[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8881-8883]
[DOCID:fr15fe08-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0073] (formerly Docket No. 2002N-0418)

Agency Information Collection Activities: Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 FDA's adverse experience reporting (AER) for
licensed biological products, and general records associated with the
manufacture and distribution of biological products.

DATES: Submit written or electronic comments on the collection of
information by April 15, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

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 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.

Adverse Experience Reporting for Licensed Biological Products; and
General Records --21 CFR Part 600 (OMB Control Number 0910-0308)--
Extension

    Under the Public Health Service Act (42 U.S.C. 262), FDA is
required to ensure the marketing of only those biological products
which are safe and effective. FDA must, therefore, be informed of all
adverse experiences occasioned by the use of licensed biological
products. FDA issued the

AER requirements in part 600 (21 CFR part 600) to enable FDA to take
actions necessary for the protection of the public health in response
to reports of adverse experiences related to licensed biological
products. The primary purpose of FDA's AER system is to flag
potentially serious safety problems with licensed biological products,
focusing especially on newly licensed products. Although premarket
testing discloses a general safety profile of a biological product's
comparatively common adverse effects, the larger and more diverse
patient populations exposed to the licensed biological product provides
the opportunity to collect information on rare, latent, and long-term
effects. Reports are obtained from a variety of sources, including
patients, physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the AER system contributes
directly to increased public health protection because such information
enables FDA to recommend important changes to the product's labeling
(such as adding a new warning), to initiate removal of a biological
product from the market when necessary, and to assure the manufacturer
has taken adequate corrective action if necessary.
    The regulation in Sec.  600.80(c)(1) requires licensed
manufacturers to report each adverse experience that is both serious
and unexpected, whether foreign or domestic, as soon as possible but in
no case later than 15 calendar days of initial receipt of the
information by the licensed manufacturer. These are known as
postmarketing 15-day Alert reports. Section 600.80(c)(1) also requires
licensed manufacturers to submit any followup reports within 15
calendar days of receipt of new information or as requested by FDA.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
Alert report for an adverse experience obtained from a postmarketing
clinical study only if there is a reasonable possibility that the
product caused the adverse experience. Section 600.80(c)(2) requires
licensed manufacturers to report each adverse experience not reported
in a postmarketing 15-day Alert report at quarterly intervals, for 3
years from the date of issuance of the biologics license, and then at
annual intervals. The majority of these periodic reports will be
submitted annually because a large percentage of currently licensed
biological products have been licensed longer than 3 years. Section
600.80(i) requires licensed manufacturers to maintain for a period of
10 years records of all adverse experiences known to the licensed
manufacturer, including raw data and any correspondence relating to the
adverse experiences. Section 600.81 requires licensed manufacturers to
submit, at an interval of every 6 months, information about the
quantity of the product distributed under the biologics license,
including the quantity distributed to distributors. These semiannual
distribution reports provide FDA with important information about
products distributed under biologics licenses, including the quantity,
certain lot numbers, labeled date of expiration, number of dosage
units, and date of release. Under Sec.  600.90, a licensed manufacturer
may submit a waiver request for any requirements that applies to the
licensed manufacturer under Sec.  600.80 and 600.81. A waiver request
submitted under Sec.  600.90 must include supporting documentation.
    Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections.
    Section 600.12 requires, among other things, concurrently with the
performance of each step that all records of each step in the
manufacture and distribution of a product be made and retained for no
less than 5 years after the records of manufacture have been completed
or 6 months after the latest expiration date for the individual
product, whichever represents a later date. In addition, manufacturers
must maintain records of sterilization of equipment and supplies,
animal necropsy records, and records in cases of divided manufacturing
of a product. Section 600.12(b)(2) requires manufacturers to maintain
complete records pertaining to the recall from distribution of any
product.
    Respondents to this collection of information are manufacturers of
biological products. Under table 1 of this document, the number of
respondents is based on the estimated number of manufacturers that
submitted the required information to the Center for Biologics
Evaluation and Research and Center for Drug Evaluation and Research,
FDA, in fiscal year (FY) 2006. Based on information obtained from FDA's
database system, there were 88 licensed biologics manufacturers. This
number excludes those manufacturers who produce blood and blood
components and in-vitro diagnostic licensed products, because Sec.
600.80(k) specifically exempts manufacturers of these products from
adverse experience reporting requirements. The total annual responses
are based on the estimated number of submissions received annually by
FDA in FY 2006. However, not all manufacturers have submissions in a
given year and some may have multiple submissions. There were an
estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179
lot distribution reports submitted to FDA. The number of 15-day Alert
reports for postmarketing studies under Sec.  600.80(e) is included in
the total number of 15-day Alert reports. FDA received 6 requests for
waiver under Sec.  600.90, all of which were granted. The hours per
response are based on FDA experience. The burden hours required to
complete the MedWatch Form for Sec.  600.80(c)(1), (e), and (f) are
reported under OMB control no. 0910-0291.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
600.80(c)(1) and                  88             270.85             23,835                  1             23,835
 600.80(e)
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600.80(c)(2)                      88             248.55             21,872                 28            612,416
----------------------------------------------------------------------------------------------------------------
600.81                            88               2.03                179                  1                179
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600.90                             6                  1                  6                  1                  6
----------------------------------------------------------------------------------------------------------------

Total                                                                                636,436
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Under table 2 of this document, the number of respondents is based
on the number of manufacturers subject to those regulations. Based on
information obtained from FDA's database system, there were 303
licensed manufacturers of biological products in FY 2006. However, the
number of recordkeepers listed for Sec.  600.12(a) through (e)
excluding (b)(2) is estimated to be 112. This number excludes
manufacturers of blood and blood components because their burden hours
for recordkeeping have been reported under 21 CFR 606.160 in OMB
control no. 0910-0116. The total annual records is based on the annual
average of lots released (5,291), number of recalls made (1,841), and
total number of adverse experience reports received (45,707) in FY
2006. The hours per record are based on FDA experience.
    FDA estimates the burden of this recordkeeping as follows:

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual        Hours per         Total Hours
                     Recordkeepers      Recordkeeping         Records          Recordkeeper
----------------------------------------------------------------------------------------------------------------
600.12                           112              47.24              5,291                 32            169,312
----------------------------------------------------------------------------------------------------------------
600.12(b)(2)                     303               6.08              1,841                 24             44,184
----------------------------------------------------------------------------------------------------------------
600.80(i)                         88             519.40             45,707                  1             45,707
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Total                                                                                259,203
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2890 Filed 2-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Rules and Regulations]
[Pages 2011-2013]
[FR Doc No: 2015-00465]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2013-0018]
RIN 1625-AA01

Anchorage Regulations; Port of New York

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing and modifying anchorage
grounds within the Port of New York. This action is necessary to
facilitate safe navigation and provide safe and secure anchorages for
vessels operating in the area. This rule is intended to increase the
safety of life and property of both the anchored vessels and those
operating in the area, as well as provide for the overall safe and
efficient flow of commerce.

DATES: This rule is effective February 17, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0018]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Jeff Yunker, Sector New York, Waterways Management
Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, Email
<EMAIL_ADDRESS>or Chief Craig Lapiejko, Coast Guard First
District Waterways Management Branch, telephone<PHONE_NUMBER>, Email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
WAMS Waterways Analysis and Management System

A. Regulatory History and Information

    On July 25, 2013, we published a notice of proposed rulemaking
(NPRM) entitled Anchorage Regulations; Port of New York in the Federal
Register (78 FR 44917). We received no comments on the proposed rule.
No public meeting was requested, and none was held.

B. Basis and Purpose

    The legal basis for this rule is 33 U.S.C. 471, 1221 through 1236,
2071; 33 CFR 1.05-1; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to define
anchorage grounds.
    This rule was assessed as part of a Waterways Analysis and
Management System (WAMS) review of the New York Vessel Traffic Lanes
and Approaches to New York Harbor with the intent of optimizing the
waterway and aids to navigation. The Coast Guard received six responses
to the survey included in the WAMS review. The survey responses
reported that Anchorage Ground No. 27(ii) Romer Shoal and Anchorage
Ground No. 27(iii) Flynns Knoll, near Sandy Hook, NJ are not used
because their locations leave vessels exposed to swells and that there
are safer anchorage grounds available in Lower New York and Sandy Hook
Bays.
    The New York District Army Corps of Engineers (USACE) was consulted
on this regulation and had no objections.
    In addition, the Hudson River Pilots Association requested the
Coast Guard

establish a federal anchorage ground near Yonkers, NY on the Hudson
River.
    The purpose of this rule is to accommodate ship traffic awaiting
berthing space, favorable weather, daylight hours, tidal conditions for
transits, and/or other unforeseen conditions to improve navigation
safety; clarify positions of current areas being used for vessels
anchoring; and reduce regulatory burden by disestablishing anchorage
grounds that are no longer used and therefore deemed unnecessary.

C. Discussion of Comments, Changes and the Final Rule

    The Coast Guard did not receive any comments to the proposed rule,
and no changes were made to the regulatory text.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect minimal additional cost impacts to the industry because
this rule is not imposing fees, permits, or specialized requirements
for the maritime industry to utilize these anchorage grounds. The
effect of this rule will not be significant as it removes two obsolete
anchorage grounds that are no longer used and codifies one anchorage
ground that is currently used by commercial vessels as a general
anchorage area. This will represent an improvement to the safety of
vessels using the anchorage grounds, facilitate the transit of deep
draft vessels through the adjoining waterways, and increase mariner
awareness that they can expect to find anchored vessels in the
vicinity.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels that have a need
to anchor or transit through the lower Hudson River near Yonkers, NY;
and Lower New York Bay near Romer Shoal and Flynns Knoll near Sandy
Hook, NJ.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule only codifies current navigation practices already in use by
commercial vessels in these areas. The anchorage grounds will not
affect vessels' schedules or their abilities to freely transit near
these areas within the Captain of the Port zone. The anchorage grounds
will not impose any monetary expenses on small entities because it does
not require them to purchase any new equipment, hire additional crew,
or make any other expenditures.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule does affect your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to

health or risk to safety that may disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
determination that this action is one of a category of actions that do
not individually or cumulatively have a significant effect on the human
environment. This rule involves disestablishing two unused anchorage
grounds, establishing one anchorage ground, and reducing the size of
one anchorage ground resulting in a reduction in the overall size of
the anchorage grounds by 7.28 square nautical miles in the COTP zone.
This rule is categorically excluded from further review under paragraph
34(f) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

0
1. The authority citation for part 110 continues to read as follows:

    Authority: 33 U.S.C. 471, 1221 through 1236, 2071; 33 CFR 1.05-
1; Department of Homeland Security Delegation No. 0170.1.

0
2. In Sec.  110.155 revise paragraphs (c)(2) and (f) and add paragraph
(c)(4) to read as follows:

Sec.  110.155  Port of New York.

* * * * *
    (c) * * *
    (2) Anchorage No. 17. All waters of the Hudson River bound by the
following points: 40[deg]56'26.66'' N, 073[deg]55'12.06'' W; thence to
40[deg]56'22.54'' N, 073[deg]54'49.77'' W; thence to 40[deg]55'56.00''
N, 073[deg]54'58.00'' W; thence to 40[deg]55'54.15'' N,
073[deg]54'46.96'' W; thence to 40[deg]54'18.43'' N, 073[deg]55'21.12''
W; thence to 40[deg]52'27.59'' N, 073[deg]56'14.32'' W; thence to
40[deg]51'34.20'' N, 073[deg]56'52.64'' W; thence to 40[deg]51'20.76''
N, 073[deg]57'31.75'' W; thence along the shoreline to the point of
origin (NAD 83).
    (i) When the use of Anchorage No. 17 is required by naval vessels,
the vessels anchored therein shall move when the Captain of the Port
directs them.
    (ii) [Reserved]
* * * * *
    (4) Anchorage No. 18. All waters of the Hudson River bound by the
following points: 40[deg]56'54.0'' N, 073[deg]54'40.0'' W; thence to
40[deg]56'51.0'' N, 073[deg]54'24.0'' W; thence to 40[deg]55'53.0'' N,
073[deg]54'40.0'' W; thence to 40[deg]55'56.0'' N, 073[deg]54'58.0'' W;
thence to the point of origin (NAD 83).
    (i) This anchorage ground is reserved for use by ships only.
    (ii) [Reserved]
* * * * *
    (f) * * *
    (2) Anchorage No. 27. Atlantic Ocean--
    (i) All waters bound by the following points: 40[deg]28'49.27'' N,
074[deg]00'12.13'' W; thence to 40[deg]28'52.12'' N, 074[deg]00'00.56''
W; thence to 40[deg]28'40.88'' N, 073[deg]58'51.95'' W; thence to
40[deg]25'57.91'' N, 073[deg]54'55.56'' W; thence to 40[deg]23'45.55''
N, 073[deg]54'54.89'' W; thence to 40[deg]23'45.38'' N,
073[deg]58'32.10'' W; thence along the shoreline to the point of origin
(NAD 83).
    (ii) [Reserved]
    (iii) [Reserved]
* * * * *

    Dated: December 30, 2014.
V.B. Gifford,
Captain, U.S. Coast Guard, Acting Commander, First Coast Guard
District.
[FR Doc. 2015-00465 Filed 1-14-15; 8:45 am]
BILLING CODE 9110-04-P