 1989, for a number of Committee Policy.
Date: January 12, 2018.
work days aggregating at least 250 work [FR Doc. 2017–27643 Filed 12–22–17; 8:45 am]
Time: 11:30 a.m. to 12:30 p.m.
days, occurring either solely under this BILLING CODE 4140–01–P Agenda: To review and evaluate grant
employment or in combination with applications.
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Document Created: 2017-12-23 03:08:56
Document Modified: 2017-12-23 03:08:56
| 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. | |
| Dates | Submit electronic or written comments on the collection of information by February 26, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 61013 |
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